Director, Global Clinical Development

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

📋 Description

• Design and manage clinical research programs and protocols for OPDC products in accordance with good clinical practices.

• Assess and clinically advance CNS and Digital Medicine products at various stages for the global healthcare market.

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

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

• Draft strategies for global development and commercialization plans.

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

• Analyze and convey results from Phase I–IV investigations in preparation for new drug applications.

• Serve as a signatory on NDA submissions and clinical study and safety documents.

• Assist in product lifecycle management and identify strategic innovations.

• Provide strategic oversight of vendor and CRO relationships, along with clinical input to governance committees.

• Lead and facilitate regulatory filing activities and documentation, offering strategic direction and editing.

• Create concise, clear, and persuasive written and verbal communications.

⛳️ Requirements

• M.D. or D.O.; preferably with a specialization in nephrology or immunology.

• Previous management experience, whether direct or indirect.

• Background in the pharmaceutical industry or academic translational clinical research; generally 3–6 years for Director level, contingent on experience type.

• Extensive knowledge of clinical medicine and science management.

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

• Familiarity with Microsoft Word, Excel, PowerPoint, and Outlook.

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

• Advanced understanding of drug development principles and the implementation, management, and reporting of clinical trials.

• Flexibility across various therapeutic areas and stages of clinical development.

• Working knowledge of biostatistics, clinical pharmacology, formulation science, data management, and medical writing.

• Comprehensive understanding of global regulatory requirements.

• Familiarity with health value creation, financial evaluation, project planning and budgeting, market research, and commercialization strategies.

• Commitment to projects and objectives in a compliant, regulated, matrixed business environment.

• Willingness to travel 30% of the time, including weekends, with the 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-provided benefits.

• Incentive opportunities.