Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area. This role is with a mid-size company and they have a culture that can't be beat. This critical hire will lead the Translational Development team to generate the hypotheses, mechanism-of-action, and pharmacology data that fuel the company pipeline. They are seeking an experienced leader to spearhead efforts to translate innovative therapies safely from research to the clinic and then the marketplace. Are you looking to make a significant impact for patients afflicted with rare diseases and cancer?
The main function of this role is to shape and scale their expanding translational pharmacology function, including translational bioassays and pharmacology/pharmacokinetics. In this role, you will lead a team of managers, scientists and associates responsible for pharmacology/PK analyses and the development and validation of bioanalytical assays for PK, PD and immunogenicity assessments for all programs in the pipeline.
Responsibilities include but are not limited to;
• Apply principles of Clinical Pharmacology to drug development of cell and gene therapies. Will be responsible for strategy, design, execution, analysis, interpretation and reporting of preclinical and clinical pharmacology-related studies. Previous cell & gene therapy experience preferred but not required – see qualifications below.
• Ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exists to support filings for first-in-human administration.
• In collaboration with pharmacometrics and biostatistics groups, lead development of analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize dosing.
• Preparation of regulatory documentation and participation in meetings with regulatory agencies as the Clinical Pharmacology representative.
• Recruitment, development and retention of high-performance personnel.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have an advanced degree (PhD, DVM, or MD) or relevant training in clinical pharmacology, pharmaceutical sciences, or related discipline with 10+ years of experience in building, scaling and integrating preclinical and clinical pharmacology capabilities. Must have a record of significant contributions to INDs/CTAs, Regulatory Agency interactions, BLAs/MAAs, drug approvals, and peer reviewed publications. Experience in T-cell therapeutics (CAR-T, TCR, etc.) and/or cell & gene therapy is preferred but not required. At minimum, qualified candidates must have experience with the development of biotherapeutics. Must be able to demonstrate the ability to build and lead a world-class preclinical and clinical pharmacology function, including extensive outsourcing relationships and organizational growth and design strategy.
Must be authorized to work in the US indefinitely to be considered. Relocation assistance available for qualified candidates.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.