Medical Director, Bipolar Disorder Program

Medical Director, Bipolar Disorder Program

Clora’s client is a clinical‑stage biopharmaceutical company focused on small molecules for central nervous system (CNS) disorders. This 1099 Consultant Opportunity is aimed at an interim Medical Director who will provide clinical leadership and strategic medical input for all clinical deliverables in the Bipolar Disorder program.

Base pay range: $210.00/hr – $350.00/hr

Duration: Estimated 30 hours per week for 6 months

Location: Remote – USA

Responsibilities

• Provide clinical leadership and strategic medical input for all clinical deliverables in the Bipolar Disorder program.
• Drive execution of the assigned clinical program and/or clinical trial in partnership with clinical operations.
• Contribute to the development of regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports, responses to regulatory authorities, Ethics Committees/IRBs, and other documents as appropriate.
• Ensure scientific rigor and innovation are at the forefront of the client’s clinical development strategy.
• Manage engagements with external organizations, key opinion leaders, and advisors.
• Support the Head of Clinical Development by providing medical input into clinical development strategy and protocol reviews.
• Work closely with functional partners (Clinical Operations, Data Management, Biostatistics, Regulatory, Medical Affairs) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocols.
• Establish strong collaborations with study investigators and outside medical experts and represent the client during investigator meetings and advisory boards.
• Serve as the medical monitor for assigned studies, including design, execution, and interpretation of study data.

Ideal Candidate

• MD or equivalent medical degree (required).
• Minimum five years of experience in the biotech/pharmaceutical industry in clinical research, drug development, or as a study investigator.
• Advanced knowledge and clinical training, and/or drug development experience in neuropsychiatry (preferred).
• Proven clinical development strategist with hands‑on experience designing, implementing, and conducting clinical trials in psychiatry (Phase 2a and Phase 3).
• Working knowledge of Bipolar Disorder and proven ability to interpret, discuss, and present efficacy and safety data from clinical trials.
• Demonstrated ability to establish effective scientific partnerships with key stakeholders.
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
• Experience authoring regulatory documents, especially the IND/NDA/BLA approval process.
• Ability to communicate and work independently and collaboratively across disciplines.
• Critical thinking and strong troubleshooting/problem‑solving skills.
• Comfortable in a fast‑paced small startup environment with minimal direction and able to adjust workload based on changing priorities.

Direct message the job poster from Clora for more information.