Sr. Director, Clinical Development

Boston, MA

Description:

The Senior Director, Clinical Development will lead the design and execution of clinical development programs. He/She will provide clinical guidance to oncology projects and present clinical data and strategic plans both internally and externally.

Essential Function & Duties:

  • Lead the design and execution of clinical studies focused on selected pipeline products in development.
  • Lead the overall conduct of research programs including medical monitoring, evaluation and management of safety issues, analysis and interpretation of data and interactions with investigators and key opinion leaders.
  • Provide clinical guidance to oncology projects in preclinical development to insure that those projects appropriately address unmet medical needs and are clinically relevant.
  • Present clinical data and strategic plans at cross-functional meetings with both internal and external partners, as well as at external meetings such as academic symposia and meetings with regulatory authorities.
  • Integrate pharmacokinetics, biomarkers, pharmacogenetics and pharmacogenomics, biostatistics, drug safety and regulatory strategy into the creation of practical clinical development plans.
  • Assist in the identification of clinical investigators and coordinating their activities in the conduct of clinical trials and advisory board meetings.
  • Assist in the development of case report forms used to capture data from clinical protocols
  • Provide guidance for clinical data organization and interpretation.
  • Monitor/analyze clinical trials for safety and, when appropriate, efficacy. Work in conjunction with Drug Safety & Pharmacovigilance to insure timely reporting of safety signals to regulatory authorities.
  • Supervise and accountable for the generation of clinical study reports. Provide drug safety data/interpretation for the generation of clinical study reports.
  • Work closely with other functional groups to facilitate the execution of clinical trials.
  • Provide clinical and drug safety sections for INDs, Annual Reports, and NDA/BLAs.
  • Develop and retain external relationships, e.g., with CROs, other pharmaceutical sponsors, clinical investigators and key opinion leaders.
  • Provide guidance for the interpretation of drug safety data.
  • Contribute clinical knowledge, insight and skill to project teams and to various clinical sub-teams.

Skills:

  • A broad-based knowledge of clinical disease processes and their management, a command of current standards and evolving trends in medical practice, and the ability to be conversant with the basic sciences (physiology, pathology, pathophysiology, pharmacology, biochemistry, molecular biology, and biostatistics) is required as well as the ability to translate preclinical information into potential clinical application.
  • The ability to communicate clearly with both peers and individuals with less training or with expertise in other functional areas as well as facility with both public speaking and written communication are required.
  • Fluency in both the spoken and written English language is required.
  • The Senior Director must be flexible at a behavioral level, capable of exerting sound business judgment and adhere to the highest ethical standards at all times.
  • He/she must not only be highly competent technically and motivated as an individual, but must also be capable of inspiring other accomplished professionals to achieve excellent performance.
  • The company has a highly collaborative and results-driven culture, the Senior Director must exhibit a strong orientation toward team work and collaboration.

Education & Experience:

  • MD degree with advanced scientific training/experience in Medical Oncology.
  • Board certification (or a foreign equivalent) is highly desirable.
  • Three (3) years or more of prior direct patient care experience as well as some clinical and/or bench research experience.
  • Two (2) or more years of small molecule and/or biologic drug development experience in oncology and/or immune modulation is needed.
  • First-hand experience in immunotherapy of cancer, preferred.
  • Gene therapy experience is a plus.
  • Prior experience working in a fast-paced, small company environment is critical.

Apply Now