Senior Director, Global Clinical Development – Psychiatry and Neurology

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Develop and manage clinical research programs and protocols for OPDC products in alignment with good clinical practices (GCP).

• Assess and clinically advance CNS and Digital Medicine products at various stages of development for a worldwide healthcare market.

• Collaborate with patients or their representatives, along with clinical, regulatory, and scientific leaders to enhance trial objectives, designs, development plans, and protocols.

• Act as an internal medical/scientific advisor to health economics, medical affairs, marketing, regulatory, statistical, and research project teams, as well as external regulatory bodies.

• Author global development and commercialization strategies, protocols, and study reports.

• Supervise trials that evaluate clinical safety, efficacy, medical utility, and product value.

• Analyze and present Phase I–IV investigation outcomes in preparation for new drug applications.

• Serve as the signatory for NDA submissions and clinical study and safety documentation.

• Contribute to product lifecycle management and identify strategic innovations.

• Provide strategic oversight for vendor and CRO partnerships and clinical insights to governance committees.

• Lead and assist with regulatory filing activities and documentation, offering strategic direction and revisions.

• Collaborate across a matrixed organization to fulfill clinical development and business goals.

⛳️ Requirements

• M.D. or D.O.; ideally a psychiatrist or neurologist.

• Prior management experience, either direct or indirect.

• 6–9 years of experience in the pharmaceutical industry or academic translational clinical research for Senior Director roles, depending on the nature of the experience.

• Comprehensive knowledge of clinical medicine and science management.

• Proficient in effective communication during meetings and through written and oral presentations.

• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

• Proven experience in leading, managing, and motivating internal teams, external investigators, or consultants.

• In-depth understanding of drug development principles and the implementation, management, and reporting of clinical trials.

• Adaptability to work across various therapeutic areas and clinical development phases.

• Familiarity with biostatistics, clinical pharmacology, formulation science, data management, and medical writing.

• Complete knowledge of global regulatory standards.

• Working knowledge of health value creation, including financial assessment, project planning and budgeting, market research, and commercialization strategies.

• Commitment to assigned projects and project objectives within a compliant, regulated, matrixed business environment.

• Willingness to travel 30% of the time, including weekends, and capability to travel internationally.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-sponsored basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-sponsored benefits.

• Incentive opportunities.