Medical Affairs leader for assigned compound/s and /or project/s under the leadership of the GMA Franchise head. The Senior Director, GMA Oncology-ADC 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 Affairstrials 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 but not required
- 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
- More than 5 years of experience in pharma at local ,regional and/or Global level
- Can effectively manage and optimize resources and budget to meet business needs; have excellent project management skills
- 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,
- Provide training to external and internal customers,
- Define publication strategy and contribute to publication planning
- 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)
- 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
- Have excellent communications skills and ability to convey complex scientific and clinical concepts simply and effectively