Medical Director
Stealth Mode Biotech in Boston, CNS-focused
Reports To: Chief Medical Officer (CMO)
Company
The company is a new clinical stage biotechnology company based in Boston currently in stealth mode. They are focused on developing new therapies for major indications in neuropsychiatry, including anxiety and substance use disorder. The company has four clinical stage molecules in development, all with comprehensive pre-clinical pharmacology, toxicology and human phase 1 data. The company is backed by several large international VCs and plans to come out of stealth mode in early 2025.
Position Overview:
The Medical Director will be a key member of the Clinical Development team, responsible for the strategic planning, execution, and oversight of clinical trials across the company's CNS-focused portfolio. The ideal candidate will possess extensive experience in clinical development and CNS therapeutics, as well as a deep understanding of regulatory guidelines and safety management.
Key Responsibilities:
- Lead the clinical and scientific aspects of multiple programs.
- Oversee the medical and scientific aspects of clinical trials, ensuring adherence to protocol, regulatory requirements, and company objectives.
- Collaborate with cross-functional teams to drive the clinical development strategy and ensure alignment with corporate goals.
- Manage interactions with key opinion leaders (KOLs), regulatory agencies, and external clinical sites, fostering relationships that contribute to the success of the programs.
- Organize and lead Clinical Advisory Boards for the assigned programs
- Review and interpret clinical data, provide insights for data-driven decision-making, and assist in preparing publications, regulatory submissions, and presentations.
- Provide clinical expertise to the wider team to support the continued growth and development of the pipeline.
- Develop and review clinical development documents, including study protocols, investigator brochures, and clinical study reports (CSRs).
- Mentor and guide junior clinical staff, providing leadership and training to ensure high standards of clinical trial execution.
Qualifications:
- M.D., D.O., or equivalent medical degree required. MD/PhD degree is a plus.
- Strong background in clinical research and scientific analysis, with the ability to interpret complex data and drive clinical decisions.At least 5 years of experience in clinical development within the biotech or pharmaceutical industry, with a strong focus on CNS disorders.
- In-depth knowledge of clinical research, including clinical trial design, regulatory requirements (FDA, EMA, etc.), and GxP guidelines.
- Experience in managing clinical trials for anxiety, pain, and/or drug abuse is highly preferred.
- Experience in pharmacovigilance and safety management is a plus.
- Strong interpersonal and communication skills, with the ability to work effectively with internal and external stakeholders.
- Ability to thrive in a fast-paced, dynamic, and collaborative environment.
- Experience with IND submissions, and other regulatory interactions is highly desirable.
- Previous leadership experience in clinical development teams and mentoring of clinical staff is preferred.
