Senior Medical Director, Clinical Development

About The Company
A venture-backed biotechnology organization focused on discovering and developing transformative therapeutics is seeking to expand its clinical development team. The company leverages cutting-edge discovery technologies to advance a growing pipeline of small-molecule programs across a range of high-value disease targets. With a multidisciplinary environment that emphasizes scientific rigor, collaboration, and innovation, the team is dedicated to delivering meaningful medicines for patients with significant unmet needs.

The organization values diverse expertise, open communication, and a fast-paced, mission-driven culture where employees learn from one another and contribute directly to advancing therapeutic programs through preclinical and clinical development.

About The Role
The company is seeking a
Senior Medical Director
to provide strategic leadership in clinical development, including overall program strategy, planning, and execution. This individual will serve as the
Clinical Development Leader (CDL)
for a clinical-stage program and be responsible for designing, implementing, and driving the clinical development plan (CDP). The role involves close partnership with cross-functional teams, participation in regulatory interactions, and engagement with key opinion leaders (KOLs).

The ideal candidate brings strong clinical and scientific judgment, excellent communication skills, and demonstrated leadership in a dynamic biotech environment.

Responsibilities

• Serve as an enterprise leader for program strategy, partnering cross-functionally with clinical operations, regulatory, clinical pharmacology, research, CMC, and other functions to ensure program success.
• Lead the design and execution of robust clinical development plans aligned with the target product profile.
• Guide development teams with innovative, efficient, and scientifically sound approaches to clinical development.
• Design fit-for-purpose clinical trials across all phases; draft protocol synopses, clinical trial protocols, amendments, and supporting documentation.
• Contribute to investigator brochures, clinical study reports, regulatory filings, and publications.
• Provide medical oversight for clinical studies, offering clinical and safety monitoring guidance.
• Ensure alignment with timelines and deliverables through cross-functional collaboration.
• Work with regulatory affairs to develop strategic regulatory plans and lead regulatory engagement efforts.
• Communicate emerging safety or program risks to leadership in a timely manner.
• Provide strategic clinical input to research teams on decisions with significant downstream implications.
• Ensure compliance with ICH, GCP, SOPs, and global regulatory standards.
• Partner with the Chief Medical Officer to ensure organizational scalability of the clinical development function.
• Mentor junior physicians and clinical development professionals.
• Travel to clinical sites, conferences, and regulatory meetings as needed.

Qualifications

• MD or MD/PhD with 5+ years of experience in Clinical Development or related pharmaceutical/biotech role.
• Specialty training or board certification in endocrinology preferred.
• Proven track record developing drugs across multiple therapeutic areas; rare disease experience is a plus.
• Experience with early-through-late stage development, including first-in-human trials and regulatory filings.
• Demonstrated ability to manage complex clinical programs and navigate challenges.
• Strong leadership skills in matrixed, cross-functional environments.
• Expertise in innovative clinical trial design, scientific writing, and implementation of clinical protocols and study reports.
• Experience preparing and leading regulatory submissions and interactions (global preferred).
• Deep understanding of GCP, ICH, and other international regulatory requirements.
• Ability to manage multiple priorities with accuracy and efficiency.
• Excellent communication and presentation skills.
• Thrives in a fast-paced, entrepreneurial biotech setting.

Compensation
The anticipated salary range for this position is
$340,000 – $375,000
, with additional benefits, stock options, and annual performance bonus potential. Actual compensation will depend on experience, skills, and job-related qualifications.