Snr Dir, Pipeline Med Aff/Clin Dev Lead (Oncology)

OM36256_1717750778
  • $280000 - $305000 PER ANNUM
  • Connecticut
  • Permanent

Senior Director, Pipeline Medical Affairs, Clinical Development Lead (Oncology)

Location: Hybrid (min 2d/w in office - Connecticut)

ID: OM36256

Company Type: Pharmaceutical (Top 50 global)

Description

The Senior Director, Pipeline Medical Affairs, Clinical Development Lead is critical for steering the company's pipeline assets through the clinical development process towards successful launches. This role synthesizes therapeutic area expertise, insights from external medical authorities, healthcare industry dynamics, regulatory landscape understanding and clinical trial experience. Leveraging this cross-functional knowledge, the Senior Director translates unmet medical needs into an integrated strategic development plan aligning clinical programs with the company's market strategy and informing medical affairs initiatives.

Collaborating across the Clinical Development & Medical Affairs department and interfacing with cross-functional teams including Marketing, Market Access, Analytics, Health Economics, Clinical Operations and legal/compliance, you will execute, measure and iterate the clinical strategy.

This role may oversee and direct a team of Clinical Development Therapeutic Area Leaders. Close partnership with global counterparts ensures strategic alignment worldwide.

Duties & Responsibilities

  • Co-creates global clinical development plans to meet US market needs (trial design, comparators, biomarkers) from early phase to approval.
  • Ensures US voice is represented through external expert input.
  • Oversees product development for therapeutic area lifecycle.
  • Leads excellence in clinical development and integrated evidence planning with US/global teams.
  • Promotes synergies across product lifecycle, provides input on clinical development, commercial strategies.
  • Represents CDMA on governance bodies (CEC, Evidence Teams, HPSC).
  • Provides medical input (Target Product Profiles, Development Plans, Protocols, Regulatory).
  • Guides clinical trial program, continuous benefit-risk assessment.
  • Leads regulatory meetings, contributes to submissions/safety for US.
  • Supports external expert engagement (boards, committees).
  • Identifies/prioritizes evidence generation programs, inputs on medical affairs strategies.
  • Collaborates with strategy teams to integrate insights into clinical development processes.

Requirements

  • Doctoral degree (e.g., PhD, DO, PharmD, DNP, MD) required.
  • Strong experience (8+ yrs) in the pharmaceutical/biotechnology industry preferably in Pipeline Medical Affairs or Clinical Development roles.
  • Proven clinical/academic experience in Oncology, preferably Lung Cancer or GI cancers.
  • Demonstrated experience in executing medical affairs tactics, process improvement, product launches, and integrated evidence generation.
  • Strong record in developing and implementing clinical research/medical strategies, including evaluating value-oriented research and communication approaches.
  • Deep understanding of the US healthcare system, regulatory landscape, and needs of providers, patients, payers, and caregivers in Oncology.
  • Ability to lead collaboratively with executive presence, drive performance excellence, and foster innovation across therapeutic areas and levels.
  • Skilled at translating science into clinical patient value while adhering to US/global SOPs and instructions.
  • Excellent written and oral communication skills for presenting complex information to scientific/academic audiences and media.
  • Strong grasp of the fast-evolving US healthcare landscape for Oncology, medical/pharma/payer dynamics, portfolio growth.
  • Ability to manage multiple simultaneous projects, identify risks and meet medical market needs with urgency.
  • Willingness to travel with overnight stays as required by the role.
Oliver Morkel Associate Director / AVP

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