Senior Medical Director, Clinical Development

Role Summary

Senior Medical Director, Clinical Development role leading a late-stage, pivotal program with potential to expand to additional assets. Responsible for medical monitoring of assigned clinical trials, development and execution of the Clinical Development Plan, including study design and interpretation of study data. Works within a multi-disciplinary matrix team to ensure clinical and scientific issues are appropriately considered in studies and overall development plans; may be involved in translational activities, operationalizing studies, real-time data monitoring, and issue identification. Interacts with internal functions and with external stakeholders including the global medical community, regulatory authorities, alliance partners, and vendors. Reports to the Senior VP of Clinical Development and may lead a small team of clinical scientists and physicians.

Responsibilities

• Provides medical monitoring to assigned clinical trials in the arenas of serious endocrine conditions, neurogenerative and/or rare disease
• Provides clinical development leadership for programs that integrate extensive knowledge in clinical science with inputs from the global medical and patient communities.
• Works closely with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans.
• Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid Clinical Development Plan (CDP).
• Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels.
• Develops and maintains relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and Contract Research Organizations (CROs).
• Acts as the primary Clinical Development interface with internal stake holders as well as external subject matter experts and alliance partners for the assigned programs.
• Contributes to specific Business Development activities and various organizational initiatives in Clinical Development.

Qualifications

• MD required
• Experience with late-stage clinical development and drug development in rare diseases strongly preferred
• 4+ years of experience in leading clinical development programs in the biotechnology/pharmaceutical industry with a proven record of achievements.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment.
• Ability to lead directly and by influence, including strong interpersonal, problem solving, conflict resolution and analytical skills in a matrix environment.
• Excellent communication skills (oral and written) and organizational skills.
• Ability to travel internationally and domestically

Additional Requirements

• Remote work opportunities within the United States; must have access to a suitable remote working environment (privacy, reliable internet, phone, and video conferencing).
• Travel to Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• Ability to travel internationally and domestically.