Primary Responsibilities

• Establish the clinical development strategy and hands-on tactical execution plans against the current and future development portfolio.
• Manage effective internal and external relationships, such 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.
• Lead clinical sections of regulatory documents (IND, BLA/NDA).
• Work with Regulatory Affairs to prepare for meetings with FDA and healthcare authorities.
• Work with Medical Affairs to organize and prepare for advisory board meetings.
• 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.
• Build and lead a team, creating an environment where team members thrive and deliver outstanding results.

Requirements

• PhD or MD required, training in neuroscience or neurology preferable
• 15 years of global clinical development experience leading the clinical development strategy in a biotech or pharmaceutical company
  • VP or SVP title commensurate with relevant experience
• 5-10 years experience managing teams preferred
• Demonstrated ability to attract talent, lead, inspire, and grow and develop teams
• Track record of innovative, strategic leadership, and flawless execution in the field of neurological and/or neuropsychiatry drug development.
• 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.
• Success leading the design and execution of effective clinical development strategy.
• 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.
• Understanding of the general healthcare environment laws, regulations, and evolving market access trends and issues.
• Knowledge and experience of building clinical development infrastructure as organizations grow.