Senior Director, GMA Oncology, Biomarker & CDx

Location
Basking Ridge, New Jersey, United States
Posted
Oct 23, 2020
Ref
10446BR
Discipline
Science/R&D, Oncology
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The Senior Director, Global Medical Affairs (GMA) Oncology, Biomarkers & Companion Diagnostics (CDx) is a dedicated GMA expert to partner with the GMA Team Lead and cross-functional stakeholders in development of and input into GMA, clinical development, commercial, and market access strategic imperatives within the Oncology Therapeutic Area. The role also drives development and execution of GMA tactics related to Biomarker and CDx to support the assigned compound portfolio and business strategies.

Responsibilities:
  • Provides medical leadership in development of GMA strategies and tactics for assigned compound indications related to Biomarkers and CDx
  • Serve as a strategic partner to GMAT Lead/TA Directors in development of and driving execution of the GMA Plan to support the overall portfolio and business strategies related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement
  • Active contributor and member of the Global Medical Affairs Team (GMAT) to ensure alignment of global medical and cross functional strategies
  • Establish and maintain internal and external relationships, and represent GMA in stakeholder engagements to facilitate medical input and activities
  • Providing input, leadership, oversight and support for related strategies and initiatives of the R&D clinical development and Biomarker/CDx, Commercial and Market Access plans
  • Leads Biomarker and CDx medical readiness activities for market launches and life cycle management
  • Member of the GMA Evidence Generation Team
  • Serve as medical lead for select company-sponsored GMA evidence generating studies/projects and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders
  • Responsible for understanding biomarker/diagnostics regulatory requirements and keeping abreast of technical, scientific and medical information
  • Serve as a therapeutic area expert in biomarkers and companion diagnostics, including information from scientific journals and congresses, to alert GMAT and other relevant stakeholders of critical new information that may affect strategies/plans
  • Provide scientific & medical education to medical affairs staff, and other team members related to therapeutic area, biomarker, diagnostic and disease-specific information
  • Engage with key external experts, including oncologists, scientists, pathologists to identify relevant gaps and areas to be addressed in support of medical and market launch initiatives, including questions and topics to be addressed by Field Medical Affairs, Scientific Exchange, Congress Medical Information, and other relevant aspects, etc.
  • Gains strategic and planning alignment across regions and functions and supports review of local country/regional medical affairs activities when applicable
  • May support review of investigator-initiated studies (IIS) and serve as deputy compound lead in Global IIS Review Committee meetings
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Doctorate required: PhD or MD with relevant training
Required Skills
  • Must have oncology experience, specifically in solid tumors
  • 10+ years pharma, minimum of 5 years of (in-house) medical affairs experience, global preferred
  • Previous overall responsibility and accountability for multiple indications of one or more compounds and related GMA plan/budget for related MA activities
  • Demonstrated ability to lead and influence others internally and externally
    • Experience leading matrix medical teams (e.g. GMAT) and representing medical on cross-functional leadership teams (e.g. Global Product Team, Global Brand Team, etc.)
    • Relationships with key opinion leaders
  • Proven ability to manage multiple priorities at one time
Preference Skills
  • Knowledge of ADC or other biologics, or small molecules
  • Demonstrated experience working with an alliance partner company
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Job Title
Senior Director, GMA Oncology, Biomarker & CDx

City
Basking Ridge

Functional Area
Global Medical Affairs Oncology

State
New Jersey