Sr. Director, Epidemiology - Hematology

Merck • Boston, MA

1d • Hybrid

About The Position

Under the general direction of the AVP, Epidemiology, the Senior Director, Epidemiology has lead management and oversight responsibility for epidemiologic activities conducted by epidemiologists of his/her team on assigned company assets and indications and provides broad leadership and direction on scientific and operational aspects of epidemiologic research. The primary focus of this position is hematology. Key responsibilities include but are not limited to the following: Has overall responsibility for the management and scientific oversight of a small team of epidemiologists in hematology supporting multiple assets and indications. Provides guidance to team members on the planning, design, and execution of epidemiologic studies/ activities related to clinical development support; safety and effectiveness, including post-licensure commitments; endpoint strategy; and observational research methodology. Supervised by the Oncology therapy area AVP within the Epidemiology department. Reviews regulatory documents, study protocols and reports, and publications within assigned assets and indications to ensure scientific integrity and alignment with company strategies and plans. Makes key epidemiologic decisions and is accountable for deliverables (strategies, plans, timelines, and reports) and for study budgets for the team. Executes independently. In addition to team oversight responsibility, has asset-level responsibilities across relevant indications. Presents epidemiologic research plans and results to internal review and governance committees. Participates in interactions with regulatory agencies and health authorities such as FDA, EMA, CDC, WHO. Expert epidemiologic, regulatory, and leadership skills to set epidemiology strategy for assets/ indications. Has a proven track record of serving as the lead in the planning, conduct, analysis, and reporting of epidemiologic studies. Strong problem-solving skills for asset development strategy, regulatory strategy, scientific interpretation of results, and solving operational issues. Problem solving may also involve personnel matters and cross-functional/cross-divisional matters. Expert skills in people management, mentoring, collaboration, teamwork, multi-tasking, and communication. Responsible for performance management, expense report approval, recruiting, project assignments, resource allocation, employee development, and coaching/mentorship. Contributes to our company's prestige by maintaining recognition as an expert in his/her field; may publish independent scientific research in leading journals, participate in and present at scientific organizations and meetings, and serve as a peer reviewer for scientific journals. May participate in external strategic initiatives (e.g., DIA, PhRMA, BIO consortia) that are important to our company. May hold academic appointments, teach graduate courses, and supervise Ph.D. dissertations and post-doctoral fellows.

Requirements

• MA/MS in Epidemiology with 8 years of relevant work experience.
• 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
• Creative problem-solving ability and excellent communication skills (oral and written)
• Biopharmaceuticals
• Biopharmaceutics
• Clinical Development
• Data Management
• Endocrinology
• Epidemiology
• Executive Oversight
• Hematology
• Human Resource Management
• Methods and Tools
• Multitasking
• Pathophysiology
• People Management
• Regulatory Compliance
• Researching
• Stakeholder Relationship Management
• Strategic Planning
• Technical Advice

Nice To Haves

• PhD in Epidemiology (or related field) or MD degree with additional research training in Epidemiology.
• Training and experience in leading and conducting oncology epidemiologic studies and activities with an emphasis on hematology and biomarkers are preferred for this position.

Responsibilities

• Has overall responsibility for the management and scientific oversight of a small team of epidemiologists in hematology supporting multiple assets and indications.
• Provides guidance to team members on the planning, design, and execution of epidemiologic studies/ activities related to clinical development support; safety and effectiveness, including post-licensure commitments; endpoint strategy; and observational research methodology.
• Reviews regulatory documents, study protocols and reports, and publications within assigned assets and indications to ensure scientific integrity and alignment with company strategies and plans.
• Makes key epidemiologic decisions and is accountable for deliverables (strategies, plans, timelines, and reports) and for study budgets for the team.
• Presents epidemiologic research plans and results to internal review and governance committees.
• Participates in interactions with regulatory agencies and health authorities such as FDA, EMA, CDC, WHO.
• Contributes to our company's prestige by maintaining recognition as an expert in his/her field; may publish independent scientific research in leading journals, participate in and present at scientific organizations and meetings, and serve as a peer reviewer for scientific journals.
• May participate in external strategic initiatives (e.g., DIA, PhRMA, BIO consortia) that are important to our company.
• May hold academic appointments, teach graduate courses, and supervise Ph.D. dissertations and post-doctoral fellows.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director