Senior Medical Director, Clinical Development
Location: Boston, MA, USA (Remote, candidate must be East Coast)
Position Overview
Are you ready to lead transformative oncology programs in a global, innovative environment? As a Senior Medical Director, Clinical Development, you will play a pivotal role in driving clinical strategies and advancing life-changing therapies from preclinical stages to clinical success. Your expertise and leadership will be key in shaping the future of oncology treatment while making a tangible impact on patients’ lives.
Key Responsibilities
Strategic Leadership:
- Lead clinical development programs, ensuring alignment with organizational goals and strategic priorities.
- Represent programs at governance meetings, delivering updates on progress and milestones.
- Collaborate with preclinical teams to integrate discovery data into actionable clinical development plans.
Protocol Design and Execution:
- Design and oversee clinical protocols, ensuring compliance with safety and regulatory standards.
- Drive execution of clinical trials, including safety reviews, data analysis, and decision-making for dose escalation and expansion cohorts.
- Prepare and oversee regulatory submissions, including briefing packages and clinical study reports.
External Representation:
- Represent the organization in meetings with partners, investors, and stakeholders.
- Present clinical updates at conferences, advisory boards, and scientific forums.
Requirements and Qualifications
Education:
- MD or MD/PhD with board certification (or equivalent) in oncology or a related field.
Experience:
- Minimum of 5 years in clinical drug development, with a strong focus on oncology.
- Proven track record of leading global clinical trials, particularly early-phase studies.
- Experience with regulatory submission processes (INDs, CTAs, and pivotal filings).