Role Overview for VP, Clinical Affairs with a Biopharma Start-up – Cambridge, MA
Are you a visionary clinical leader ready to make a transformative impact in the field of oncology? JRG Partners is exclusively representing a well-funded, clinical-stage biopharmaceutical start-up at the forefront of developing novel, first-in-class therapeutics. Located in the vibrant biotechnology ecosystem of Cambridge, MA, our client is driven by a mission to address significant unmet medical needs for patients with life-threatening diseases. We are seeking a dynamic and experienced Vice President of Clinical Affairs to provide the strategic and operational leadership necessary to advance their promising pipeline through clinical development and towards regulatory approval.
Reporting directly to the Chief Medical Officer (CMO), the VP of Clinical Affairs will be a pivotal member of the senior leadership team. This role carries the ultimate responsibility for the design, execution, and interpretation of all clinical trials. You will be instrumental in shaping the company’s clinical future, building a world-class clinical affairs organization, and navigating the complex regulatory landscape. This is a unique opportunity to join an agile, science-driven, and highly collaborative organization where your contributions will directly influence the company’s trajectory and, most importantly, the lives of patients. If you thrive in a fast-paced environment and possess a deep passion for bringing innovative medicines from the lab to the clinic, we invite you to apply.
Key Responsibilities of VP, Clinical Affairs with a Biopharma Start-up – Cambridge, MA
Clinical Development Strategy
Architect and implement the overarching clinical development strategy for the company’s entire portfolio. You will be responsible for creating robust Clinical Development Plans (CDPs), defining Target Product Profiles (TPPs), and ensuring that all clinical activities are strategically aligned with corporate objectives and commercial goals.
Clinical Trial Execution and Oversight
Provide senior-level oversight for all phases of clinical trials (Phase I-III), from protocol design and feasibility to final study report. This includes managing site selection, optimizing patient recruitment strategies, and ensuring that all trials are conducted on schedule, within budget, and in full compliance with regulatory standards.
Regulatory Leadership
Serve as the primary clinical point of contact with global regulatory agencies, including the FDA and EMA. You will lead the clinical strategy for regulatory interactions, oversee the preparation of key clinical sections of regulatory submissions (e.g., INDs, NDAs, BLAs), and represent the company at critical regulatory meetings.
Team Leadership and Development
Build, lead, mentor, and inspire a high-performing clinical affairs team encompassing Clinical Operations, Data Management, Biostatistics, and Medical Writing. You will foster a culture of scientific rigor, accountability, innovation, and collaboration, ensuring the team is equipped to meet current and future challenges.
Vendor and CRO Management
Lead the selection, negotiation, and management of Contract Research Organizations (CROs), central laboratories, and other clinical trial vendors. You will establish strong partnerships and implement rigorous oversight mechanisms to ensure the delivery of high-quality data and services.
Data Integrity and Interpretation
Uphold the highest standards of data integrity across all clinical programs. You will oversee the collection, analysis, and interpretation of clinical trial data in collaboration with biostatistics, ensuring that data is clean, accurate, and suitable for regulatory submission and strategic decision-making.
Scientific and Medical Communication
Collaborate closely with Medical Affairs to develop and execute a comprehensive publication and presentation strategy. You will engage with Key Opinion Leaders (KOLs), present pivotal clinical data at major scientific conferences, and contribute to peer-reviewed publications.
Budgetary and Resource Management
Develop, forecast, and manage the multi-million dollar clinical program budget with a high degree of accuracy. You will be responsible for prudent resource allocation, financial planning, and ensuring operational efficiency across all clinical activities.
Cross-Functional Partnership
Act as a key collaborative partner to other functional areas, including Research & Development, CMC, Regulatory Affairs, and Commercial teams. You will ensure seamless integration of clinical development activities with the broader product development strategy.
Pharmacovigilance and Safety Oversight
Establish and oversee robust safety monitoring and pharmacovigilance processes for all clinical trials. You will work closely with the drug safety team to ensure the well-being of trial participants and maintain compliance with all global safety reporting requirements.
Requirements for the VP, Clinical Affairs with a Biopharma Start-up – Cambridge, MA
Educational Background
An advanced degree is required. An MD is strongly preferred. A PhD or PharmD with extensive and directly relevant oncology clinical development leadership experience will be considered.
Professional Experience
A minimum of 15+ years of progressive experience in clinical development within the biotechnology or pharmaceutical industry, with at least 7 years in a senior leadership capacity (e.g., Senior Director, Executive Director, VP). Deep experience in oncology is essential.
Proven Track Record
Demonstrated success in leading clinical programs from early-stage development (IND) through to successful marketing authorization (NDA/BLA approval). Experience managing multiple programs simultaneously is highly valued.
Regulatory Expertise
Extensive, hands-on experience interacting with global regulatory authorities, particularly the FDA and EMA, is required. Must have a proven ability to successfully negotiate with and influence regulatory bodies.
Leadership and Management Skills
Exceptional leadership qualities with a demonstrated ability to build, develop, and motivate high-performing, cross-functional teams in a fast-paced startup environment. A player-coach mentality is essential.
Technical and Scientific Acumen
A strong scientific foundation and a comprehensive understanding of the entire drug development process, including innovative clinical study design, biostatistics, data management, and clinical operations. Expert knowledge of Good Clinical Practice (GCP) guidelines, ICH regulations, and other relevant global standards.
Strategic and Analytical Mindset
Superior strategic thinking, critical analysis, and problem-solving skills. The ability to translate complex scientific and clinical data into actionable strategies and to make sound decisions in the face of ambiguity.
Communication and Interpersonal Skills
Outstanding written and verbal communication skills. The ability to articulate a clear clinical vision and effectively present complex information to a wide range of audiences, including executive leadership, board members, investors, and regulatory authorities.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive and comprehensive benefits package designed to support the well-being and professional growth of their employees.
Competitive Compensation Package
A highly competitive base salary, an aggressive annual performance-based bonus, and a substantial equity stake in the company, providing a significant opportunity for financial reward.
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance for you and your dependents with low employee contributions, alongside wellness programs, and Health Savings (HSA) and Flexible Spending (FSA) accounts.
Retirement Planning
A robust 401(k) retirement savings plan with a generous company matching contribution to help you achieve your long-term financial goals.
Work-Life Balance
A generous and flexible paid time off (PTO) policy, including vacation, sick leave, and numerous company-paid holidays, to ensure you have ample time to rest and recharge.
Career Growth and Development
A commitment to your professional growth with ample opportunities for development, including support for attending major scientific conferences, leadership training programs, and tuition reimbursement.
Inspiring Work Environment
A state-of-the-art office and lab space located in the vibrant heart of Cambridge’s biotechnology hub, designed to foster innovation, collaboration, and scientific discovery.
Onsite Amenities and Perks
Enjoy daily catered lunches, a fully stocked kitchen with a wide variety of snacks and beverages, commuter benefits, and regular team-building events and social gatherings.
How to Apply
- Interested candidates are encouraged to apply for this exceptional opportunity to shape the future of oncology treatment and build a legacy in a promising biopharma company.
- JRG Partners is proud to be the exclusive recruitment partner for this critical leadership search. For a confidential discussion and to submit your application, please connect with our dedicated Life Sciences and Pharmaceutical recruiting team.
- Our client is an equal opportunity employer and values diversity, equity, and inclusion. They do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. All qualified applicants will receive consideration for employment.
