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The Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical Affairs Plans for Oncology Pipeline Assets. The GDMA contributes substantially to and is a valued co-strategist on the Global Franchise Team and assigned Asset Development (Sub-) Teams. In addition, the GDMA leads the Medical Affairs input into the integrated data generation plans spanning outcomes research, peri-registration company-sponsored studies and areas of interest for the investigator-initiated study program. The GDMA will interact with other TA groups (both at the global and regional level), as well with other relevant internal stakeholders - early development teams, commercial, CORE, Scientific affairs, Market Access, among others – to develop and implement medical affairs plans for the applicable assets. 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 Group Input Meetings (advisory board meetings) in partnership with Executive Directors of 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.

This is a headquarters-based position in Our Company Research Laboratories Global Medical and Scientific Affairs (Research & Development (R&D) GMSA) but additional locations can be considered.

Primary Responsibilities:

Asset Management & Business Leadership

  • Coordinate development of medical goals and strategies that inform and demonstrate scientific & clinical value and address insights from affiliates and regions including clinical and value evidence gaps. Consolidate actionable medical insights from all regions that help inform company decisions.

  • 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, Outcomes Research, Risk Management, and Commercial Asset 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

  • Develop/support initiatives to improve internal education about the pipeline agents and specific projects under the Innovative Strategy group

  • Contributions at MISP and sponsored Protocol Review Committees (PRCs)

  • 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 relevant stakeholders

  • Develop and execute global Group Input Meetings (advisory board meetings) in partnership with Executive Directors of Scientific Affairs 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

  • 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-related medical, clinical and scientific value requirements for most geographies

Management

  • Participate during relevant Global Medical Affairs Team (GMAT) (including Regional Directors Medical Affairs and Medical Strategy Leads) related to assigned to asset(s). Collaborate with the relevant TA teams, either at global and regional level for the execution of the relevant medical plans associated with pipeline compounds and Innovative Strategies projects.

Education Minimum Requirements:

  • MD, PhD, PharmD required; recognized expertise through 3+ yrs. clinical and/or research and/or medical affairs experience in oncology (clinical experience is desirable)

Required Experience and Skills:

  • 3+ years pharmaceutical (or related) industry experience with proven track record of contribution to medical, clinical and scientific strategies is required

  • Strategic thinking, specifically related to the development of Medical Affairs Goals and Strategies that inform and demonstrate scientific & 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 strategy

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

No relocation

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/24/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date:09/24/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID:R311181