Medical Director, Oncology Clinical Scientist

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Medical Director, Oncology Clinical Scientist to join our Oncology Clinical Development program to work collaboratively with the members of the clinical development team to establish the clinical development plan(s) for one from lead development in discovery to Phase I-II clinical trials, and for designing/executing and reporting protocols for studies included in the development plan, as well as to provide assessment of competitive landscape for strategic direction for clinical trial and non-clinical trial options and participate in strategic decisions related to clinical evidence to clinical development.
  • Collaborates with various internal and external experts or agencies to assist in clinical/non-clinical strategy, the development of study designs, and scientific publications.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Contributes to or may independently design protocols, amendments and conduct data review, analysis and interpretation.
  • May participate in regular review of individual subject safety data and performs review of cumulative safety data with the Medical Monitor/Medical Director
  • In conjunction with members of the development team may prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
  • Interface with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators.
  • May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues.
  • May participate in due diligence activities such as due diligence reviews and reports

Requirements

  • Excellent oral and written communication skills
  • Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
  • Degree in life sciences; Advanced scientific preferred (PhD, PharmD, MA); demonstrated experience in oncology drug development, early development preferred; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences); demonstrated scientific writing skills and good communication skills
  • 7+ years in clinical development

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded.