Executive 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 transitions into late-stage development and prepares for global regulatory interactions, we are seeking an Executive Director of Clinical Pharmacology to lead strategy and execution for global Ph2/3 studies. Reporting to the Head of Clinical Pharmacology and working closely with the Head of Clinical Development, this role will drive the clinical pharmacology vision across our pipeline, with a strong focus on respiratory indications and global regulatory alignment.

Here's how you will contribute:

• Act as the subject matter expert for regulatory agency interactions on clinical pharmacology topics, including INDs, BLAs, and pediatric plans.
• Design and oversee modeling and simulation efforts to support decision-making and regulatory submissions.
• Lead the development of global PK, PK/PD, exposure-response related strategies, ensuring alignment with expectations in key regions including the US, EU, China, and Japan.
• Collaborate closely with Clinical Development, Biostatistics, Regulatory, and Translational Sciences to optimize clinical trial design and endpoints.
• Drive pediatric strategy including iPSP/PSP development and regulatory engagement.
• Guide bioanalytical strategy and ensure data integrity across internal and outsourced activities.
• Provide clinical pharmacology oversight across development stages

Leadership Responsibilities

• Build and lead a high-performing clinical pharmacology function with strong cross-functional influence.
• Mentor and develop scientists, fostering scientific excellence, accountability, and collaborative innovation.
• Champion transparency, adaptability, and urgency to meet program and regulatory milestones.

The Ideal Candidate will have:

• 12+ years of experience in clinical pharmacology within biotech or pharma, including late-stage development and global regulatory interactions.
• Proven track record leading clinical pharmacology deliverables in regulatory agency engagements, including FDA, EMA, PMDA, and NMPA.
• Strong background in pediatric development and regulatory submission planning.
• Deep expertise in PK/PD modeling and simulation, with demonstrated impact on program strategy.
• Experience supporting respiratory indications preferred.
• Excellent written and verbal communication skills, including authoring and defending regulatory documents.

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 critical role in bringing pioneering respiratory medicines to patients worldwide. You’ll shape global clinical pharmacology strategy and help define the path for first-in-class medicines powered by generative biology.

Equal Opportunity Employer Statement
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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