Senior Principal Scientist, Medical Affairs, Global - Head & Neck Cancers (Rahway, New Jersey)

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Job Description

The Sr. Principal Scientist, Global Director of Medical Affairs (GDMA) for Head & Neck Cancers/melanoma, coordinates the development of the Global Scientific and Medical Affairs Plans for their 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 advisory boards (with Scientific Affairs) and expert input forums 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, Rapid Response Teams
• Inform 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
• Substantive contributions to labeling committees. Ensure labels contain fair-balanced claims supported by data and supportive of asset value proposition requirements for most geographies

Management

• Leads Global Medical Affairs Team (GMAT) of Medical Affairs colleagues (including Regional Directors Medical Affairs) 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 communicate (written and oral) scientific and business information, both, to a variety of audiences including company management, scientific leaders and lay audiences.
• 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

Required Skills:

Adaptability, Advisory Board Development, Anatomic Pathology, Biomarker Development, Clinical Development, Consultative Approach, Data Analysis, Decision Making, Healthcare Education, Medical Knowledge, Medical Marketing Strategy, Professional Networking, Scientific Communications, Stakeholder Engagement, Strategic Planning

Preferred Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$282,200.00 - $444,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ]]> <