- Ascendis Pharma (Princeton, NJ)
- …focus/expertise in these areas is a major advantage. The candidate is expected to lead key strategic, cross-as well functional projects as part of the US Medical ... phase IV clinical programs including, patient registries, and oversight of investigator -initiated Studies (IISs) as well as Special access programs. The candidate… more
- Taiho Oncology (Princeton, NJ)
- …and commercial plans. Requires a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, scientific standards ... and meaningful differentiation for medical practice adoption. Performance Objectives: Lead the development of the Integrated Medical Affairs Plan (iMAP) and… more
- Merck (Trenton, NJ)
- …for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The Regional Medical Scientific Director serves ... Enhances the comprehension of the scientific foundations and goals of investigator -sponsored research + Identifies barriers to patient enrollment and retention… more
- Sumitomo Pharma (Trenton, NJ)
- …evaluation, motivation, and control of activities in alignment with the company's corporate strategies and objectives. + Lead cross-functional medical alignment ... post-launch activities related to Medical Affairs function. This individual will lead program coordination with Clinical Development leadership to ensure alignment… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …that supports global registration and commercialization of Gilead's products. You will typically lead a large team of direct and indirect reports. You will be ... of resources to support a fluid 'One Ops' workforce. You will lead and/or effectively engage in Clinical Operations, cross-functional and/or country or regional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in a perpetual state of compliance as follows: + Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... meetings or other relevant activities. + Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality Oversight… more
- Sumitomo Pharma (Trenton, NJ)
- …team and play a highly visible role internally and externally, and effectively lead and communicate with cross-functional team members to develop and execute the ... to Global/Sumitomo Pharma America Inc. R&D Strategy and other corporate functions. + Provide input to VP Medical...costs to keep within budget of Medical Affairs. + Lead , develop and mentor team members. + Specify, develop… more
- Sumitomo Pharma (Trenton, NJ)
- …internal company programs and external facing interactions. This job will effectively lead and communicate with cross-functional team members to share and gain ... to HCP stakeholders and healthcare payers. + Serve as a Medical Strategy lead for the Pfizer alliance for Women's Health, ensuring coordination and alignment of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …May review tables, listings, and figures (TLF) and CSR safety narratives + May lead the development and updates of the Investigator 's Brochure (IB): author the ... **Clinical Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Experts in Oncology including advisory boards, Congress activities, and investigator initiated studies, advocacy and sponsorships. Interact with investigators and ... For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees...and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities… more
- Bristol Myers Squibb (Princeton, NJ)
- …Area Heads / Directors within Medical Safety Review. Takes the global lead in assuring consistent application of work practices and processes. Delegates to ... input the development of the Reference Safety Information section of the Investigator 's Brochure; provides peer review for safety documents (RMP, IB, aggregate… more
- Merck (Trenton, NJ)
- …execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate directors. ... data generation studies with V&I Outcomes Research + Supports the Investigator -Initiated Study program + Leads talent review process and demonstrates follow-through… more
- Sumitomo Pharma (Trenton, NJ)
- …multiple specialist types in a complex care setting. This job will effectively lead and communicate with cross-functional team members to share and gain insights ... research and presents research concepts to internal Review Committee for Investigator Initiated Study (IIS) concepts and research protocols. + Leads internal… more