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Senior Director Clinical Science

Reference Number: 3664
Location: MA

Our client is a biopharmaceutical company.  They have asked us to assist them in their search for a Senior Director Clinical Science.  

Major tasks and responsibilities will include:

  • Leads a team of clinical scientists and is responsible for talent management of the Clinical Science department.
  • Builds core competencies and establishes standards relating to key clinical scientist deliverables including but not limited to clinical data review, protocol development, study execution.
  • Develops a talent strategy for the department, and works with HR to identify, hire, and on-board associates.
  • Conducts the performance management and compensation planning process for the team.
  • Coaches, manages and provides individual developmental opportunities to Clinical Science team members.
  • Oversees clinical scientist associates, provides senior support and guidance for priority clinical research deliverables.
  • Integrates strategies, tactics and programs to accomplish clinical science objectives.
  • Contributes to and reviews synopses, protocols, amendments.
  • Provides medical review and interpretation of data, reviews draft reports and publications, searches and analyzes medical/scientific information.
  • Works closely with the Medical Director on the data monitoring, signal detection and required follow up.
  • Assists in or designs, authors and/or reviews clinical study synopses, protocols, amendments, study reports and other study-related documents.
  • Collaborates with all preclinical and clinical resources (internal and external) including CROs, IRBs, data handling, logistics, bioassay, data management, biostatistics and medical writers as needed.
  • Prepares clinical sections of registration documents; provides input on preparation of other key clinical documents.
  • Assists in database finalization, reviews and interprets study results.
  • Assists in identifying/evaluating vendors.
  • Assists with field site questions during conduct of trials.
  • Represents Clinical Science department to key stakeholders and committees.
  • Provides reporting to SVP Clinical Research to track progress of Clinical Science department.

We seek candidates with the following qualifications:

  • Must have an advanced degree; MD, PhD, MSc/MPH, PharmD is preferred.
  • Must have 15 years of experience within a pharmaceutical company environment.
  • Must have knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area.
  • Requires experience with clinical scientist activities for all stages of clinical development, preferably including initiation and closure of registrational studies that have been included in market authorization applications.
  • Managerial and training experience is required, preferably within a group of clinical scientists.
  • Requires a thorough understanding of clinical research methodology including study design, protocol writing; CRF preparation and knowledge of GCP and local regulatory requirements are required.
  • Requires the ability to handle and prioritize multiple studies and work in a fast-paced, autonomous environment.

 

If interested, please email your resume as a Word attachment to us, reference 3664.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.