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Medical Director, Hematology

Reference Number: 4089
Location: USA

Our client is a global biopharmaceutical company. They have asked us to assist them in their search for a Medical Director, Hematology.

Major tasks and responsibilities will include:

  • Responsible for concept development and design of clinical trials.
  • Participates in or leads a matrixed clinical development team.
  • Oversees the creation and maintenance of a scientifically sound clinical development plan aligned with regulatory and commercial strategies.
  • Serves as the primary clinical strategy representative on the cross-functional teams.
  • Responsible for clinical development sections of project planning, generation of study synopses, and analysis of clinical study results.
  • Provides medical review for study relevant documents such as protocols, clinical study reports, and Investigator Brochures.
  • Reviews study specific plans covering data coding conventions, data reconciliation procedures, statistical analysis plans, informed consent documents, etc.
  • Provides review of final study reports.
  • Responsible for study specific medical responsibility plans to document medical monitoring activities required for a specific study.
  • Participates in the writing of clinical efficacy components of regulatory dossiers and oversees other contributions as relevant.
  • Provides guidance on the clinical aspects of regulatory strategy in support of the filing of INDs/CTAs and license applications throughout the development lifecycle.
  • Leads, or contributes to, the preparation of clinical sections for regulatory meetings and attends/presents at such meetings (e.g. pre-IND or end Phase II meetings/ Scientific Advice/ Advisory Boards) where required.
  • Collaborates with Commercial (Development/Operations) and Clinical Operations to identify key investigators.
  • Develops strong relationships with lead investigators within assigned therapeutic area, and actively participates in investigator meetings.
  • Acts as Medical Monitor, serving as the physician point of contact for an Investigator site.
  • Provides medical expertise for responding to specific inclusion/exclusion criteria questions and resolving study related issues.
  • Accountable for overall medical and safety decision making at the study level.
  • Spearheads the medical review for data monitoring committees and endpoint adjudication boards as needed.
  • Contributes to the identification of clinical consultants and aids in providing them with direction.
  • Remains current on industry trends, with solid understanding of key disease states, treatments, competitive agents and development projects within the assigned therapeutic area.
  • Oversees Clinical Scientists and contributes to their development through active participation in training and mentoring activities.
  • Participates in due diligence on external business development opportunities.

We seek candidates with the following qualifications:

  • Medical degree with Board Certification in Hematology or relevant sub-specialty required, MD/PhD highly preferred.
  • Must have a minimum of 3+ years of clinical development experience in either a pharmaceutical or academic setting.
  • Requires working knowledge and solid understanding of pharmaceutical and regulatory development processes.

If interested, please email your resume as a Word attachment to us, reference 4089.  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