We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood.
The Global Senior Director of Medical Affairs (GDMA) for Melanoma coordinates development of the Global Scientific and Medical Affairs Plans for assigned asset(s). The GDMA contributes substantially to and is a valued co-strategist on the Global Franchise Team and assigned Product Development (Sub-) Teams. The GDMA contributes to Life Cycle Management decisions. In addition, the GDMA leads the Medical Affairs input into the integrated data generation plans spanning outcomes research, post-registration company-sponsored studies and areas of interest for the investigator-initiated study program. The GDMA chairs the Global Medical Affairs Teams of Regional Directors Medical Affairs and other medical functions, synthesizes their medical insights from the regions and maintains an updated summary of the execution of the Medical Affairs Plans. The GDMA builds trust with the external scientific community via peer-to-peer engagement with scientific leaders, research and educational collaborations and publications. The GDMA executes global input meetings with Scientific Affairs to remain on the leading edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory, reputational, ethical, and other asset management issues.
Asset Management & Business Leadership
•-Consolidate actionable medical insights from all regions that help inform company decisions-
•-Coordinate development of Medical Goals and Strategies that address asset value proposition, insights from affiliates and regions, and clinical and value evidence gaps.-
•-Translate these Goals and Strategies into research, data analysis, scientific communication, educational , and other tactics and solutions that improve patient outcomes and enhance access, including digital solutions, patient and customer programs-
•-Contribute substantively to and be a valued co-strategist on asset cross-functional meetings: Franchise Teams, Clinical, Value-Evidence, Risk Management, and Commercial Product Development Subteams, Publication Teams
•-Inform our Company’s Life Cycle Management decisions leveraging patient and healthcare country insights
•-Support business development assessments by validating unmet medical needs, reviewing asset data (through a medical affairs lens), and recommending required medical affairs resources.
•-Support- integrated data generation plans , and co-develop clinical and outcomes research programs with cross-functional R&D and Observational Research colleagues that address life cycle management needs. Advise on areas of interest for the Investigator-Initiated Study Program.
•-Execute on and quickly adapt portfolio of tactics to life-cycle stage and business realities (i.e. prompt deployment of new information to the field medical staff, identify data analysis needs, and publication needs)
•-Lead medical affairs coordination in alliances that our Company may have with other pharmaceutical companies Scientific & technical Leadership
•-Communicates both scientific and business needs credibly and effectively across a variety of internal and external stakeholders at all levels, including external scientific leaders and key decision makers
•-Contributions at MISP and Sponsored Protocol Review Committees
•-Builds trust with the external scientific community via peer-to-peer interactions, research and educational collaborations, interactions with global scientific societies and health organizations, publications, or other
•-Develop and execute global advisory boards (with Scientific Affairs) and expert input forums to inform Life Cycle Management decisions
•-Develop and execute global symposia and educational meetings. Work with Regional Directors Medical Affairs for regional symposia and meetings.
•-Participate in and contribute significantly to professional organizations, academic or regulatory working teams Asset Regulatory Management
•-Successfully collaborate and lead resolution of Regulatory, Reputational (i.e. Public Relations), Compliance and other Asset issues management
Management Leads Global Medical Affairs Team of Medical Affairs colleagues (including Regional Directors Medical Affairs and Medical Strategy Leads USA and Japan) assigned to asset(s).
Education Minimum Requirement: MD, PhD or PharmD is required (MD preferred); recognized expertise through 5+ yrs. clinical and/or research experience (incl. publications) in therapy area (clinical experience is desirable)
Required Experience and Skills: 5+ years pharmaceutical (or related) industry experience in international role- with proven track record of contribution to medical, clinical or commercial strategies is required
Strategic thinking, specifically related to the development of Medical Affairs Goals and Strategies that address asset value proposition, and clinical and value evidence
Experience in clinical development or outcomes research is desired
Customer expertise, having a scientific leader network, and successful interactions with- key stakeholders (public groups, government officials, medical professional organizations) in therapy area.-
Proven ability to effectively influence company decisions
Proven ability to effectively communicate (written and oral) scientific and business information, both, to a variety of audiences including company management, scientific leaders and lay audiences.
Effective interpersonal and teamwork skills
Proven track record of translating strategies into tactics that are executed and completed
Strong prioritization skills and ability to understand how decisions fit into the broader context of corporate strategies
Track record of getting results in a matrix environment.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R238733
About the roleLocation: This position will be located at the East Hanover, NJ site and will not have the ability...
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