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Associate Director/Director, Clinical Development (PhD or PharmD)

Reference Number: 3904
Location: MD

Our client is a biopharmaceutical company engaged in biologics research and development. They have asked us to assist them in their search for an Associate Director / Director Clinical Development (PhD or PharmD).

Major tasks and responsibilities will include:

  • Contributes to and supports department and clinical initiatives to improve the quality and content of all clinical programs.
  • Develops novel immuno-oncology therapies for cancer patients.
  • Prepares key product documentation.
  • Assists in the creation of the Protocol Concept Sheet (PCS) and the full protocol with support and input from other key team members such as the clinical development physician, Clinical Operations, Biostats, Translational, PK, and Regulatory.
  • Assists in the creation and maintenance of the Clinical Development Plan (CDP) for assigned programs ensuring alignment with the Target Product Profile (TPP).
  • Assists in the development of key documents to support the components of a regulatory submission.
  • Maintains familiarity with the latest thinking regarding mechanism of disease, diagnostic tests, treatment, drug development trends, and regulatory requirements in assigned disease and therapeutic areas.
  • Collaborates with Data Management team to develop the key elements of data review plans for clinical studies and performs medical data review during study execution to ensure integrity of accruing study data.
  • Leads the collection and analysis of Serious Adverse Events under supervision of the Medical Monitor. This includes, but is not limited to, real-time collection and review of SAE information received from clinical sites; interaction with study sites to complete the medical data on the SAE; preparation of SAE narratives for inclusion in Clinical Study Reports and regulatory submissions; ensuring the SAE assessment, including source data, is fully documented in the TMF; facilitation of the reconciliation of clinical and safety databases.
  • Provides Clinical Development input into the tactical execution of clinical protocols by working collaboratively with colleagues in relevant functions.
  • Involved in the selection of clinical research sites and service providers.
  • Interacts with project managers and CRAs from CROs or the company’s Global Monitor Network.
  • Works with third party vendors to ensure protocol end-points are collected appropriately.
  • Participates in Investigator meetings and other scientific committees as required by the protocol.
  • Study risk mitigation and highlighting of potential issues and solutions.
  • Trains personnel and investigational sites to ensure protocol requirements are met.
  • Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems (eCRF), and final reports.
  • Ensures study level activities are conducted to allow implementation of the study protocol in a manner consistent with the current objectives and CDP.
  • Reviews and interprets study results.
  • Assists in preparing publication of study results.
  • Establishes a solid network between company experts in relevant departments, including regulatory, bio-pharmaceutics, discovery, translational medicine, and pharmacology/toxicology sciences, to initiate and expedite clinical studies.
  • Collaborates with translational medicine to optimize the approach to study target neutralization, understand mechanism of action and deploy Personalized Health Care (PHC) strategies.
  • Coordinates with pharmacovigilance personnel in developing the Development Risk Management Plan in conjunction with the company’s Safety Monitoring Committee and other external groups as appropriate.
  • Assists with the management of Scientific Advisory Boards convened to develop CDP strategies as needed.
  • Assists efforts to obtain external scientific and clinical validation of clinical research protocols by establishing links with outside experts to initiate and expedite clinical studies.

We seek candidates with the following qualifications:

  • Advanced degree (PhD, PharmD, MD, or equivalent) in a health science field is required.
  • Requires a minimum of 2 years of experience in clinical research and/or drug development, preferably in oncology or immune-oncology.
  • Must have clinical or research experience related to the design and/or conduct of clinical studies in oncology and/or hematology.
  • Global pharmaceutical experience highly preferred.
  • Requires excellent oral and written skills, strong interpersonal and listening skills; and the demonstrated ability to interact collaboratively in a cross-functional environment.
  • The incumbent must be results driven to achieve creative and sound outcomes.
  • Proven leadership skills required.  
  • Requires the ability to make sound and timely decisions.
  • Must be skillful in negotiating organizational boundaries and hierarchy.
  • Experience managing and developing others highly preferred.

 If interested, please email your resume as a Word attachment to us, reference 3904.  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.