Medical Director- Head of Clinical development

This is a contract to hire role.

Hybrid role
-Purchase, NY

Expereince in working with FDA on various approvals- huge plus

POSITION SUMMARY

The Head of Clinical Development serves as the medical lead for a CNS programs. Working with the Chief Medical Officer, the internal team, consultants, and potential clinical trial partners, the Head of Clinical Development has ultimate responsibility for optimizing clinical trial design from proof-of-concept through registration-enabling clinical studies and leading Company’s drug safety program.

The position requires expertise in clinical development, with a strong understanding of the particular challenges of neurodegenerative disorders, as well as outstanding clinical and scientific knowledge applicable to clinical research. The role includes significant external interaction, building relationships with study sites, development partners, and the medical/scientific community.

KEY RESPONSIBILITIES

• Clinical Trial Design and Execution
• Lead, design, and coordinate activities to support Phase II/III clinical programs in Alzheimer’s disease and dementia with Lewy Bodies.
• Design and direct execution of clinical development research studies to evaluate therapies for efficacy, safety, clinical pharmacology, and pharmacokinetics.
• Direct all aspects of clinical trials including study concept, protocol and timeline development, site identification, investigator meetings, medical monitoring, safety, data review and interpretation.
• Develop unique and innovative clinical strategies to improve clinical development through faster studies and/or novel outcome measures.
• Serve as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, KOLs, advisory boards), internal stakeholders (e.g., R&D, Clinical Operations, Development Operations), and internal decision boards (senior management and Board of Directors).
• Lead the drug safety program including cross study, study specific surveillance, and reporting to regulatory agencies, focusing on events, reporting and surveillance of patients in clinical studies and provide regular updates to DSMBs.
• Financial Management
• • Develop clinical trial budgets

Regulatory

• • Ensure the quality of all clinical documents (e.g., investigators’ brochure, protocol, study report,
• clinical components of regulatory submissions, safety related documents), with support from
• Quality and Regulatory functions
• • Lend clinical expertise to responses to regulatory agency questions and regulatory
• submission documents
• Communications and Publications
• • Plan and execute publication and clinical communication strategy in coordination with
• Company’s Communications and IR/PR teams.
• • Provide input to key external medical/scientific meeting presentations; as appropriate,
• author scientific papers for journal publication.

QUALIFICATIONS

Education & Experience

• • MD or DO (or equivalent) with direct experience with CNS-related disorders, specifically dementias
• • 10+ years of industry drug development experience to include all stages with Phase II and III clinical
• trial design essential; NDA experience is a plus
• • Industry experience to include responsibility as a Senior Director or Medical Director for designing,
• leading, and managing clinical studies
• • Familiarity with the requirements of a drug safety program (extensive pharmacovigilance experience is not required)

Skills & Knowledge

• • Strong understanding of the drug development process evidenced by the ability to execute
• and deploy drug development strategic plans, develop contingency plans, provide technical
• and strategic advice, and develop/meet milestones and budgets.
• • Strong knowledge of Good Clinical Practices, FDA regulations and guidelines, and related
• regulatory requirements.
• •…