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  • Bernards, NJ 07920

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Senior Director, Global Medical Affairs Oncology – Rare Disease

Daiichi Sankyo, Inc. • Bernards, NJ

Posted 21 days ago

Job Snapshot

Other Great Industries
Health Care, Pharmaceutical

Job Description

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary:

Medical Affairs leader for assigned compound/s and /or project/s under the leadership of the GMA Franchise head. The Senior Director, GMA Oncology- Rare Disease will develop the GMA strategy and execution of the Global Medical Affairs plans including Launch Readiness and Life cycle management.

  • Responsible for the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plans including strategy related to evidence generation, scientific exchange and data communication, and stakeholder engagement. For the assigned compound/projects, leads Launch Readiness activities and life cycle management from a medical perspective.
  • Lead or co-leads GMAT, to gain strategic and planning alignment across regions and functions. Member of Pub, clinical, safety, RWE sub teams, GBT, GPT including review and discussion of Local/Regional Medical Affairs trials concept sheets when applicable.
  • Provides Medical leadership to Medical Study Teams for DSI sponsored GMA trials
  • Manages all medical aspects and drives execution for assigned GMA clinical trial projects in collaboration with other global line functions, assigned Clinical Trial Operation teams, and regional/country medical associates.
  • Medical support for market access discussions.
  • Leads review of investigator-initiated studies (IIS), within Global IIS review Committee, for assigned projects(s).
  • Supports medical training, medical education, and commercial activities in alignment with the Global Brand Team. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations
  • Collaborates across functions to achieve approval of key scientific communications and medical information documents within legal and compliance regulations
  • Provides medical leadership in interactions with key external stakeholders e.g., Plan advisory boards, under supervision of GMA Franchise Head , manage investigator interactions, congress activities; Peer to peer discussions with key TL /investigators Develops MSL training plan for indication, leads or participates in training programs.
  • Oversight of timely training or communication of emerging data (internal or competitive), congress updates, and development program highlights to CF stakeholder.
  • Provides input into and reviews abstracts, manuscripts, press releases, promotional materials, educational slide decks, medical response documents.
  • Responsible to efficiently manage budgets and resources for DSI Sponsored and GMA supported activities, in collaboration with GMA Franchise Head

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

  • PhD, PharmD Required, MD strongly preferred;
  • Advanced knowledge in medical/scientific area (Oncology) required.
  • Demonstrates strong scientific expertise within assigned therapeutic area(s) within the franchise, and strategically leads planning and execution for global medical affairs content deliverables of the plan across a global matrix organization
  • Builds strong cross-functional and global relationships- Interacts with regions, MKT Access, HEOR, Brand team.
  • Have expert operational knowledge and experience in clinical trial design and all stages of clinical trial conduct (Trial design, Start-up, Execution, Analysis, Reporting)
  • Have an excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area
  • Have strong knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products
  • Effectively engage external stakeholders across a broad range of audiences and activities; Build strong internal and external relationships with diverse stakeholders that maximize alignment and organizational effectiveness
  • More than 5 years of experience in pharma at local, regional and/or Global level
  • Medical expertise to ensure successful product launches across functions and life cycle management
  • Lead and manage different activities: - Sponsored trials, -Review IITs, -Implement patient access programs,
  • Review promotional materials; Define publication strategy and contribute to publication planning; Review publications
  • Provide training to external and internal customers,
  • Build and lead high performing cross-functional teams collaboratively; Expertly lead and manage large, cross-functional, global teams to achieve high performance
  • Can effectively manage different and diverse projects (clinical program, publication, medical education, Advisory boards); Have excellent project management skills
  • Display enterprise leadership in all aspects of the role by gaining alignment across functions and divisions
  • Integrate medical expertise with commercial perspective
  • Expertly manage ambiguity and highly complex situations
  • Maintain an external focus to optimize and maximize treatment options and compound life cycle management
Ability to travel up to 30% either global or domestic travel
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 ID: 9512BR
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