Role Overview for Chief Medical Officer (CMO) with a Biopharma Start-up – Cambridge, MA
JRG Partners has been exclusively retained to identify a visionary and experienced Chief Medical Officer (CMO) for our client, a well-funded, clinical-stage biopharmaceutical startup poised to revolutionize the treatment of complex diseases. Located in the heart of the global biotechnology hub in Cambridge, MA, our client is developing a pipeline of first-in-class therapeutics based on a proprietary platform technology. This is a rare opportunity to join a dynamic executive team and shape the future of a company with the potential for transformative patient impact.
The Chief Medical Officer will be the key strategic leader responsible for the entire clinical development lifecycle, from translational medicine and first-in-human studies through to global regulatory submissions and commercial launch. As a core member of the executive leadership team, the CMO will provide critical medical and scientific guidance that will influence corporate strategy, investor relations, and business development activities. You will be instrumental in building a world-class clinical organization, fostering a culture of scientific excellence, and driving the clinical programs forward with urgency and precision. This role requires a hands-on leader who is as comfortable designing a Phase 1 trial as they are presenting to the board of directors or engaging with the FDA. If you are an entrepreneurial physician-scientist with a proven track record of drug development success and a passion for building something truly meaningful from the ground up, we invite you to consider this career-defining role.
Key Responsibilities of Chief Medical Officer (CMO) with a Biopharma Start-up – Cambridge, MA
The CMO will assume broad responsibility for the company’s clinical development, medical affairs, and drug safety functions. This includes, but is not limited to, the following:
Clinical Development Strategy & Execution
- Architect and implement the overarching clinical development strategy for the company’s entire portfolio, ensuring alignment with corporate goals and commercial objectives.
- Provide hands-on leadership in the design, execution, and interpretation of all clinical trials, from Phase I to pivotal Phase III studies.
- Author, review, and approve key clinical and regulatory documents, including clinical trial protocols, Investigator’s Brochures (IBs), clinical study reports (CSRs), and publications.
- Oversee all clinical operations activities, including site selection, patient recruitment, data management, and vendor/CRO management, to ensure trials are conducted on time, within budget, and in full compliance.
Regulatory Leadership
- Serve as the primary medical liaison with global regulatory authorities, including the FDA, EMA, and other agencies.
- Lead the strategy, preparation, and submission of all regulatory filings, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs).
- Ensure all clinical activities are conducted in strict adherence to Good Clinical Practice (GCP), ICH guidelines, and other applicable regulations.
- Proactively identify and mitigate potential regulatory risks to the clinical programs.
Medical & Scientific Leadership
- Serve as the company’s lead medical expert, providing deep scientific and clinical insights to internal teams, the Board of Directors, investors, and external partners.
- Establish and maintain strong, collaborative relationships with Key Opinion Leaders (KOLs), principal investigators, and advisory boards to inform clinical strategy and trial design.
- Represent the company and present clinical data at major scientific conferences, investor meetings, and partnering discussions.
- Stay at the forefront of scientific and medical advancements within the relevant therapeutic areas to ensure the company’s strategy remains innovative and competitive.
Pharmacovigilance & Patient Safety
- Establish and oversee a robust pharmacovigilance and drug safety function to ensure the highest standards of patient safety across all clinical programs.
- Lead the safety management team, including the ongoing review and analysis of safety data, signal detection, and risk management planning.
- Ensure timely and accurate safety reporting to all regulatory authorities.
Executive & Organizational Leadership
- As a member of the executive team, contribute significantly to the overall corporate strategy, long-range planning, and fundraising efforts.
- Build, mentor, and lead a high-performing team of professionals across clinical development, clinical operations, medical affairs, and drug safety.
- Foster a culture of scientific rigor, collaboration, accountability, and urgency within the clinical organization.
- Collaborate effectively with cross-functional leaders in Research, CMC, Finance, and Business Development to achieve corporate milestones.
Requirements for the Chief Medical Officer (CMO) with a Biopharma Start-up – Cambridge, MA
The ideal candidate will be a strategic and results-oriented physician-scientist with extensive experience leading clinical development in the biopharmaceutical industry. This individual must be capable of operating at both a strategic and a tactical level in a fast-paced, entrepreneurial environment.
Education & Credentials
- An M.D. is required. An M.D./Ph.D. is highly preferred.
- Board certification in a relevant medical specialty (e.g., Oncology, Hematology, Immunology, Neurology) is strongly desired.
- Must have and maintain an active medical license.
Professional Experience
- A minimum of 15 years of progressive experience in clinical research and drug development within the biopharmaceutical industry.
- A proven track record of successfully leading clinical programs from early-stage (IND filing) through to late-stage development and regulatory approval (NDA/BLA).
- Demonstrable experience designing and implementing innovative and efficient clinical trial protocols.
- Significant, direct experience leading interactions and negotiations with the FDA and other major global health authorities is essential.
- Prior experience in a small biotech or startup environment is highly advantageous. The ability to thrive with ambiguity and adapt to rapid change is critical.
- Experience in oncology, immunology, or rare diseases is a significant plus.
Skills & Competencies
- Strategic Vision: Ability to think critically about the long-term clinical and regulatory landscape and translate that vision into actionable plans.
Leadership
Proven ability to build, lead, and inspire high-performing teams. A natural mentor who invests in the development of their people.
Communication
Exceptional written, verbal, and presentation skills. Ability to articulate complex scientific and clinical concepts clearly to a wide range of audiences, from scientists to investors.
Influence
Strong interpersonal skills and the ability to build consensus and influence key stakeholders both internally and externally.
Problem-Solving
A creative and analytical problem-solver who can navigate the complex challenges inherent in drug development.
Integrity
Unquestionable personal and professional integrity, with a deep commitment to ethical conduct and patient well-being.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive and comprehensive compensation package. This includes:
Competitive Base Salary
An attractive base salary commensurate with executive-level experience and market standards.
Annual Performance Bonus
A generous annual bonus target based on the achievement of individual and corporate goals.
Significant Equity Stake
A substantial stock option grant, providing the opportunity for significant wealth creation and a vested interest in the company’s long-term success.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A 401(k) plan with a competitive company match to help you plan for your future.
Generous Paid Time Off
A flexible and generous PTO policy, including vacation, sick leave, and company holidays.
Professional Development
Support for attending scientific conferences, continuing education, and other professional growth opportunities.
Impactful Work
The unparalleled opportunity to be a foundational leader in a company developing potentially life-saving medicines for patients in need.
How to Apply
This is a confidential search being conducted exclusively by JRG Partners. To be considered for this pivotal leadership role, please submit your CV and a cover letter outlining your qualifications and interest in the position. All inquiries and applications will be handled with the utmost discretion.
JRG Partners is a leader in retained executive search for the life sciences industry. To learn more about our expertise in this area, please visit our Life Sciences Executive Search practice page. We look forward to reviewing your application and discussing this exciting opportunity with you.
