Role Overview for VP, Clinical Pharmacology with a Rare Disease Biotech – Cambridge, MA
JRG Partners is proud to represent a pioneering, clinical-stage biotechnology company at the forefront of developing life-changing therapies for patients with rare and ultra-rare diseases. Located in the heart of the global biotech hub in Cambridge, MA, our client is driven by a mission to translate groundbreaking science into tangible hope for underserved patient populations. We are seeking a visionary and strategic leader to join their executive team as the Vice President, Clinical Pharmacology.
This is a paramount leadership role, reporting directly to the Chief Medical Officer, with the responsibility for building, leading, and providing strategic direction for the entire Clinical Pharmacology function. The successful candidate will be the organization’s foremost expert on pharmacokinetics (PK), pharmacodynamics (PD), and quantitative pharmacology. You will play a pivotal role in shaping the development strategy for a diverse pipeline of innovative assets, from first-in-human studies through to regulatory submission and post-marketing commitments. This position offers a unique opportunity to make a transformative impact on the lives of patients by ensuring that novel medicines are developed with optimal dosing and a deep understanding of their exposure-response relationships. You will be instrumental in guiding critical decisions, interacting with global regulatory bodies, and mentoring a team of dedicated scientists in a dynamic, fast-paced, and collaborative environment.
Key Responsibilities of VP, Clinical Pharmacology with a Rare Disease Biotech – Cambridge, MA
The Vice President, Clinical Pharmacology will be accountable for the comprehensive strategy and execution of all clinical pharmacology and pharmacometrics activities across the portfolio. Key responsibilities include:
Strategic Leadership and Vision
Develop and execute the overarching clinical pharmacology and pharmacometrics strategy for all development programs, ensuring alignment with corporate goals and clinical development plans. Serve as the primary subject matter expert on the senior leadership team, providing critical insights that shape go/no-go decisions, trial designs, and overall portfolio strategy.
Program Oversight and Execution
Provide scientific and technical leadership for the design, analysis, interpretation, and reporting of all clinical pharmacology studies. This includes overseeing Phase 1 studies (e.g., SAD/MAD, DDI, BA/BE, special populations) and ensuring the integration of clinical pharmacology principles throughout all phases of clinical development (Phase 1-4).
Quantitative Pharmacology Leadership
Champion the use of advanced modeling and simulation (M&S) techniques to optimize drug development. Oversee the development and application of pharmacokinetic/pharmacodynamic (PK/PD), physiologically-based pharmacokinetic (PBPK), and exposure-response models to inform dose selection, predict clinical outcomes, and support regulatory filings.
Regulatory Strategy and Interaction
Lead the development and authoring of all clinical pharmacology-related sections of global regulatory submissions, including INDs, CTAs, NDAs, BLAs, and MAAs. Serve as the lead representative for the function in meetings and negotiations with global health authorities such as the FDA, EMA, and PMDA.
Cross-Functional Collaboration
Foster a highly collaborative environment, working seamlessly with key partners in Clinical Development, Biostatistics, Nonclinical Development, Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC), and Commercial teams to ensure integrated and efficient drug development.
Team Development and Mentorship
Recruit, lead, and mentor a world-class team of clinical pharmacologists and pharmacometricians. Cultivate a culture of scientific excellence, innovation, accountability, and continuous learning within the department.
Scientific Innovation and External Presence
Stay abreast of the latest scientific and regulatory developments in clinical pharmacology and quantitative drug development. Drive the adoption of innovative methodologies and technologies to enhance efficiency and decision-making. Represent the company at scientific conferences, in publications, and through interactions with key opinion leaders.
Vendor and Budget Management
Oversee the selection and management of contract research organizations (CROs) and other external vendors for clinical pharmacology activities. Develop and manage the departmental budget, ensuring optimal allocation of resources to meet program timelines and objectives.
Requirements for the VP, Clinical Pharmacology with a Rare Disease Biotech – Cambridge, MA
The ideal candidate will be a seasoned leader with a proven track record of success in the biopharmaceutical industry. We are looking for an individual who combines deep scientific expertise with exceptional strategic thinking and leadership capabilities.
Educational Background
An advanced degree (PhD, PharmD, or MD) in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacokinetics, or a related scientific discipline is required.
Professional Experience
A minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, with at least 8-10 years dedicated to a leadership role in clinical pharmacology and pharmacometrics.
Therapeutic Area Expertise
Direct experience in rare diseases is strongly preferred. Experience across multiple therapeutic areas and drug modalities (e.g., small molecules, biologics, gene therapy, oligonucleotides) is highly advantageous.
Technical and Scientific Acumen
Demonstrated mastery of PK/PD principles, M&S methodologies, and their application in drug development. Hands-on experience with industry-standard software (e.g., NONMEM, R, Phoenix WinNonlin, Simcyp) is expected.
Regulatory Expertise
Extensive experience in preparing regulatory documentation and a proven track record of successful interactions with global health authorities. A deep understanding of global regulatory guidelines and expectations is essential.
Leadership and Influence
Proven ability to build and lead high-performing teams. Must possess outstanding communication, presentation, and interpersonal skills, with the ability to influence and align stakeholders across all levels of the organization.
Strategic Mindset
Strong strategic and analytical thinking skills, with the ability to integrate complex scientific and clinical data to make informed decisions and guide development strategy.
Adaptability
Thrives in a fast-paced, innovative, and results-oriented biotech environment. Must be able to manage multiple projects and priorities simultaneously while maintaining a high standard of quality.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive and comprehensive compensation and benefits package. As a key member of the executive team, you can expect:
- A competitive base salary commensurate with experience and role scope.
- An attractive annual executive bonus plan based on individual and company performance.
- A significant equity package, including stock options, providing a meaningful stake in the company’s long-term success.
- Comprehensive health, dental, and vision insurance for you and your eligible dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- Generous paid time off (PTO), including vacation, sick leave, and paid company holidays.
- Support for professional development, including attendance at major scientific conferences and continuing education opportunities.
- Relocation assistance for qualified candidates.
- The opportunity to work within a passionate, mission-driven culture dedicated to making a profound difference for patients with rare diseases.
How to Apply
This is an exclusive search being conducted by JRG Partners. If you are a visionary leader in clinical pharmacology with a passion for rare diseases and a desire to build something truly impactful, we encourage you to apply. To be considered for this career-defining opportunity, please submit your resume and a cover letter detailing your qualifications.
JRG Partners specializes in connecting exceptional talent with leading organizations in the life sciences sector.We look forward to reviewing your application.
