Reporting directly to the EVP & Chief Medical Officer and with joint accountability to the WW President, Diabetes Care (DC), the VP, Medical Affairs provides strategic and medical/scientific leadership for COMPANY DC, worldwide. The position has overall responsibility for the safety and efficacy of all products within the business. The role ensures strategic and operational excellence of the Medical Affairs function and its members on a global basis for this business unit. This individual will be responsible for, and management of the team of Medical Affairs professionals who contribute to product ideation, concept development, product validation and qualification, legal and regulatory compliance, demonstration of product value, stakeholder education and risk/benefit assessments throughout the product life cycle.
The VP, Medical Affairs is a member of the WW Diabetes Care Leadership Team (DC LT), the Diabetes Care Portfolio Decision Team (DC PDT), the Diabetes Care Innovation Council (DC IC), and the COMPANYX Medical Affairs Leadership Team (MALT), including the CCDRB (Clinical Claims and Data Review Board).
The VP, Medical Affairs needs to have strong strategic and operational experience with clinical trial strategy, design and execution, demonstrated productivity in peer-reviewed publication and public speaking/presentation, as well as external KOL engagement. It is also very important for this leader to be a proactive contributor to the business by working closely with R&D, Strategic Marketing, and Business Development to foster innovation within Diabetes Care. The VP MA will build and maintain a high-functioning department with one or more physician members with successor potential, and develop talent within the MA function in an ongoing manner.
As a member of the WW DC LT, contributes to development of overall worldwide business strategy.
Works with the DC LT to determine strategy for new product development, prioritization of projects and resource management for the business.
Ensures understanding and support of DC WW strategy by all MA associates.
As a member of the WW DC LT and MALT, may lead Business Unit or COMPANYX Medical Affairs KDGs (Key Driver Goals).
Leads MA activities of innovation and new product development to include concept ideation, interaction with cross functional development teams, and assessment of clinical evidence requirements to meet regulatory, HEOR, safety and efficacy criteria.
Oversees consultation / interaction with associates from Global Clinical Development (GCD) to ensure appropriate clinical trial designs for both new and existing product development. While GCD is responsible for protocol development and study execution, DC MA ensures proper study design, analysis, interpretation, and publication / presentation of study results to maximize value to the business.
Reviews and approves proposals for IIS (Investigator-Initiated Studies).
Determination of the safety and efficacy of both new and existing products for DC. Reviews all regulatory submissions to ensure adequacy of support for all claims pertaining to the safety, effectiveness, and clinical performance of all products.
Determining whether there exist any adverse health consequences for any products that DC manufactures both during development and when marketed, through formal Risk Assessment procedures (FMEAs, SAs, HHEs, etc.).
Provides guidance to MA staff in all worldwide DC businesses/regions to ensure success in clinical trials for product registration and determination of safety and efficacy for marketed products.
Ensures appropriate input to the product teams for determining the potential clinical utility of any product under development by the Unit.
Works in close association with the VP of R&D and any research or other DC business groups involved with the exploration of potential new technologies for both core and OTHC (Outside The Home Court) products/services.
Provides senior-level clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world.
Ensures MA support to the worldwide Sales and Marketing departments.
Builds effective connections, interactions and collaborations with clinical investigators and Key Opinion Leaders (KOLs) at a peer-to-peer level, worldwide.
Represents COMPANY DC MA to professional societies (such as ADA, JDRF, AACE, EASD) and at medical and scientific meetings and seminars, often by invitation.
Keeps abreast of trends in health care delivery, diagnosis and treatment of human disease, especially as these relate to diabetes.
Experience & Education:
Actively U.S.-licensed physician with a Medical Degree (M.D., D.O. or equivalent) and with at least 10 years of experience in clinical medicine, including significant capability in clinical investigation. Seven or more years’ experience in the Medical device/bio-pharmaceutical industry strongly preferred.
Demonstrated record of peer-reviewed publications and a regional or national reputation in diabetes. Ability to qualify for at least Assistant professorship at an academic medical school, and for attending privileges at an academic teaching hospital highly desired.
Credible and compelling public speaker – often as the “face” of the DC business to other health care professionals and medical organizations / institutions.
Management/business experience desired to include talent management and budget accountability.
An active New Jersey medical license is also desirable to allow participation in the free diabetes clinic offered to associates at COMPANY, Franklin Lakes.
Strong preference to those who are Board-certified in Endocrinology & Metabolism, with specialization in diabetes.
Global exposure and understanding of medical/clinical practice and medical industry practices within and outside of the US.
Knowledge and Skills:
Must have clinical knowledge obtained through medical education and medical practice. Needs significant knowledge of clinical trial design, statistics, and data analysis. Should have an understanding of Good Clinical Practices (GCP) and FDA requirements for clinical investigation.
Influencing Skills - Able to establish rapport, value and respect within a complex and highly technical environment internally, as well as with KOLs and other influential stakeholders, externally. Able to influence directly and indirectly. Able to initiate and effectively lead change efforts.
Interpersonal Skills - Able to establish and build close working relationships across a highly matrixed organization and with alliance partners. Strong personal credibility, written and oral communication skills. Accomplished in group, business and social settings, respected by professional peers. Comfortable and capable in a variety of cultures and skilled in working internationally.
Business Acumen – Able to demonstrate business acumen and maturity within a strong group in order to effectively manage internal and external relationships and gain credibility in the role.
Leadership Skills - Team oriented with the confidence, maturity and integrity to lead effectively. Self-directed with strong initiative; leads by example. Able to demonstrate the key capabilities of the COMPANY Leadership Standard.
Results and Action Oriented - Driven to excel and capable of inspiring others to excellence as well. Able to envision a winning future for the organization and help turn that vision into reality through strategic planning plus hands-on action. Accepts accountability for results of the MA team and provides clear direction with input from others.
Problem Solving Skills – Brings a high level of intellect and curiosity to work. Able to apply mature business judgment in making decisions. Creatively and effectively challenges the thinking of others. Capable and effective in negotiations. Able to see the cultural and personal implications of decisions and plan for them.
Willing to travel frequently, 25%: U.S., Canada and international, including EU-EMA, LatAm, and A-Pac.
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