Director Real World Evidence Scientist (Oncology)

Merck Group • $172K — $258K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Master's or PhD in Epidemiology, Public Health, Health Economics and Outcomes Research, or Biostatistics.
  • 8-10 years of RWE experience in CRO or pharmaceutical/biotech settings.
  • Strong experience in studies based on secondary data use (claims, EMR, registries).
  • Experience in primary data collection studies.
  • Knowledge of federated data networks (CPRD, Optum, IQVIA) and OMOP CDM or FHIR data standards.

Responsibilities

  • Develop and own the RWE strategy at program level; integrate RWE into clinical and regulatory strategies.
  • Lead cross-functional initiatives in PRWE and CMS.
  • Plan and manage outsourced deliverables to ensure high quality and timeliness.
  • Facilitate objective interpretation of results and internal communications for decision making.
  • Collaborate on RWE strategy in Integrated Evidence Plans with cross-functional teams.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO) policy.
  • Retirement contributions.
  • Additional perquisites may apply.
Full Job Description
Your Role:

The Director, Real World Evidence Scientist is a highly experienced scientific expert who develops and owns the RWE strategy at the program(s) level, leads PRWE and CMS cross-functional initiatives, and interfaces directly with Global Program Teams (GPTs) and sub-teams. This role provides deep scientific leadership for the RWE strategy for one complex/high-priority product or group of products - leading and executing end-to-end RWE activities, providing expert oversight of studies, and representing our organization externally - without formal line management responsibilities.

Key Responsibilities:
  • Develop and own the RWE strategy at the program(s) level; interface directly with Global Program Teams (GPTs) and the subteams to integrate RWE into clinical development and regulatory strategies.
  • Lead PRWE and CMS cross-functional initiatives
  • Ensure planning and management of outsourced deliverables are effectively performed to the highest quality and in a timely manner.
  • Ensure objective results interpretation and adequate internal communication in support of informative decision making at GPT, PST, and Senior Management level.
  • Lead and execute the RWE strategy for assigned product(s) without supervision. Provide leadership in the development of RWE strategy in Integrated Evidence Plans (IEPs) in close collaboration with cross-functional teams; ensure RWE generation needs are included in the IEP and secure budget for strategy execution.
  • Collaborate closely with development team functions (GPS, GRA, GMU, GVD, GCD) and commercial teams (Market Access, Marketing, GVAP) as well as within PRWE.
  • For one complex/high-priority product or group of products: adequately and timely design, plan, initiate, monitor, and finalize NIS (including protocol development and study report writing); peer review key documents (protocol, study report, briefing books for Health Authorities).
  • Ensure the identification and selection of fit-for-purpose RWD sources for given research questions; contribute to the RWD strategy of the assigned therapeutic area.
  • Solves complex or novel problems by analyzing research findings. Interprets critical internal or external business issues and develops innovative solutions to help sustain competitive advantage
  • Represent PRWE in cross-functional governance bodies; direct the RWE contribution for publications.
  • Represent Company in external interactions requiring RWE expertise; represent PRWE at international conferences and consortia, contribute to peer-reviewed publications, conference presentations and scientific communications.
  • Research and implement state-of-the-art RWE methodology; develop RWE standards focusing on efficient study designs to support sound R&D decision making.
  • Lead process improvement to gain efficiency in current SOPs/WIs, and develop new ones as needed; promote lean concepts; encourage and foster collaboration at all levels within PRWE.
  • Ensure methodological intelligence on appropriate regulations, guidance documents, and methodological developments; provide sound and up-to-date recommendations to NIS conduct.
  • Handle interactions with Health Authorities and manage difficult issues with limited supervision; represent the company during approval processes including defense of RWE aspects with regulatory agencies.
  • Provide high quality input to critical review assessments, expert statements, publications, and study proposals from internal and external sources.
  • Develop new processes and SOPs relevant for PRWE at Company and customize existing ones according to lean concepts.
  • Manage budget associated with program-level RWE projects; maintain overview of budget spend by functional and program budget.
  • Act as scientific mentor for less senior scientists within the function.


Who You Are:

Minimum Qualifications:
  • Master's or PhD in Epidemiology, Public Health, Health Economics and Outcomes Research, or Biostatistics.
  • 8-10 years of RWE experience in CRO, or pharmaceutical/biotechnology industry settings.
  • Demonstrated strong experience in studies based on secondary data use (claims, EMR, registries) across different healthcare environments (Europe, US, Asia).
  • Experience in studies based on primary data collection.
  • Knowledge of federated data networks (CPRD, Optum, IQVIA, TriNetX) and OMOP CDM or FHIR data standards.


Preferred Qualifications:
  • Strong methodological skills; medical/pharmacological/pharmacovigilance knowledge.
  • Experience in project management as a global RWE leader, preferably in multi-cultural environments.
  • Strong expertise in drug development, including interfaces and interdependencies of clinical development with other functions.
  • Experience in global regulatory and/or payer submissions and interactions.
  • Experience in at least one key therapeutic area (Oncology, Neurology & Immunology).
  • Excellent understanding of the regulatory environment and standards.
  • Track record of thought leadership (publications, conference presentations, advisory roles).
  • Experience with AI/ML applications in RWE, including NLP.
  • Experience with patient-reported outcomes (PROs) and health technology assessment (HTA).
  • Experience in budget oversight and vendor management in global organizations.
  • Knowledge of health equity and DEI principles in evidence generation.
  • Involvement in industry working groups, regulatory advisory committees, or professional society leadership


Pay Range for this position: $172,000 - 258,000
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

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Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

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Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

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Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

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Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

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Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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