Executive Director/Vice President, Clinical Development

Primary Responsibilities

• Establish and drive the clinical development strategy and hands-on tactical execution plans on programs against the current and future development portfolio.
• Manage effective internal and external relationships, internally with members of the executive leadership team, regulatory affairs, clinical operations and medical affairs, and externally including regulatory agencies, partners, KOLs, and investigators.
• Medical oversight of ongoing clinical trials in the neuropsychiatric therapeutic area.
• Lead clinical sections of regulatory documents (IND, BLA/NDA).
• Work with Regulatory Affairs to prepare for meetings with FDA and healthcare authorities.
• Work with Scientific Communications/ Medical Affairs team members to organize and prepare for advisory board meetings.
• Work with other members of the Program team through all phases of development through commercialization.
• Prioritize and develop the company’s current drug candidates as well as future pipeline compounds and contribute to go / no-go decisions.
• Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process.
• Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards.
• Actively participate in strategic planning for the clinical development organization and provide support to business development / licensing activities.
• Maintain an understanding of competitors and clinical developments in relevant therapeutic areas.
• Build and maintain medical advisory boards based on solid working relationships with KOLs and lead clinical investigators.

Requirements

• MD training in psychiatry and/or neuroscience required.
• 8+ (ED) 10+(VP) years of clinical development experience within a biotech/pharmaceutical setting with a strong track record of successful clinical program execution in the field of neuropsychiatric drug development. Prior clinical/academic experience required as well.
• Experience with mood/anxiety disorders preferred.
• Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, interpretation of clinical data and generation of supporting regulatory submissions of clinical study documents.
• Demonstrated track record and experience working cross-functionally in a collaborative and productive manner across R&D functions and beyond.
• Exceptional interpersonal, influencing, presentation, and written and verbal communication skills.
• Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
• Experience with Phases I-III clinical development required.
• Understanding of the general healthcare environment in the US and elsewhere-including laws, regulations, and evolving market access trends and issues.
• Knowledge and experience of building clinical development infrastructure aligned with the needs of a growing organization.
• Occasional work travel as required.