Senior Director, Clinical Pharmacology

The role

The Senior Director, Clinical Pharmacology provides clinical pharmacology leadership across development programs. This person directs PK/PD strategy, modeling and simulation, and dose-selection activities to inform clinical trial design and regulatory submissions.

What you will do

• Lead clinical pharmacology strategy for assigned programs, including PK/PD study design and dose-selection rationale.
• Direct population PK, exposure-response, and modeling and simulation analyses performed internally or by vendors.
• Author and review clinical pharmacology sections of INDs, NDAs/BLAs, and health authority responses.
• Serve as clinical pharmacology lead on cross-functional program teams, advising on drug-drug interaction and special population studies.
• Represent clinical pharmacology in interactions with health authorities (e.g., FDA/CHMP meetings).
• Provide clinical pharmacology assessments to due diligence and licensing evaluations.
• Oversee clinical pharmacology CRO and modeling vendor relationships and deliverables.
• Perform other duties and responsibilities as assigned

Required qualifications

• PharmD, PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, pharmaceutical sicences, or related discipline required.
• 10+ years of clinical pharmacology experience in pharma/biotech, including leadership of PK/PD strategy across development-stage programs.
• 3+ years of vendor management oversight experience.
• Expertise in population PK/PD modeling, and relevant software (e.g., NONMEM, R).
• Strong knowledge of ICH and FDA/EMA clinical pharmacology guidance.
• Understanding of drug-drug interaction and special population study design.
• Proven ability to lead clinical pharmacology strategy discussions with senior internal and external stakeholders, including regulators.
• Excellent scientific writing and presentation skills for regulatory submissions and health authority interactions.
• Skilled at defending clinical pharmacology strategy directly with health authorities.
• Demonstrated ability to manage external CROs/vendors and coordinate study execution across multiple stakeholders
• Strong project/program management capability, including timeline planning, cross-functional coordination, risk tracking, deliverable management, and issue escalation.
• Ability to communicate scientific and operational issues clearly to cross-functional teams and senior stakeholders.

Nice to have

• Experience in immunology, inflammation, autoimmune disease, immune-mediated diseases, T-cell biology, cell therapy, biologics, gene therapy, or other novel therapeutic modalities

Benefits

• Competitive health and wellness coverage
• Paid time off, public holidays, and additional leave entitlements
• Flexible work arrangements / hybrid schedule

About the company

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.