Senior Director, Clinical Pharmacology

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. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

The Senior Director, Clinical Pharmacology provides clinical pharmacology leadership across development programs, directing PK/PD strategy, modeling and simulation, and dose-selection activities to inform clinical trial design and regulatory submissions. Leads population PK, exposure-response, and other quantitative modeling efforts performed internally or through modeling vendors and translates the resulting insights into dose-selection rationale that shapes protocol design. Serves as the clinical pharmacology voice on cross-functional program teams and represents the function directly with health authorities during meetings and submission reviews. This role requires both technical modeling expertise and the credibility to defend clinical pharmacology strategy in high-stakes regulatory interactions.

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

• 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), including authorship of relevant sections of briefing documents.

• Provide clinical pharmacology assessments to due diligence and licensing evaluations, as applicable.

• Oversee clinical pharmacology CRO and modeling vendor relationships and deliverables.

• Perform other duties and responsibilities as assigned

• Education: 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 with ability to manage and hold CRO/modeling vendors accountable for deliverable quality.

• Experience in immunology, inflammation, autoimmune disease, immune-mediated diseases,