Medical Director, Clinical Development, Psychiatry

This is a fully remote position, open to applicants in California.

📋 Description

• Accountable for creating clinical research strategies and autonomously directing Phase 1-3 clinical studies while collaborating with cross-functional project teams, including clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory affairs, and drug safety.

• May collaborate closely with Research and Preclinical Development to establish biomarkers essential for the optimal evaluation of novel molecules during early clinical development.

• Responsible for overseeing Drug Safety activities in conjunction with the operational responsibilities of the Drug Safety Director.

• Partners with Business Development to evaluate external innovations.

• Develops and implements study protocols in collaboration with a multidisciplinary Development Team.

• Aids in identifying and selecting clinical investigators for trials, ensuring effective communication and professional relationships as the Sponsor medical monitor/representative.

• Conducts medical assessments and determines the disposition of adverse events (in coordination with the Drug Safety physician) and assesses the safety of clinical compounds prior to and throughout ongoing clinical studies.

• Supervises the clinical trials program alongside Clinical Operations, adhering to NBI SOPs, Good Clinical Practice, and applicable regulations.

• Analyzes, interprets, and presents clinical study results to both internal and external audiences as directed by Senior Management.

• Identifies resource needs, assists in budget planning, and forecasts personnel for clinical research programs.

• Aids in the recruitment, training, and development of clinical teams.

• Identifies and selects clinical consultants.

• Provides or assists in the scientific writing and review of clinical study reports and related regulatory documents.

• Delivers periodic status updates and effectively communicates with the Senior Management Team.

• Leads the establishment of clinical biomarker strategies for early clinical development.

• Collaborates with Medical Affairs and external opinion leaders to secure new partnerships and present trial findings.

• Interfaces with Research, Product Development, and Business Development to evaluate new product opportunities and develop clinical research strategies and product development plans.

⛳️ Requirements

• MD or DO degree with accredited residency training and board certification in the relevant clinical specialty for the therapeutic area is required.

• A minimum of 2 years of experience in clinical research and development (Phase 1-4) within either a pharmaceutical/biotechnology company or a clinical research/academic environment, or equivalent experience, is required.

• Recognized as an internal thought leader with comprehensive technical and business expertise within a strategic organization.

• Utilizes in-depth knowledge of their function, as well as business, commercial, and scientific expertise, to effectively address critical issues in an innovative manner.

• Assesses key business and scientific challenges and successfully completes complex, ambiguous initiatives that have cross-functional impacts.

• Strong interpersonal, communication, organizational, and team leadership skills are essential.

• Capable of working independently and prioritizing multiple tasks and objectives to ensure timely, on-target, and budget-compliant outcomes.

• Knowledgeable in Good Clinical Practice and regulatory procedures relevant to investigational drug development.

• Strong understanding of translational medicine, biomarker evaluation, clinical study execution, regulatory requirements, study design, biostatistics, data analysis, report writing, and scientific data presentation.

• Able to effectively function in a complex multi-level matrix corporate environment, necessitating interaction with and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative personnel, regulatory staff, and consultants.

• Demonstrated success in managing interactions with external CROs, consultants, and other contract organizations, particularly in the context of a small group.

• Proven track record of success across all phases of drug development, including a successful history in clinical trial design.

🏝️ Benefits

• Health benefits including medical, prescription drug, dental, and vision coverage as per the terms and conditions of the applicable plans.

• Retirement savings plan with company matching.

• Paid vacation.

• Holiday and personal days.

• Paid caregiver/parental and medical leave.

• Annual bonus with a target of 35% of the earned base salary.

• Eligibility to participate in our equity-based long-term incentive program.