Role Overview for VP, Clinical Pharmacology with a Gene Therapy Company – Philadelphia, PA
JRG Partners is proud to represent a pioneering, clinical-stage gene therapy company at the forefront of developing curative treatments for rare and life-threatening diseases. Based in the vibrant biopharmaceutical hub of Philadelphia, PA, our client is seeking a visionary and strategic leader to join their executive team as the Vice President, Clinical Pharmacology. This is a rare opportunity to shape the future of medicine and build a world-class clinical pharmacology function from the ground up.
The Vice President, Clinical Pharmacology will serve as the company’s foremost expert on pharmacokinetics (PK), pharmacodynamics (PD), and Modeling & Simulation (M&S). This individual will be a key member of the clinical development leadership team, providing critical strategic direction for all programs, from preclinical stages through to BLA submission and post-marketing activities. You will be responsible for defining and executing the clinical pharmacology strategy that supports the optimal development and regulatory approval of a novel pipeline of gene therapies.
This executive role demands a unique blend of deep scientific expertise, strategic acumen, and inspirational leadership. You will be instrumental in key decision-making processes, including first-in-human dose selection, dose-escalation strategies, proof-of-concept determination, and pediatric study planning. Your insights will directly influence the speed and success of clinical trials, ensuring that these potentially life-changing therapies reach patients in need as safely and efficiently as possible. You will build and mentor a high-performing team, foster a culture of scientific rigor and innovation, and represent the company before regulatory agencies and the broader scientific community. This position offers significant visibility and the chance to make a profound impact on both the company’s trajectory and the lives of patients worldwide.
Key Responsibilities of VP, Clinical Pharmacology with a Gene Therapy Company – Philadelphia, PA
Strategic Leadership & Vision
Develop and implement the overarching clinical pharmacology, PK/PD, and M&S strategy across the entire gene therapy portfolio. Act as the primary thought leader, providing expert guidance to the executive team, board of directors, and cross-functional project teams.
Clinical Program Development
Provide expert input on all clinical development plans (CDPs). Design, oversee, and interpret results from all clinical pharmacology studies, ensuring they are scientifically robust and strategically aligned with program goals. Establish the scientific rationale for dose selection and regimen for all clinical trials, from Phase 1 to Phase 3.
Modeling & Simulation (M&S)
Champion the use of advanced M&S techniques (e.g., PK/PD modeling, population PK, exposure-response analysis, PBPK) to inform study design, optimize dosing strategies, predict clinical outcomes, and support regulatory filings. Build and lead the internal M&S capability or effectively manage external vendors.
Regulatory Strategy & Interaction
Lead the development and authoring of all clinical pharmacology-related sections of global regulatory submissions, including INDs, CTAs, BLAs, and MAAs. Serve as the clinical pharmacology expert in key meetings with global health authorities, such as the FDA and EMA, and prepare robust responses to their inquiries. Ensure all strategies are compliant with current FDA guidelines for gene therapy products and other international regulations.
Cross-Functional Collaboration
Foster a highly collaborative environment by working closely with leaders in Clinical Development, Research, Bioanalytical Sciences, Biostatistics, CMC, and Regulatory Affairs. Ensure seamless integration of clinical pharmacology principles throughout the drug development lifecycle.
Team Building & Mentorship
Recruit, lead, and develop a team of talented clinical pharmacologists and M&S scientists. Provide scientific guidance, mentorship, and career development opportunities to build a world-class function recognized for its excellence and impact.
Scientific Excellence & Communication
Stay abreast of the latest scientific and regulatory advancements in clinical pharmacology, particularly within the cell and gene therapy space. Represent the company by publishing in peer-reviewed journals and presenting at major scientific conferences, enhancing the company’s scientific reputation.
Vendor & Budget Management
Oversee the selection and management of CROs and other external vendors for bioanalytical and PK/PD analysis. Develop and manage the departmental budget, ensuring efficient allocation of resources to meet strategic objectives.
Requirements for the VP, Clinical Pharmacology with a Gene Therapy Company – Philadelphia, PA
Educational Background
An advanced degree (PhD, PharmD, or MD) in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related scientific discipline is required.
Professional Experience
A minimum of 15 years of progressive experience in the biopharmaceutical industry, with at least 10 years dedicated to clinical pharmacology and a proven track record of operating at a senior leadership level (Director, Senior Director, or VP).
Gene Therapy/Biologics Expertise
Significant experience with the development of biologics is essential. Direct, hands-on experience with cell or gene therapies (e.g., AAV vectors) is strongly preferred and will be a key differentiator.
Regulatory Expertise
Extensive, first-hand experience in preparing clinical pharmacology sections of major regulatory submissions (INDs, BLAs) and a successful track record of interactions with global health authorities (FDA, EMA).
Leadership & Management
Demonstrated success in building, leading, and mentoring high-performing teams. Must possess executive presence and the ability to influence and align stakeholders across all levels of the organization.
Technical Proficiency
Deep and broad expertise in modern clinical pharmacology principles, including advanced PK/PD analysis, population PK, and the strategic application of modeling and simulation (e.g., using software like NONMEM, R, Phoenix WinNonlin).
Strategic Thinking
Ability to translate complex scientific concepts into clear, actionable development strategies. A forward-thinking mindset with the capacity to anticipate challenges and proactively develop solutions.
Communication Skills
Exceptional written and verbal communication skills, with the ability to clearly articulate complex data and strategies to diverse audiences, from scientific experts to board members.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package. They believe in rewarding employees for their contributions to advancing science and helping patients.
Competitive Salary and Bonus
A highly attractive base salary and an annual performance-based bonus structure designed to reward success.
Significant Equity
A meaningful equity stake (stock options/RSUs) in the company, providing the opportunity to share in the long-term success you help create.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents with low employee contributions.
Retirement Savings
A 401(k) plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick days, and company holidays, to support a healthy work-life balance.
Professional Development
A substantial budget for attending conferences, workshops, and continuing education courses to foster your growth and keep you at the cutting edge of the field.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates moving to the Philadelphia area.
Wellness Programs
Company-sponsored wellness initiatives, including gym membership reimbursements and mental health resources.
How to Apply
This is a retained search conducted exclusively by JRG Partners. If you are a visionary leader in clinical pharmacology with a passion for gene therapy and a desire to build something truly impactful, we encourage you to apply.
To be considered for this pivotal role, please submit your CV and a cover letter outlining your qualifications and interest. Confidential inquiries are welcome. For more information about our expertise in this sector, please visit our Life Sciences Recruiting practice area page. JRG Partners and our client are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees.
