WW Associate Director, Medical Affairs

The Worldwide Associate Director, Medical Affairs, Advanced Diabetes Care (ADC) will serve as a key member of the BD Advanced Diabetes Care and Diabetes Care Medical Affairs Organization. Reporting to the WW Director, Medical Affairs, this position will lead evidence generation and medical strategy for respective platforms within Advanced Diabetes Care.
Key Responsibilities:
Clinical Studies/Evidence Generation
Responsible for developing a robust evidence generation plan for products within the Advanced Diabetes care portfolio. This includes designing clinical studies and overseeing end to end Corporate Clinical Development activities to ensure studies are optimally designed, on target, on time, within budget and completed with the highest level of integrity; observing all compliance requirements from design through conduct and post-study presentation / publication.
Responsible for authoring study synopses and partnering with the CCD, overseeing the completion of robust study protocols in an efficient manner.
Responsible for authoring / co-authoring initial drafts of abstracts and manuscripts for peer-reviewed publications. Alternatively, may direct such work by external medical communication companies / writers, and/or internal BD publication resources, as available.
Working with Global and regional Marketing, develop an annual evidence generation roadmap, including gap assessments and identifying and securing resources required to successfully complete the evidence requirements for a particular product.
Partner with external experts in order to optimize clinical study design and develop ongoing relationships with KOL investigators in the Diabetes therapeutic arena
Partner with corporate statistics and Corporate Clinical Development teams to ensure optimal study design, protocol and conduct
Leads the development of a comprehensive diabetes clinical investigation database within Advanced Diabetes care, aligned to evidence generation needs and roadmaps
Leads Investigator Initiated Study strategy and manages this process within Advanced Diabetes Care
Product Development & Support
Serves as the MA representative/lead on assigned core teams
Provides medical input and direction on product requirements
Supports innovation efforts, as appropriate, in identifying key unmet medical needs and possible solutions that may address these needs
Evaluates product risk and partners with Quality to establish robust risk assessments and hazard evaluations for a specified product
Engages external experts in providing insights and support as it relates to user requirements, clinician requirements and unmet medical needs
Medical Strategy and Market Development
Develops a comprehensive annual integrated medical affairs plan for a specified product / platform
Partners with HEOR, field medical outcomes lead and field-based MSLs to develop a robust market development strategy for pre-launch products and ensures these teams are provided with product and evidence-based training for the Advanced Diabetes Care portfolio
Partners with countries and regions to assess, understand and develop region and country level evidence roadmaps for ADC products
Develops a robust WW KOL engagement strategy for each product within the ADC portfolio
Presents at medical conferences as appropriate
MD or Pharm.D. is required. MS or PhD with strong relevant experience will be considered.
10 years of progressive experience in the pharmaceutical or medical device industry required.
Proven capabilities with clinical trial design and ability to interpret, critique, and to present study results are essential
Experience in working with KOLs to design clinical studies is also essential experience.
Experience in Diabetes; particularly Type 2 diabetes pharmaceutical or medical device experience is preferred. Experience with insulin delivery (injection/infusion) and/or injectable diabetes medication development is highly desirable, as is an understanding of Type 2 Diabetes treatment options including relevant clinical outcomes.
Experience in partnering with R&D and corporate clinical study groups is also highly desirable.
Experience and established relationships with Diabetes KOLs are required.
Clinical experience managing patients is also preferred.
Excellent presentation, interpersonal and communication skills (both verbal and written) are expected.

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