Senior Director, Clinical Science
Beeline Medicines
- Location
- Boston, Massachusetts, United States
- Work model
- On-Site
- Level
- Staff
- Salary
- $266k/yr
- Posted
- 2h ago
Skills
About this role
About Beeline Medicines
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.
Job Summary
The Senior Director, Clinical Science provides senior scientific and strategic leadership for the design, execution, and interpretation of clinical trials across one or more therapeutic programs. Acting as a key scientific expert and thought partner to program and functional leadership, this individual shapes clinical development strategy from early-phase proof-of-concept through late-stage registration and lifecycle management. The role requires close, ongoing collaboration with Biostatistics, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and external investigators and key opinion leaders to ensure that trial designs are scientifically sound, operationally feasible, and aligned with evolving regulatory expectations. The Senior Director is expected to exercise independent scientific judgment on complex, ambiguous problems, represent the organization credibly in front of regulatory authorities and scientific advisory boards, and mentor and develop junior clinical scientists, building both the technical depth and strategic thinking of the broader clinical science function.
Work Arrangement & Location
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.
Essential Duties and Responsibilities
• Serve as the senior clinical/scientific lead on cross-functional study teams, providing scientific direction for protocol design, endpoint selection, and data interpretation.
• Author and critically review clinical study protocols, statistical analysis plans, clinical study reports, and regulatory submission documents (e.g., IND/NDA/BLA sections, briefing documents).
• Partner with Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs to ensure scientifically sound and operationally feasible trial designs.
• Support the design and execution of multiple clinical studies across the development plan
• Study Medical Manager responsibilities from setup through CSR completion, including CRF design, study start-up activities, enrollment monitoring, and patient profile reviews
• Lead the clinical interpretation of emerging safety and efficacy data, including ongoing monitoring of trial data and contribution to Data Safety Monitoring Board materials.
• Represent clinical science in interactions with regulatory authorities, key opinion leaders, and external scientific advisory boards.
• Contribute to the design and execution of clinical development strategy, including lifecycle management and indication expansion