MAIA Biotechnology, Inc. is a targeted therapy, immune-oncology company, focused on development of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
If you’re interested in working at MAIA, please review the current openings below and send your CV to careers@maiabiotech.com.
Current Openings
General Counsel and Corporate Secretary
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Actively provides cross-functional advice and counsel on a wide range of legal, regulatory and commercial matters as a key member of the executive leadership team; these issues will include policy formulation, allocation of resources and achievement of the Company’s overarching strategies.
- Working interactively with finance, corporate development, operations and research and business development teams to identify and build strategic assets of Company, including identifying, researching and developing market opportunities and collaborations.
- Guiding and advising the Board and executive management team on their responsibilities under the rules and regulations to which they are subject, including regulatory and compliance related matters.
- Active and engaged counseling on both the business and legal ramifications of significant Company strategic imperatives, including possible acquisitions, license agreements, joint ventures, other possible investments and negotiating and structuring major transactions.
- Advising on the litigation and regulatory risks of possible business decisions; counseling on the appropriate strategies to defend or resolve litigation associated with complex matters, such as intellectual property, antitrust/competition, government investigations and other matters.
- Actively supervising and advising on all aspects of intellectual property and specifically with respect to patent prosecution and litigation and the licensing in and out of technologies; advising on antitrust and international competition laws as they relate to intellectual property.
- Acting as the Company’s Chief Compliance Officer and overseeing the development and dissemination of compliance policies that will ensure that the Company is in compliance with all laws, rules and regulations that may apply to Company’s activities; monitoring the regulatory landscape and anticipating changing regulations and policies and their impact on the Company.
- Leading and coordinating the legal services provided to the Company by outside counsel; overall administrative and financial management relating to the legal department; choosing and managing outside counsel; establishing procedures for evaluating the quality and cost of services of outside counsel
- Perform Corporate Secretary function. Prepare materials for all Board and Committee meetings and collaborate with members of senior management in developing and/or reviewing materials provided to the Board and its Committees. Prepare and/or review updates to corporate governance policies and other corporate governance documents, including governance guidelines and committee charters, and coordinate director independence determinations.
EDUCATION and/or EXPERIENCE
- The successful candidate should hold a law degree from an American law school and be a member of the bar, although it is not necessary for the attorney to be a member of any specific state bar. A track record of academic distinction and a law degree from a top tier law school are required.
- At least 15 years of experience, with 5 years’ experience in the biotech, pharmaceutical or medical device industry.
- Excellent interpersonal, communications, public speaking, and presentation skills.
- Experience counseling senior executives, boards of directors and their committees and individual board members on a range of legal, compliance and governance matters.
- Significant transactional experience.
- Experience supervising complex litigation matters.
- Experience supervising the provision of legal services.
- Experience supervising an effective, business aligned intellectual property law function with respect to the prosecution and litigation of patents and other forms of intellectual property is desired; a deep understanding of the importance of an actively managed intellectual property portfolio of patents as a fundamental corporate asset and the importance of developing a robust patent strategy with respect to the protection of technology and the licensing in and out of technology.
- Consistently exhibit through actions, decisions and interactions (internally and externally), the highest standards of ethics and integrity.
- Travel estimated at 25%.
Director of Investor Relations
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
DIRECTOR OF INVESTOR RELATIONS
This role will report directly to the Chief Financial Officer to develop and execute an IR strategy that will promote the Company’s business objectives and articulate a compelling and digestible message to the market to drive value creation. This position requires someone to have a strong scientific background, financial acumen, existing relationships within the investment community, the ability to steer business performance and make important decisions.
*This is a remote position. Must be based in the United States. Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Partner with key members of the senior management team to lead and manage the company’s participation on quarterly earnings calls, investment conference calls and in-house meetings, road shows, analyst days, one-on-one meetings and media interviews
- Direct interaction and communication with all existing and potential shareholders; maintain and cultivate sell-side investment analyst coverage and interest from the buy side institutional investment community. Monitor and evaluate investor landscape in the genomic medicine space and proactively plan outreach.
- Analyze current stockholder base and investing trends of institutional investors and conduct investor targeting; monitor top shareholder composition trends over time
- Partner with senior management and investment bankers to develop ESG platform and messaging and execute shareholder targeting exercises
- Collaborate with colleagues throughout the company in establishing the development, and the detailed execution of the IR operating plan
- Collaborate senior leadership in the creation of the company’s external and internal messaging and ensure all investor communications are integrated and consistent
- Lead investor communications development, including preparing presentation decks, developing earnings releases, creating management Q&As, conference call scripts, and the business section of the Form 10K. Contributing to the drafting of other SEC documents as required
- Present and articulate the investor point of view to the executive team, and make recommendations as necessary and appropriate
- Maintains and develops a positive public image for the organization.
- Analyzes corporate activities for investors, identifying networking and other opportunities to build and create new initiatives.
- Produces quarterly and annual shareholder reports.
Qualifications:
- Bachelor’s degree required; advanced degree preferred
- Investor relations, corporate communications or equity research (buy-side or sell-side) experience within or covering biotechnology or pharmaceutical companies. Experience at a reputable, well-regarded organization is essential
- Strong financial acumen
- Strong understanding of the capital markets
- Strong reputation with Wall Street analysts and institutional investors
- Track record of successfully building a corporate profile
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Head of Regulatory Affairs
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
HEAD OF REGULATORY AFFAIRS
This role will report directly to the Chief Medical Officer and will be responsible for leading the development and implementation of a consolidated regulatory strategy to secure and maintain market access for products through all development phases. The Head of Regulatory Affairs will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for US FDA, EMA, and other key market Health Authorities as applicable and ensure these activities are consistent with the overall global strategy and activities. An integral part of this role is to foster strong relationships and advocacy with FDA as well as other international regulatory authorities, as required. This leadership role will entail oversight of CROs for the preparation of the regulatory submissions and interaction with key members of the Project Teams, agencies/health authorities to obtain and maintain product approvals.
*This is a remote position. Domestic and occasional international travel may be required. Must be based in the United States. Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Develop, lead and implement global regulatory strategy.
- Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities, including meeting requests, briefing packages, and fast track applications.
- Act as primary strategic contact with the US FDA, EMA, and other key market Health Authorities as applicable to enable execution of company regulatory goals.
- Partner with the CRO in developing and leading all regulatory strategies and activities
- Provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
- Provide direct Regulatory oversight to all Non-clinical, Clinical and CMC activities.
- Lead the preparation of submissions, which may include INDs, Briefing Documents, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.
- In collaboration with appropriate team members (e.g., clinical development, clinical operations, biostatistics) assist in the design of clinical study protocols, development of statistical and interim analysis plans, and interpretation of clinical study data.
- Support preparation of Pediatric Study Plans and other pediatric applications
- Support preparation of Orphan drug designation requests for submission to FDA & EMA
- Provide input to the Regulatory Affairs portion of proposals, budgets and contracts
- Identify and assess regulatory risks for projects or programs.
- Participate in audits as required; oversee follow-up activities and ensure timely implementation and completion of corrective action plans in close cooperation with QA.
- Support product launch and commercialization activities.
- Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to Company personnel and assist as a liaison between the Company and regulatory authorities.
- Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future products.
- Communicate project regulatory strategies and plans to management, cross functional teams and any partners/collaborators to establish alignment.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice.
- Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
- Participates in Business Development efforts, as applicable.
Qualifications:
- Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 12+ years pharmaceutical industry experience, including 10 years in Regulatory Affairs. Global experience desired.
- Experience in multiple phases of development in various therapeutic areas. Experience in oncology therapeutic areas a plus.
- Experience leading a Regulatory Affairs function, specifically the designing, writing, and submission of regulatory filings and correspondence within a complex specialty/branded commercial pharmaceutical organization. Preferred candidates will have experience leading the submission process for both new entities and line extensions of existing products. Experience supporting commercialization and post-marketing activities and requirements for approved products in North America.
- Strong leadership competencies and strategic business perspectives are required to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development, and post-marketing activities.
- Knowledge of the drug development process and global submission process.
- Demonstrated experience in preparing FDA submissions.
- Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
- High level partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
- Must be able to innovate, analyze and solve problems with attention to detail.
- S/he must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. This person will demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards. S/he will be entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Head of Business Development
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
HEAD OF BUSINESS DEVELOPMENT
This role will report directly to the Chief Executive Officer to support corporate strategic planning process by overseeing the analysis, identification, and pursuit of new business opportunities.
*This is a remote position that may require the ability to travel up to 50%. Must be based in the United States.
Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Identify, develop, and prioritize key strategic incentives to generate profitable new business opportunities.
- Manage the development of customer relationships by leveraging business contacts and by identifying prospective customers.
- Identify and implement tactical business development strategies which will meet the needs of the marketplace and yet protect the organization’s intellectual property and business interests
- Responsible for ensuring that the objectives of all alliances are achieved, company assets are protected, complexities are managed or reduced, and that opportunities to enhance the value of the alliances are recognized and pursued.
- Develop and close contracts with pharmaceutical and biotechnology customers.
- Assess potential markets to make recommendations for new projects: including acquisitions, licensing agreements and other business collaborations.
- Lead the sourcing, negotiation, and execution of new business development opportunities.
- Plan and evaluate projects for financial viability and marketing strategy.
- Creates financial projections for growth and profitability of future business acquisitions.
- Estimates demand for proposed projects based on market research and consumer trends.
- Provides support in deal negotiations, contract development, due diligence and other business development or alliance development projects.
- Attend key conferences as a representative of the company and assist in the planning and implementation of company presence at said conferences.
- Interface with internal Senior Management to implement strategic business proposals and oversee its successful execution.
Qualifications:
- Bachelor’s degree in business or related field. MBA and/or PHD in a scientific discipline is preferred.
- Oncology Business Development experience is strongly preferred.
- Ten (10+) plus years business experience in the pharmaceutical or biotechnology field.
- A very strong knowledge of pharmaceutical and / or biotechnology companies
- Strong financial modeling/ statistical/computer background particularly in the pharmaceutical/biotech field.
- Experience and ability to manage a large staff and multiple concurrent technical projects is required. The ability to interact in multi-functional teams and influence people to work together is essential.
- Must be able to demonstrate an ability to lead business and technical discussions internally and externally. Must be experienced with and capable of explaining scientific concepts.
- Position will require influencing both internal and external constituencies, including working closely with project/portfolio teams and senior leaders across different functional groups within the Company and its partners. The ideal candidate will be both strategic as well as tactical when required.
- Detail oriented and strong written and verbal communication skills.
- Must be familiar with Microsoft Office applications.
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Head of Human Resources
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
HEAD OF HUMAN RESOURCES
This role will report directly to the Chief Executive Officer and will be responsible for the planning, developing, implementing and the overall administration of Human Resources programs in the areas of benefits, employee relations, performance management, training, talent acquisition, compensation and HRIS.
*This is a remote position. Must be based in the United States.
Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Lead recruitment efforts for the Company
- Develop, propose, publish, make recommendations, implement, and consistently administer human resources policies, programs, practices, and procedures
- Work closely with all levels of organization management relative to personnel related matters, internal investigations, and employee conflict resolution.
- Manage employee onboarding, including offer letter generation, background checks, coordination of new hire systems and resources, conduct new hire orientation, process paperwork, benefits enrollment, etc.
- Coordinate employee off-boarding, including exit interview, exit paperwork, system deactivation, final paycheck, equipment collection, etc.
- Develop, implement, and administer effective compensation and benefit programs that contribute to the organization’s ability to attract, retain and motivate employees
- Administer employee benefits, including broker/ vendor relationships, enrollment, claims resolution, general employee inquiries and invoice processing.
- Communicate to all levels of the organization via verbal or written form changes, developments, or responses relative to human resources policies, programs, practices, and procedures.
- Design, develop, and implement training and organizational development initiatives from both internal and external sources to ensure human resources best practices.
- Maintain compliance with federal, state and local employment laws, including completion of mandatory reporting.
- Project manage the annual employee performance review process, including budget approval, project timeline and overall execution.
- Partner with client groups to focus on building the Company’s culture, including team development, conflict resolutions and fostering an environment of open feedback and communication.
Qualifications:
- A Bachelor’s Degree required; advanced degree preferred
- A minimum of 8-10 years of progressive HR experience with broad generalist knowledge in employee relations, training, performance management, compensation, organizational development, and talent acquisition.
- Experience in the biopharmaceutical industry desired.
- Working knowledge of federal and state labor and employment law
- Understanding of HR best practices and current local regulations
- Excellent verbal and written communication and presentation skills.
- Ability to exercise good judgment and provide strategic advice.
- Ability to effectively interact with employees at all levels of the Company.
- Effective customer service skills.
- Excellent teamwork and interpersonal communication skills
- Ability to manage a high volume of work.
- Strong relationship building and coaching skills at all levels of the organization
- Excellent project management and organizational skills
- Solid business acumen, with ability to analyze data, manage budgets and measure results and effectiveness of programs
- Ability to prioritize workload and self-manage projects, handle multiple tasks, and meet deadlines
- Proficiency in Microsoft Office Suite, ADP, and Ease.
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Head of Information Technology
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
HEAD OF INFORMATION TECHNOLOGY
This role will report to the Chief Executive Officer and will own and drive the long-term strategy for the Company’s IT systems with an emphasis on security, productivity, and scalability. This position will manage and build the IT capabilities and act as a trusted advisor to the business to proactively identify technology needs and implement effective solutions. The Head of IT will be responsible for all aspects of corporate IT infrastructure, networking, and data security and must have a proven track record of building relationships formed upon trust, credibility, and impact in support of a rapidly growing and integrated biotechnology company. Ability to “roll up your sleeves” and individually contribute results to a research and development effort.
*This is a remote position. Must be based in the United States. Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Define and implement the Company’s strategic roadmap working closely with business leaders to identify present and future IT needs
- Understand the organization’s goals, objectives, and strategic direction to identify opportunities for technology solutions across various departments. Partner with business to define the requirements for new solutions and ensure solutions implementation meet the business needs including comprehensive deployment support, training, user support, and metrics to evaluate value delivery
- Establish and build relationships with vendors, including evaluating vendor capacity and security and leading negotiations relating to all IT needs. Manage help desk and external IT vendors and ensure that end users receive optimal support to maximize their productivity
- Oversee and enforce IT policies, procedures and associated plans for security, data center, and infrastructure based on industry-standard best practices as well as SOX, HIPAA, GDPR, PHI, FDA, and privacy requirements
- Plan and ensure implementation for updates and maintenance of all IT infrastructure needs with minimal impact on end users
- Oversee security of systems, networks, and enterprise information. Complete regular cyber security assessments and IT security audits and investigations. Define gaps, identify solutions, and implement, as needed.
- Oversee purchasing of hardware and software products and management of software and support licenses.
- Prepare and manage detailed IT budgets and resource plans to enable the company to meet its short-term and long-term goals
Qualifications:
- BS in Computer Science required; advanced degree preferred
- Experience managing and implementing IT solutions in a start-up environment
- Experience building and scaling IT infrastructure to support a small company in high growth mode
- Comprehensive knowledge of essential IT functions including network infrastructure, storage, servers, databases, cloud computing, ERP, disaster recovery, security, telecommunications, and vendor management
- Experience leading IT teams consisting of onsite resources, contractors, consultants, and managed services providers
- End-to-end solutions implementation experience, including identification, deployment, roll-out, training, and user support
- Experience migrating/upgrading technologies enterprise-wide
- A proactive partner with the demonstrated ability to confidently engage with key stakeholders to gain an understanding of the business’ evolving IT needs, develop and recommend innovative and cost-effective solutions
- Ability to identify and deploy solutions to enhance the effectiveness of a complex, scientific, data-driven organization
- Superior organizational, planning, and project management skills
- Strong written and oral communication skills
- Demonstrated strong leadership and written/verbal communication skills
- Collaborative work style in a hands-on team-oriented environment
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Head of Quality Assurance / Compliance
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
HEAD OF QUALITY ASSURANCE / COMPLIANCE
This role will report directly to the Chief Medical Officer and is responsible for the implementation and delivery of an efficient, effective, and compliant GMP and GCP Quality program that meets internal company standards and health authority guidelines and regulations. This position requires someone to have demonstrated ability to work in early startup and growth stage companies.
*This is a remote position. Must be based in the United States. Excellent compensation package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Provides leadership, strategy, and compliance oversight of GMP and GCP global program execution, including leading routine governance activities that provide visibility to program effectiveness and compliance.
- Collaborates with Manufacturing, Clinical Operations, R&D, Pharmacovigilance, Regulatory Affairs in the development of processes, procedures and training programs that improve the efficiency, effectiveness and/or state of compliance of the Clinical Program internally to the company or with external clinical service providers.
- Subject matter expert who provides expertise to project teams and supports programs by conducting compliance reviews of clinical documentation (i.e. clinical study reports, clinical study protocols, investigator brochures) and manufacture drug product release documents.
- Leadership and accountability for the GCP audit strategy and program. This includes the strategy and risk-based approach to clinical study site audits, trial master file audits, qualification audits
- Monitor the work of the Sponsor Audit and Inspection Lead team to ensure consistency and quality within the group.
- Maintain knowledge of project / audit status in assigned areas and provide Senior Management with current informational reports upon request.
- Maintain current records / documents related to assigned areas.
- Leads Health Authority inspection readiness preparations that assure successful outcomes
- To effectively lead, manage, develop, and implement assigned projects. To provide leadership and management support and guidance to the team.
- To exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically.
- Develops an engaged and motivated team of Clinical QA professionals
Qualifications:
- BS/BA in science related field; advanced degree preferred
- Working knowledge and experience of GCP/GLP regulations/ guidelines (ICH, US FDA, ISO)
- Excellent communication (verbal and written) skills and ability to effectively lead teams
- Minimum 5-7 years of relevant experience in Quality related role in the pharmaceutical industry with at least 2-3 years of leadership experience.
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Head of Manufacturing
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
HEAD OF MANUFACTURING
This role will report directly to the Chief Executive Officer to provide leadership, strategy and oversee execution in advancing small molecules from pre-clinical manufacturing to late-stage clinical trials and eventual registration. The person will lead critical scientific, regulatory, and business functions pertaining to drug substance and drug product for Maia including authoring of (1) regulatory submissions for worldwide filings, (2) development of chemical processes for active pharmaceutical ingredients (drug substance), process scale-up, technology transfer and validation of chemical processes and effective management and (3) development of formulation for drug products, process scale-up, technology transfer and validation of formulation processes and effective management of CROs and CMOs to accomplish these activities.
*This is a remote position. Must be based in the United States.
Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Lead scale-up, process development, and finalization (validation) of the process for clinical and commercial-scale manufacturing of drug substances.
- Manage and oversee drug product formulation development, process development, optimization, clinical supply and registration batch manufacturing, packaging, and process validation activities including selection of external contract development and manufacturing organizations (CDMOs). The person must have experience with parenteral formulations and GMP manufacturing.
- Delivery of a successful drug substance manufacturing process validation.
- Work with supply chain, logistics and clinical supply management in support of clinical trials.
- Establish critical raw material attribute control and in-process control strategies.
- Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controls following regulatory guidance and QbD principles in accordance with the cGMP requirements to ensure on-time delivery of the drug product.
- Ensure that CRO/CDMO activities and other process development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launch.
- Establish the drug substance and drug product formulation and process development strategies based on the project’s Target Product Profile.
- Author/review GMP documentation, i.e. batch records, specifications, and protocols with Quality Assurance.
- Oversee the batch manufacturing, intermediate sampling, intermediates, and finished product characterization.
- Review executed batch records, protocols, and reports related to all GMP operations.
- Conduct appropriate range finding and critical process parameter studies for the drug substance and drug product preparing for registration and validation batches Responsible for planning, documenting, and overseeing the execution of all relevant PPQ/PPV protocols.
- Oversee the development and implementation of stage appropriate analytical methods and protocols for timely testing of new drug products, and the designing and initiating of stability studies on selected batches.
- Work collaboratively with Product Development, Quality Assurance and Regulatory Affairs to ensure a high-quality level of cGMP and the worldwide regulatory guidances are followed.
- Participate in the compilation of IND/NDA and IMPD/MAA and other regulatory dossiers for global product development.
- Established and maintain CMC budget for assigned projects.
Qualifications:
- Advanced degree in Pharmaceutics, Chemical Engineering, Bioengineering, Chemistry, Pharmaceutical Chemistry or related scientific discipline.
- 15+ years of experience in the Pharmaceutical or Biotech industry with a focus on small molecule drug development and manufacturing.
- Strategic oversight and execution in manufacturing drug substance and drug product for all stages of clinical trials.
- Demonstrated experience in managing drug substance chemical development, process validation, and manufacturing in support of NDA marketing applications and commercial production.
- Demonstrated track record of delivering candidate(s) into chemical manufacturing and commercialization.
- A proven track record in developing and scaling up parenterals and oral solid dosage forms from pre-IND through Process Validation using Quality by Design (QbD) concepts and design of experiments (DoE).
- Extensive experience in product development, clinical supply, and registration batch manufacturing for oral solid dosage product development.
- Experience in the contract manufacturing environment with an in-depth knowledge of unit operations for small molecule drug products.
- Experience as the primary author of relevant sections of IND’s and NDA’s.
- Ability to effectively work independently in a team environment and substantial experience with managing external CDMOs to meet timelines within the approved budgets.
- Track record of building, leading and developing a successful CMC team
- The person must be able to travel as required to the CDMO’s, as needed.
- Highly effective written and verbal communication skills
- Highly collaborative, self-motivated and team oriented
- Strong interpersonal skills
- Ability to balance multiple data sources, weigh decisions, and drive progress
- Ability to grasp concepts and ideas quickly and thrive in a fast-paced environment
- Anticipates potential challenges and develops mitigation strategies
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Head of Biostatistics
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
HEAD OF BIOSTATISTICS
This role will report directly to the Chief Medical Officer to provide statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research and development needs. This position will support statistical aspects of pre-clinical and clinical activities related to drug development in oncology and/or hematology along with other business-critical and/or regulatory commitments.
*This is a remote position. Must be based in the United States. Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Demonstrate advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives.
- Apply high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability.
- Ensure application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues.
- Produce clear, concise, well-organized, and error-free computer programs and statistical reporting content.
- Comply with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidances.
- Contribute high quality and timely deliverables as assessed by stakeholders such as the Project Team, the Clinical Trial Team, and the Statistics Area Head.
- Ensure that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.
- Acquire and demonstrate knowledge in pharmaceutical research and development strategies and execution.
- Assist in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support.
- Accountable for execution of individual project responsibilities, including meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.
- Provide critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.
- Establish and maintain effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management. Routinely contribute to area of discovery, translational, early development, late development project meetings.
- Demonstrate full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.
- Deep knowledge of data architecture, such as Data Standards. Recognizes the need and value of process standardization.
- Participate as a member of professional organizations, such as attending meetings sponsored by professional organizations.
Qualifications:
- D. in Statistics or related field with minimum 5 years relevant experience, or MSc in Statistics with experience related to pharmaceutical drug development focused on oncology or hematology products.
- Basic knowledge of SAS or R programming.
- Good written, oral, and interpersonal communication skills.
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Head of Translational Research
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
HEAD OF TRANSLATIONAL RESEARCH
MAIA Biotechnology, an oncology drug development company focused on cancer telomere biology and immunotherapy is looking for an experienced Head of Translational Research to join our energetic and high-performance team. Working in partnership with the Chief Scientific Officer and in collaboration with the Clinical/Medical teams, will set up our biomarker and translational research department and lead the development and execution of biomarker development plans and patient selection strategies in different oncology and hematology indications.
Working remotely, the incumbent will be a vital part of shaping our translational strategy and biomarker vision. Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Provides scientific leadership in areas of biomarker discovery, development and translational science working with multiple cross-functional teams
- Collaborate with Clinical Development, Clinical Operations teams and external experts as appropriate to develop scientifically rigorous translational and exploratory biomarker strategies that assess proof of mechanism, establish early signs of efficacy, enable proof of concept studies, patient selection and generate an understanding of the variability in patient response
- Oversee companion diagnostics and biomarker development, select vendors and be involved in activities related to clinical sites and biomarker collection
- Partner with preclinical and drug discovery scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response
- Support scientific input and review of all translational medicine aspects of clinical and regulatory documents, including but not limited to development plans, study protocols, clinical study reports, regulatory submissions, and responses to any regulatory questions, etc.
- Propose and develop innovative methods and technologies as well as new directions for project development
- Function as a scientific and business thought-leader inside and outside of the company and a key link to external scientific & medical community.
Qualifications:
- PhD (and/or MD) with primary focus in either Cellular or Molecular Biology, Immunology, Cancer Biology and/or Pharmacology with at least 5 years of pharmaceutical or biotechnology industry experience in biomarker discovery and companion diagnostics, preferable in the hematology and/or oncology research areas
- Thorough understanding of clinical trials and clinical strategy, experience with oncology and/or hematology drug development as well as analytical and clinical validation of biomarker assays
- First-hand experience with identification and validation of pharmacodynamic and patient selection biomarkers and clinical implementation
- Ability to drive and influence projects from discovery through early clinical development with a focus on the identification of indications with biomarkers of response and/or resistance to therapy
- Expertise in establishing and running preclinical studies
- Familiarity with data management and visualization tools and collaborating with computational biology to analyze complex genomic data sets
- Passion for developing new cancer therapies
Competencies:
- Outstanding analytical, research and organizational skills
- Strong interpersonal, influencing and collaboration skills to work in a team-oriented, fast-paced environment
- Strong scientific communication skills to diverse audiences, and ability to present the results in a clear and concise manner
- Ability to prioritize, be highly productive and flexible in a fast-paced work environment.
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Senior Clinical Operations Director
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
SENIOR CLINICAL OPERATIONS DIRECTOR
This role will report directly to the Chief Medical Officer and is responsible for overall clinical program management of phase 0-III studies in oncology. The successful candidate will manage CROs, clinical sites, liaise with Finance and Operations/Program Management and be responsible for coordinating the clinical study reports and clinical sections of the IB, IND/CTAs and NDAs/MAAs.
*This is a remote position but may require some travel up to 50%. Must be based in the United States.
Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Participate as an integral team member in CRO selection, and provide primary oversight for RFPs, contract management and CRO management.
- Track and report clinical information regarding patient recruitment and screening, monitor visit schedules and coordinate other clinical study needs.
- Interact with active and potential clinical investigators.
- Conduct study monitoring visits and co-monitoring visits with CROs (as needed until a CRA is hired.)
- Organize meetings and teleconferences for clinical and safety issues.
- Work with CROs and/or clinical sites to design/review informed consent documents, CRFs, protocols, SAE reports and other study documentation.
- Organize and run meetings and teleconferences for clinical and safety issues for clinical studies.
- Coordinate clinical project timelines with Project Management to meet critical milestones; and/or escalate issues that may jeopardize timelines and deliverables.
- Liaise with other functional areas, such as Research, Preclinical Development, Program Management and Regulatory Affairs to accurately coordinate clinical study activity.
- Coordinate the writing of clinical study reports and clinical sections of the Investigators Brochure, INDs/CTAs and NDAs/MAAs.
- Work with Operations & Finance to develop budgets and cost estimates and track the financial status against budget.
- Maintain up-to-date knowledge of clinical principles and theories of drug development and study design in our therapeutic areas (oncology).
- Maintain clinical study files per ICH guidance.
- Manage CRAs to be hired in the future.
- Other duties as may be necessary.
Qualifications:
- Bachelor’s Degree with a science major preferred.
- 10+ years of clinical operations and overall drug development in the pharmaceutical/biotechnology industry.
- At least 3-5+ years of intimate knowledge of the oncology and/or hematology therapeutic area(s).
- Strong experience in management of CROs.
- Demonstrated skills in protocol, CRF, ICF and the development of study documentation.
- Knowledge of FDA regulations and ICH guidelines regarding GCPs.
- Phase 1-3 clinical trial experience, oncology or hematology preferred.
- Demonstrated Experience in writing reviewing the clinical sections of an IB, IND and/or NDA.
- Proficiency in strategizing, planning, monitoring and problem solving.
- Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing indirectly.
- Ability to manage multiple and diverse issues.
- Strong facilitation, organizational, analytical and time management skills.
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel, SharePoint and MS Project.
- Ability to apply knowledge to new situations.
- Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement.
- Ability to “roll up your sleeves” and individually contribute results to a research and development effort.
- Experience writing technical and management documents, reports and presentations.
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Clinical Trial Manager – Europe
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
CLINICAL TRIAL MANAGER – EUROPE
This role will report directly to the Chief Medical Officer and will be responsible for leading all aspects of global clinical trial management from study start through study closure.
*This is a remote position. Domestic and international travel may be required.
Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Manage all clinical aspects of a clinical trial and ensures trial execution in compliance with ICH/GCP guidelines/regulations and applicable SOPs
- Lead and collaborate effectively with cross-functional teams to oversee the setup, execution, and management of complex clinical trials according to plan and in the highest quality standards
- Can multi-task in a fast-paced environment with changing priorities and maintain accurate forecasts, clinical trial budgets, and timelines
- Assist in development and management of study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget
- Use operational and therapeutic expertise in oncology to optimize trial setup, implementation, and execution
- Proactively anticipate/identify study risks and issues, determine escalation pathway, and develop and implements solutions
- Conduct project risk analysis and develops risk mitigation strategies for a variety of complex problems to maintain study deliverables
- Provide technical expertise to oversee the development of clinical documents (protocol, informed consent form, CRF, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.
- Provide clinical operations expertise and strategic leadership in the evaluation, selection, and management of CROs and other external vendors to ensure successful clinical trial implementation and execution of clinical trials and ensure that performance expectations are met
- Provide expertise in the identification, engagement, and selection of key trial centers/PIs, as well as develop relationships with investigators and site staff
- Ensure audit-ready condition of clinical trial documentation and support inspection readiness activities
- Participate in the planning of quality assurance activities and coordinate resolution of audit findings, which includes management through resolution (CAPA) of any site or study level issues, deviations, etc.
- Actively provide direction and oversight and foster effective relationships with vendors, investigators, consultants, and colleagues
- Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
- Manage and mentor clinical team members, as needed
Qualifications:
- BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred
- Minimum of 5 to 7 years of experience in clinical research with 1-2 years managing trials in the biotech/pharma industry and/or prior CRO experience
- Experience in setup, execution, and oversight/operational management of oncology or relevant oncology trial experience
- Understand early phase/complex dose escalation
- Knowledge in how supply chain processes work in oncology trials.
- Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail
- Strong initiative and a can-do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet deadlines, proven effectiveness in a fast-moving and growing biotech environment
- Solid working knowledge in Good Clinical Practices and ICH Guidelines and the application to the conduct of clinical trials
- Proficient in MS Office Suite, and understanding Clinical Trial Management System, eTMF, and EDC systems, is required
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Accounting Manager
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
ACCOUNTING MANAGER
This role will report directly to the Chief Financial Officer to perform regular bookkeeping and accounting activities. This position requires someone to have demonstrated ability to work in early startup and growth stage companies.
*This is a remote position. Must be based in the United States.
Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Maintain accounting system
- Regular bookkeeping and accounting activities – monthly close, monthly reporting, and general financial administration
- Establish and perform procedures for setting up new vendors (contracts, W-9s) and paying monthly invoices; manage payables and cash disbursements
- Reconcile cash accounts, track cash usage and prepare cash flow projections
- Establish reporting template and perform monthly, quarterly and annual reporting (internal and external)
- Establish/maintain internal controls
- Work with the Company management team to prepare operating plans and budgets
- Input of budget in QuickBooks for variance analysis
- Manage insurance and banking relationships and service levels
- Monthly payroll/benefits administration
- Prepare and maintain purchase orders as back up for Accounts Payable
- Shareholder maintenance
- Update and manage the Company’s cap table
- Assist with tax returns, as appropriate
- Contribute to external reporting process including quarterly report on form 10-Q and annual report on form 10-K filed with the Securities and Exchange Commission. Assists in other filings that may arise
- Assist with preparing for and managing financial statement audits
Qualifications:
- Bachelor’s Degree in accounting, CPA or MBA a plus
- 10+ years accounting and finance experience (Big 4/CPA Firm experience a plus)
- Prior public accounting experience including SEC reporting experience, 10Q and 10K filing experience, etc.
- Computer Skills: QuickBooks and Excel a must
- Grant accounting experience a plus
- Knowledge of GAAP a plus
- Experience in Life Sciences industry
- Forecasting, budgeting, and tax compliance experience is a must
- Implementation of financial systems and ability to bring efficiencies
- Creative problem-solving skills including the ability to identify, recommend and implement solutions
- Strong interpersonal and client relationship skills
- Ability to communicate proactive solutions to identified opportunities for improvement
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Clinical Trial Associate / Contract Specialist
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
CLINICAL TRIAL ASSOCIATE / CONTRACT SPECIALIST
This role will report directly to the Senior Director, Clinical Operations and Development, to support our collaborative and successful Clinical Operations and Contract teams with operational activities.
*This is a remote position. Must be based in the United States.Excellent compensation package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Provide administrative support to various clinical projects and studies
- Maintain and track clinical study documentation, including TMF-related documents
- Collaborate with legal, finance and appropriate functional areas on the contract process
- Prepare, review, negotiate, and administer contracts and purchase orders
- Review cost proposals and pricing information
- Tracking vendor and CRO contracts and POs
- Participates in internal and external meetings, provides updates as required, may take minutes, or assist in action/decision log maintenance
- Data entry, tracking, scanning/copying, binder creation, and supply distribution
- Coordinate study materials
- Assists with ad hoc issue resolution as directed and delegated
- Interaction with vendor and CRO personnel
Qualifications:
- College Degree required, healthcare or life science degree a plus
- At least 5 years’ experience in clinical research
- Oncology experience a plus
- Demonstrated negotiation skills
- Strong administrative skills
- Organizational skills to support several team members
- Knowledge of contract principles and procedures
- Excellent written and verbal communication
- Working knowledge of computer systems, e.g., MS Word, Excel, Outlook, PowerPoint
- Skill in SharePoint is a plus
- Knowledge of medical terminology
- Exceptional attention to detail
- Able to work in a dynamic, changing environment
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.
Associate Director Biology Research
Overview:
See Your Future with MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. is a targeted therapy, immuno-oncology company focused on the development and commercialization of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
For more information, please visit www.maiabiotech.com.
ASSOCIATE DIRECTOR BIOLOGY RESEARCH
This role will report directly to the Chief Scientific Officer to effectively implement of the development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development. This may include clinical trial implementation, and oversight of all aspects of clinical development working closely with the cross-functions to provide high-quality and timely deliverables.
*This is a remote position. Must be based in the United States.
Excellent Compensation Package, including medical, dental and vision benefits; holidays and paid time off.
Responsibilities:
- Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds
- Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
- Authors components with Medical Director and reviewer of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s)
- Contributes to the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables
- Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
- Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
- Prepare charters and coordinate internal/external committee meetings including presentation preparation
- Participate in the development and review of study plans and serve as a liaison to project teams and CROs
- Provide input for the development of publications
- Perform training at Investigator meetings, CRO/CRA training, SIVs as warranted
Qualifications:
- PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
- Minimum of 5 years of experience in biology research
- Prior oncology/hematology drug development experience is a plus
- Expertise in telomere and telomerase science in oncology a major plus
- Proven skills from working in a project oriented matrixed team environment
- Excellent oral, written and interpersonal (communication) skills
MAIA Biotechnology, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in working at MAIA, please send your CV to careers@maiabiotech.com.