Senior Director, Clinical Science

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.

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.

• 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 planning.
• Lead the development and execution of Clinical Science strategy, priorities, and long‑term organizational objectives
• Co‑lead establishment of a company‑wide clinical trial data management and analytics platform
• Develop future leaders by mentoring Clinical Scientists and associate clinical scientists across program teams, strengthening scientific, strategic, and leadership capabilities across the organization.
• Perform other duties and responsibilities as assigned

• Education:
  
  PhD, PharmD, in a relevant scientific or clinical discipline or equivalent experience.
• 12+ years of clinical research/clinical development experience in the biopharmaceutical or pharmaceutical industry, including significant experience in a clinical science leadership role.
• Demonstrated experience authoring clinical protocols, CSRs, and regulatory submission documents.
• Experience interacting directly with global regulatory agencies (e.g., FDA, EMA) preferred.
• Experience in autoimmune, immunology, or inflammation indications strongly preferred.
• Deep knowledge of clinical trial design, GCP, and global regulatory requirements.
• Strong scientific and clinical data interpretation skills, including familiarity with statistical concepts.
• Proficiency with clinical trial management and data visualization tools.
• Proven ability to lead and influence cross‑functional teams without direct authority.
• Experience mentoring and developing junior scientific staff.
• Sound judgment in escalating and resolving complex scientific…