Associate Director, Clinical Development, Oncology

East Coast / United States
4468
Our client is a global biopharmaceutical company. They have asked us to assist them in their search for an Associate Director, Clinical Development, Oncology.  

Major tasks and responsibilities will include:
  • Oversees typically a single non-pivotal trial.
  • Prepares clinical section of regulatory document.
  • Collaborates as team member with AROs/CROs.
  • Outlines development plans, protocol profiles, and divisions of submission documents under higher level guidance.
  • Reviews and oversees completion of clinical trial protocols.
  • Provides medical and/or scientific guidance to Clinical Operations.
  • Represents Clinical Development on cross-functional teams.
  • Provides strategic direction to Biostats Data Management & Data Operations.
  • Evaluates patient population and protocol compliance for consistency with study strategy.
  • Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm.
  • Potentially acts as Clinical study leader (CSL).
  • Contributes to major milestones of trial and planning.
  • Analyzes and updates management on potential risks to study deliverables.
  • Oversees recruitment and retention.
  • Establishes and implements contingency plans for shortfalls.
  • Recruits members for adjudication committee.
  • Drafts responses to IRBs and Health Authorities.
  • Works with Translational Medicine and Clinical Pharmacology to ensure proper biomarker, PK/PD measurements.
  • Reviews developing clinical data on a regular basis.
  • Leads dose-escalation meetings.
  • Performs quality assessment with Delivery Lead.
  • Consults with experts for protocol development.
  • Creates valuable communication among CRO/vendors/ARO.
  • Interacts occasionally with senior management.
  • Instigates contact w/KOL and arranges material for KOL communications on a program based need.
  • Connects with in-licensing and acquisitions on individual due diligence activities.

We seek candidates with the following qualifications:
  • MSc or MPH is required.
  • PharmD, PhD, or equivalent are desirable.
  • Postgraduate training in Therapeutic Area is desirable.
 
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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