Biotech Epidemiology Jobs (NOW HIRING)

Job Description

Under the general direction of the Associate Vice President in Vaccine/Infectious Disease (VID), Epidemiology, the Senior Director, Epidemiology has lead management and oversight responsibility for epidemiologic activities conducted by epidemiologists of their team on assigned products of our Company/indications and provides broad leadership and direction on scientific and operational aspects of epidemiologic research. The primary focus of this position is VID.

Key responsibilities include but are not limited to the following:

1. Has overall responsibility for management and scientific oversight of a team of epidemiologists focusing on Respiratory Disease, as well as Hospital Specialty Medicine therapeutic areas (TAs). In specific:

• Makes key epidemiologic decisions and is accountable for deliverables (strategies, plans, timelines, and reports) and for study budgets for the team.
• Solves operational and cross-functional issues (study execution, resourcing, personnel matters, cross-divisional coordination) and ensure deliverables are completed on schedule and within budget.
• Provides expert advice and guidance on the scientific and operational aspects of primary sample and data collection/natural history studies that are unique in Vaccine/Infectious Disease TA to support the clinical programs.
• Leads people management responsibilities: recruit, assign projects, allocate resources, conduct performance management, approve expenses, and provide coaching, mentoring, and professional development for epidemiology staff.
• Maintains and enhances the group's external scientific reputation by publishing, presenting at conferences, peer-reviewing journals, and participating in academic or consortia activities (teaching, supervising trainees) as appropriate.

2. Provides guidance to team members on the overall program-wide epidemiology/real world evidence (RWE) strategy and ensure that the strategy aligns with the program's clinical, regulatory and HTA strategies. The responsibilities include, but not limited to the following:

• Sets epidemiology strategy at the product/indication level, aligning Epidemiology strategy plans and safety/effectiveness evaluations with overall therapeutic area strategy and regulatory requirements.
• Reviews regulatory documents, reports, and scientific publications for assigned TAs to ensure accuracy, consistency, and alignment with company strategy and regulatory expectations.
• Provides expert scientific and regulatory guidance during product development and post-approval phases, including interpreting results, advising on regulatory submissions and responses, and participating in meetings with regulatory agencies, external scientific or industry consortia as needed.
• Track records of identifying opportunities and proposing innovative/advanced methodology to leverage RWE to support clinical development and regulatory decisions

3. Proven ability to build strong, productive relationships with counterparts across clinical development, safety/pharmacovigilance, regulatory affairs, outcomes research, medical affairs, commercial, and external partners. Actively socializes epidemiologic strategies and insights, secures stakeholder buyin for study design and evidence generation, and leverages these partnerships to expand the team's influence, resources, and impact across programs. Specifically,

• Translate epidemiology needs into business terms to obtain resourcing, data access, and operational support from partner functions.
• Identify and cultivate executive sponsors and key opinion leaders network to champion epidemiology initiatives and facilitate escalation when needed.
• Share study findings and methodological rationale in stakeholder forums to anticipate concerns and secure consensus before key decision points.
• Mentor team members on stakeholder management best practices and involve them in crossfunctional meetings to build internal credibility.

Education Minimum Requirement:

• Required: PhD in Epidemiology with 8 or more years of relevant work experience.
• Preferred: PhD in Epidemiology (or related field) or MD degree with additional research training in Epidemiology.

Required Experience and Skills:

• Minimum of 8 years of relevant work experience preferably in the pharmaceutical or biotech industry
• People management experience
• Extensive experience in the successful direction of large epidemiologic projects; broad knowledge and experience in the application of epidemiologic approaches to problems in the Pharmaceutical or Biotechnology industry; and record of research publications in peer-reviewed journals
• Molecular epidemiology training/background
• Creative problem-solving ability and excellent communication skills (oral and written)
• 5% Travel

Preferred Experience and Skills:

• Experiences in designing and conducting relevant epidemiologic biomarkers/natural history studies and activities
• Expertise and experiences using innovative/advanced methods to generate RWE supporting clinical development and regulatory decisions

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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:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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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.

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