Executive Medical Director, Clinical Development CV/Renal/Metabolism

Regeneron Pharmaceuticals • Tarrytown, GA

16d • Onsite

About The Position

The Executive Medical Director, Clinical Sciences, Obesity is responsible for effectively managing obesity opportunities in an end-to-end framework (clinic entry through lifecycle management). This will require engagement with both Discovery and Medical Affairs as key stakeholders, in addition to other functional stakeholders (e.g., Clinical Pharmacology, Biostatistics, Precision Medicine, Imaging, Genetics Center, Preclinical Safety, Regulatory, Commercial, etc). It requires a rich scientific focus with contribution to obesity strategy: target selection, clinical planning, target engagement, dose selection, proof-of-concept, and pivotal study design and conduct, label negotiation, and lifecycle management. For designated programs, the Clinical Program Lead (CPL) will be responsible for multiple indications driving broader cross functional perspective in the creation of clinical program development strategies. This role reports into the Internal Medicine CVRM VP Therapeutic Area Lead and is also leader of select Global Clinical Sub-Teams for the design, implementation, execution and submission/approval of clinical development programs to support decision milestones and regulatory requirements. A typical day in the life of an Executive Medical Director may include the following: Leads the Global Clinical Subteam (GCST) and clinical development representative at the Strategic Program Team (SPT) for assigned assets, managing all clinical aspects and driving execution of assigned clinical program(s) Leads the development and execution of the Clinical Development Plan (CDP) including Phase 1 – 3 trials designed for successful global registration of the compound. Leads creation of clinical components of key documents (regulatory documents, registration dossiers, etc.) supporting registration, market access, and commercialization of the compound(s). Acts as medical expert and leader in interactions with external and internal stakeholders Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety. Ensures quality of all clinical documents (e.g., Investigators’ Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents) produced by GCST Builds and leads effective teams. Manages and oversees activities of teams up to Senior Medical Director level; Establishes operational objectives and work plans, delegating assignments to subordinate staff. Partner with operations team to ensure high quality execution of the clinical development portfolio Partners and helps lead BD processes.

Requirements

• MD or MD/PhD required with specialized residency and fellowship training
• >8 years of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4.
• ≥6 years people management experience desirable, this may include management in a matrix environment.
• Strong management, interpersonal, communication, negotiation and problem-solving skills.
• Considerable organization awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally.
• Understanding of global regulatory environment including key regulatory agencies and approval processes
• Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)
• This role requires 4 days per week on-site in Tarrytown, NY

Nice To Haves

• Medical/scientific expertise in Endocrinology, CV/Metabolism, and/or Obesity is strongly preferred

Responsibilities

• Leads the Global Clinical Subteam (GCST) and clinical development representative at the Strategic Program Team (SPT) for assigned assets, managing all clinical aspects and driving execution of assigned clinical program(s)
• Leads the development and execution of the Clinical Development Plan (CDP) including Phase 1 – 3 trials designed for successful global registration of the compound.
• Leads creation of clinical components of key documents (regulatory documents, registration dossiers, etc.) supporting registration, market access, and commercialization of the compound(s).
• Acts as medical expert and leader in interactions with external and internal stakeholders
• Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.
• Ensures quality of all clinical documents (e.g., Investigators’ Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents) produced by GCST
• Builds and leads effective teams.
• Manages and oversees activities of teams up to Senior Medical Director level
• Establishes operational objectives and work plans, delegating assignments to subordinate staff.
• Partner with operations team to ensure high quality execution of the clinical development portfolio
• Partners and helps lead BD processes.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree