Executive Director, Clinical Science and Clinical Research Operations

Position Summary

Executive Director, Clinical Science and Clinical Research Operations – senior executive who sets the strategic direction for clinical science and operational execution across the endocrine clinical development portfolio, from early development through registration. This leader shapes the Clinical Scientist operating model, establishes enterprise-wide standards, builds organizational capability, drives alignment across cross‑functional teams, and ensures scientific strategy and operational delivery are fully integrated.

• Lead and develop the Clinical Scientist function, including staff, consultants, and Clinical Research Project Coordinator, by building organizational capability, shaping succession pipelines, and driving a high‑performance culture aligned with enterprise priorities.
• Define and evolve the Clinical Scientist operating model, establishing standards, processes, and governance to ensure consistent, scalable execution across all clinical development programs.
• Serve as the senior leader and decision‑maker across Clinical Research and key partner functions (Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Writing), driving alignment on clinical development strategy and resolving cross‑functional trade‑offs impacting quality, timelines, and risk.
• Own clinical data oversight, ensuring clean data, analysis, and interpretation to enable high‑quality medical decision‑making, regulatory submissions, manuscripts, and internal/external presentations.
• Collaborate with Medical Leads and Medical Monitors on clinical data reviews to identify and investigate events of special interest.
• Accountable for proactive partnering with Biometrics and Pharmacovigilance in reviewing periodic data listings (adverse events, protocol deviations, concomitant medications, laboratory abnormalities).
• Establish and oversee a systematic data quality framework across multiple studies, ensuring early signal detection and timely escalation and resolution.
• Represent the organization externally, setting the tone for protocol training and site engagement.
• Drive the scientific execution of key regulatory documents, including IND/CTA/IMPD submissions, protocols and amendments, informed consent forms, clinical study reports, briefing books, safety updates, and responses to Health Authority questions.
• Set direction for clinical documentation standards, overseeing development of study documents including feasibility questionnaires, study plans, eCRFs, eCRF guidelines, and other trial‑specific materials.
• Oversee DSMB/DMC preparation, ensuring high‑quality data presentations that enable independent safety review and informed stopping‑rule decisions.
• Oversee strategic partnerships with CROs, ensuring strong relationships, quality delivery, and alignment with program and company objectives.
• Lead data cleaning activities through database lock (DBL), coordinating across Clinical Operations, Biometrics, and Medical Monitoring to deliver complete, query‑resolved datasets; provide the Medical Lead with clean, analysis‑ready data to support clinical trial decision‑making.
• Lead the development, review, and approval of clinical trial startup materials, ensuring all materials meet regulatory standards and are aligned with program strategy prior to site activation.
• Identify, elevate, and resolve program and portfolio risks in a timely and structured manner; partner with the team to prioritize activities, reallocate resources, and implement risk mitigation plans that protect program timelines and data integrity.
• Drive continuous improvement and transformation initiatives across the Clinical Science team, anticipating future needs and implementing changes that enhance efficiency, quality, and scalability.
• Other duties as assigned.

• Required:
  
  Ph.D., Pharm.
  
  D., MPH, or MS in Biological Sciences, Life Sciences, Pharmacy, or related field; 13+ years of clinical research experience spanning Phase1–3 programs in a pharmaceutical or biotechnology company.
• Minimum 6years in Endocrine therapeutic area and rare disease clinical development, with an established track…