Provides strategic medical leadership and oversight for assigned clinical programs, including late-stage and pivotal trials.
Leads development and execution of Clinical Development Plans (CDPs), integrating clinical, scientific, regulatory, and commercial considerations.
Drives study design, protocol development, and interpretation of complex clinical data to inform key program decisions.
Serves as a core member of cross-functional program teams, influencing strategy and ensuring alignment across disciplines.
Provides senior-level medical monitoring and guidance, ensuring patient safety, data integrity, and high-quality trial execution.
Leads interactions with external stakeholders including key opinion leaders, investigators, regulatory agencies, and alliance partners.
Oversees preparation of key program documents including protocols, investigator brochures, clinical study reports, regulatory submissions, and publications.
Mentors and provides scientific guidance to junior team members, including Medical Directors and Clinical Scientists.
Identifies and implements process improvements and best practices within Clinical Development.

MD required
Significant experience in late-stage clinical development and drug development in biotech/pharmaceutical industry; rare disease experience strongly preferred
Typically 5+ years of experience leading clinical development programs with demonstrated impact on program strategy and execution
Demonstrated ability to collaborate with cross-functional teams and influence without authority in a matrix environment
Strong strategic thinking, problem-solving, and decision-making skills
Proven ability to interpret complex clinical data and translate insights into actionable strategies
Excellent communication and leadership skills, with experience interacting with senior stakeholders and external experts
Experience mentoring or leading team members preferred
Ability to travel internationally and domestically.

Senior Medical Director, Clinical Development

Key skills