Medical Science Director, Medical Evidence

Location
San Francisco, CA, United States
Posted
Nov 17, 2020
Ref
832
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
MEDICAL DIRECTOR/MEDICAL SCIENCE DIRECTOR, MEDICAL EVIDENCE

Position Summary:

The MD/MSD will support development and implementation of research strategies to provide supplementary evidence and long-term follow-up for GBT products and therapeutic areas of interest. He/she will help the Executive Director, Medical Evidence assess evidence gaps and develop a roadmap to support the Medical Affairs and Value Evidence strategy, with a focus on the design and execution of Phase 3b/4 studies, Externally Sponsored Research Collaborations, Expanded Access Programs, and Product Registries. The MD/MSD, Medical Evidence will report directly to the ED, Medical Evidence.

Essential Duties and Responsibilities:
  • Work closely with cross-functional colleagues from Medical Affairs, Clinical Development/Operations, Biometrics, HEOR, Regulatory Affairs, Safety, Commercial, and Market Access to ensure that the global medical strategy and data generation plan optimally addresses current and future needs. Collaborative with regional colleagues to guide and inform plans in alignment with local needs
  • Design, execution, and interpretation of Phase 3b/4 studies, Expanded Access Protocols, product registries, and other sources of real world evidence in collaboration with internal colleagues, clinical centers, vendors, and other external partners. Lead development of study protocols, CRF design and database development, ICF/patient authorizations, site initiation and data entry activities and development of analysis plans. Support development of physician and patient engagement plans, including web portals, advisory boards, and novel tools to encourage long-term data collection
  • Partner with Medical Affairs, Regulatory Affairs and Market Access on outcome measures and data elements to monitored within registries and other real-world evidence studies
  • Partner with Patient Advocacy to develop studies to understand the patient and caregiver perspective around burden of disease and treatment outcomes
  • Support the development of criteria and processes for Externally Sponsored Research (ESR) studies; collaborate with Field Medical Affairs and investigators to provide input on study design and budgets
  • Collaborate with external study investigators, patient groups, and other consortia to maximize synergies in development of and access to complementary data-sets
  • Collaborate with colleagues in Medical Affairs to ensure all communications are aligned with the medical strategy to facilitate patient access to treatments


Qualifications:
  • MD, PhD or PharmD required
  • 8+ years of pharmaceutical industry or medical research experience (e.g., medical affairs, clinical development)
  • Prior experience in clinical trial design
  • Knowledge of statistical methods and regulatory requirements in clinical trials and real-world evidence protocol design
  • Experience assessing, utilizing, and/or developing and validating patient- and clinician-reported outcome measures
  • to assess patient perspectives, preferences, and burden of illness
  • Demonstrated ability to build credible professional relations with Key Opinion Leaders to enhance Registry enrollment and publication plan
  • A strong understanding of study initiation and championing ideas/projects, with an ability to readily examine and understand issues from multiple perspectives
  • Ability to interact internally and externally to support advancing Medical Affairs-directed research independently with minimal supervision
  • Flexible, adaptable, self-motivated, able to prioritize, and able to manage/progress a large volume of work with minimal supervision individually and as part of a cross-functional team
  • Demonstrated problem solving abilities and strong organizational skills; comfortable picking up new skills, and working in a flexible, dynamically changing and fast-paced environment
  • Excellent verbal & written communication skills, as well as exemplary interpersonal skills working with cross-functional internal teams, patients, researchers, clinicians and other stakeholders
  • This position is based at GBT headquarters in the San Francisco Bay Area


Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.