Medical Director / Senior Medical Director

Responsibilities

• Provides clinical development and medical leadership/oversight of clinical programs to ensure timely delivery of clinical deliverables.
• Safeguards clinical programs to support patient safety and oversees patient safety in clinical studies.
• Acts as the primary medical expert for assigned study(ies), serving as the initial point of contact internally and externally for questions regarding the study (e.g., eligibility, enrollment; safety and patient management).
• Maintains oversight of study progress to ensure proper study conduct and adherence to the protocol, leads data review, evaluation, and analyses with support from the cross-functional team.
• Takes a key role in the authoring of critical study documents (e.g., CSR, IB, protocol synopsis).
• Contributes to the analysis and interpretation of data generated internally or externally and presents study updates, interim results, and final headline data to senior management as required.
• Provides medical input and contributes to the clinical development sections of regulatory documents such as IND, CIOMS, DSUR, Dossiers, and responds to regulatory agencies regarding complex clinical development issues (e.g., safety or efficacy).
• Collaborates with teams on the development of translational and precision phenotyping strategies and contributes to the design of scientifically rigorous clinical development studies and programs utilizing a data biopsy signature/precision phenotype approach.
• Identifies and engages with external Key Opinion Leaders to address scientific and medical questions relevant to the program.
• Helps identify global study sites and fosters relationships with study investigators.
• Ensures that Serious Adverse Events are properly reported.
• Implements clinical R&D policies, SOPs, and related directives.
• Supports any needed due diligence of potential in-licensing drug candidates and presents recommendations to leadership.

Qualifications

• MD required; Ph.D. and/or board certification in psychiatry preferred.
• Active medical license desirable.
• 3+ years of relevant experience as a Medical Director in the biotech or pharmaceutical industry or equivalent.
• Psychiatry drug development experience required, Psychogeriatric or Neurodegeneration development experience a plus.
• Experience in leading medical and scientific aspects of clinical studies on cross-functional teams.
• Able to critically review, analyze and interpret key aspects of clinical study conduct, including research design, methods, and outcome measures.
• Able to work in a remote environment and with distributed teams; startup experience preferred.
• Effective communication skills to enable engaging and influencing diverse stake holders from a variety of professional backgrounds.
• Able to navigate complexity and make risk-based decisions.
• Self-starter who can independently lead assigned projects.
• Demonstrated ability to engage and influence diverse stakeholders from a variety of professional backgrounds.