Senior Director, Clinical Pharmacology

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role: 

As Generate:Biomedicines advances multiple programs into late-stage development, we are seeking a Senior Director of Clinical Pharmacology and Pharmacometrics to lead strategy and execution across key Phase 2 and 3 studies. Reporting to the Head of Clinical Pharmacology, this leader will provide scientific and operational direction for pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response strategies across our portfolio, with an emphasis on respiratory and immunology indications.

This role will partner closely with Clinical Development, Biostatistics, Regulatory, and Translational Sciences to ensure high-quality clinical pharmacology deliverables that enable data-driven decisions and successful regulatory interactions.

Here's how you will contribute:

• Serve as the clinical pharmacology and pharmacometrics lead on late-stage programs, driving PK/PD and exposure-response strategy from early clinical studies through pivotal trials and submissions.
• Design and oversee modeling and simulation plans to inform dose selection, trial design, and regulatory filings.
• Author and review key clinical pharmacology and pharmacometrics sections of INDs, BLAs, and related documents; participate in regulatory interactions as functional expert.
• Collaborate with cross-functional teams to integrate clinical pharmacology and pharmacometrics principles into clinical study designs, endpoints, and statistical approaches.
• Contribute to pediatric strategy development and submissions.
• Support the Head of Clinical Pharmacology in building scalable processes, standards, and systems that enable late-stage and global development.

Leadership Responsibilities

• Set clear expectations for scientific rigor, data quality, and accountability.
• Foster an inclusive, high-performing team culture that emphasizes transparency, adaptability, and collaboration.
• Develop team members through mentorship, coaching, and stretch opportunities.
• Partner effectively across functions to ensure timely delivery of critical program milestones.

The Ideal Candidate will have:

• 10–12+ years of experience in clinical pharmacology and pharmacometrics within biotech or pharma, including significant late-stage (Phase 2/3) and regulatory submission experience.
• Demonstrated success contributing to regulatory agency interactions (FDA, EMA, PMDA, or NMPA) on clinical pharmacology and pharmacometrics deliverables.
• Strong background in PK/PD modeling and simulation and demonstrated ability to translate quantitative findings into clinical strategy.
• Experience supporting respiratory or immunology indications preferred.
• Excellent communication skills, with the ability to present complex data to diverse audiences.
• Proven experience building effective cross-functional partnerships

Education

PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences, or related field.

Nice to Have (Optional)

• Prior experience in a fast-growing or first-to-market biotech environment.
• Familiarity with combination products or complex biologics.
• Working knowledge of bioanalytical methods and data review.

Why Join Us?

Join Generate:Biomedicines and play a key leadership role in shaping clinical pharmacology strategy as we enter late-stage development. You’ll work alongside world-class scientists translating the p