Senior Director, Clinical Development (MD)

Location
San Francisco, CA
Posted
Oct 11, 2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Description

Portola Pharmaceuticals, Inc. seeks an oncologist and/or hematologist to provide medical and scientific direction in the clinical evaluation of its cerdulatanib program, a potential breakthrough oncology therapy. The Senior Director, Clinical Development will report to the Senior Vice President, Chief Medical Officer and should be fluent in program and study design, conduct and analysis.

  Responsibilities:

  • Provide hands-on participation in the clinical program and trial development process ; conceive and execute clinical strategy and contribute clinical expertise for the research and development project
  • Serve as the Medical Monitor for clinical trials (Phase 2 and Phase 3)
  • Assist in preparation of clinical sections of all relevant documents and regulatory filings (Investigator brochure, IND, and study reports)
  • Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan
  • Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources
  • Interact in collaborations with strategic partners
  • Responsible for clinical development plan in highly competitive therapeutic areas
  • Provide input/review study start up documentation, e.g. CRF design, source data verification plans based on protocol specifications
  • Attend and provide scientific support for investigator and consultant meetings and other study implementation workshops
  • Manage studies and provide expertise on clinical and medical issues to other colleagues and study site staff
  • Review study data
  • Evaluate Serious Adverse Events (SAEs) and provide input on safety reports
  • Author clinical sections for final study reports
  • Participate in preparation for submission activities as appropriate
  • Assist in the development of publications, abstracts, and presentations

 Qualifications:

  • MD with experience in the pharma/biotech industry conducting and interpreting human clinical studies with 5 or more years of experience
  • Board eligibility/certification in hematology and/or oncology preferred
  • Knowledge of or experience in hematologic malignancies strongly preferred
  • Experience in small molecule clinical development preferred
  • Ability to direct strategic interactions and partnerships with outside collaborators, such as academic research groups, corporate partners, CROs and other vendors
  • Reputation as a leader in the field with sustained performance and accomplishments as evidenced by quantity and quality of publications, patents, regulatory filings and/or other technical documents
  • Proven abilities in the review and interpretation of complex scientific data in order to form appropriate clinical opinions
  • Strong interpersonal, team and collaborative skills, ability to function and influence effectively in a broad multidisciplinary group; consistently looking for win-win solutions to problems
  • Passion for continued learning and mentoring
  • Results-oriented, self-driven and motivated individual who enjoys the immediacy of personal effort and impact