Director, Clinical Development

Role Summary

The Director, Clinical Development is responsible for the development of the company’s drug candidate(s). The role requires a strong understanding of all phases of clinical drug development, including clinical trial management, IND and NDA submissions, medical monitoring, pharmacovigilance, Good Clinical Practice (GCP) principles, and collaboration with Clinical Operations, Biometrics, Regulatory Affairs, Medical Affairs, and external stakeholders.

Responsibilities

• Develop and implement clinical strategies to support the company’s rare disease program(s), ensuring alignment with overall corporate objectives.
• Support the design and execution of clinical development plans, including the planning and hands-on execution of clinical trials.
• Work cooperatively with Clinical Operations, CROs, and external vendors to implement clinical studies (e.g., lead from study start-up through database lock; review and draft start-up documents/study manuals; perform ongoing data review/analyses; and draft and present clinical information to Investigators and advisory panels as required).
• Provide clinical expertise and strategic medical input for clinical deliverables. Clinical deliverables may include, but are not limited to, protocols, statistical analysis plans, regulatory documents/registration dossiers, and scientific publications.
• Support the development of the clinical sections of regulatory documents in support of submissions, including INDs, NDAs, urgent information requests, and other submission packages to global health authorities, as required.
• Function as medical monitor and internal subject matter expert, ensuring the overall safety of drug candidate(s), while supporting pharmacovigilance functions (e.g., IND safety updates, PADERs, PBRERs, Drug Safety Update Reports [DSURs], and other safety updates).
• Actively seek and maintain credible relationships with Key Opinion Leaders (KOLs), Investigators, and patient advocacy groups.
• Other duties commensurate with position and experience, as assigned.

Qualifications

• Board certified/board eligible physician.
• Training and/or experience in pediatric endocrinology desired.
• Demonstrated ability to independently evaluate, interpret and present complex clinical and scientific data.
• Demonstrated ability to critically evaluate complex drug development programs.
• Rare/orphan disease (Prader-Willi syndrome) experience desired.
• Team player with proven leadership experience.
• Demonstrated ability to work within a fast-paced, multi-disciplinary team of peers and outside experts.
• Excellent communication, presentation, and interpersonal skills.