(Senior) Director, Epidemiology

The Role

This position will be responsible for developing and executing robust epidemiology plans for Genmab product portfolio and pipeline in alignment with clinical development, global drug safety and pharmacovigilance and commercialization strategy.

As the lead for epidemiology function, this role will report into Head of Center for Outcomes Research, Real World Evidence and Epidemiology and will build out the strategic vision and functional capabilities for the group as the company portfolio grows.

This is a hybrid role that requires being onsite in Princeton, NJ 60% of the time.

Responsibilities

Set strategy, vision, and high-level processes within the epidemiology functional area.

Accountable and responsible for epidemiology research plan and study execution including protocol development, cross-functional alignment, execution, and delivery.

Partner with Global Drug Safety and Pharmacovigilance and Compound Development Teams to interpret and refine potential safety signals during drug development through signal evaluation techniques using epidemiologic methods.

Partner with RWE Analytics team and external vendors to implement analyses from registries, post-approval safety studies and other observational studies to contextualize safety events.

Accountable for epidemiology content in regulatory and safety deliverables, including benefit-risk assessments, Risk Management Plans, orphan drug applications, pediatric investigation plans, DSUR and PBRER.

Accountable for strategy and conduct of regulatory agency required epidemiologic studies such as PASS, PAES, PMR, DUS in partnership with Global Drug Safety and Pharmacovigilance .

Evaluate the efficiency of REMS in support of clinical development, regulatory filings, and post marketing requirements.

Represent CORE on cross-functional teams, including Safety Committee.

Lead development and maintenance of relevant SOPs and Working Instructions for epidemiology functions.

Develop tools / guidance that provide Genmab with rigorous assessment of the incidence and prevalence of disease targets using literature reviews or extrapolation of estimates using disease registries and natural history studies.

Develop tools / guidance that provide Genmab with rigorous assessment of factors enabling actionable diversity action plans.

Provide oversight to selection and execution of external vendors in literature surveillance related to pharmacovigilance activities.

Lead planning and execution of all CORE epidemiology projects and budgets to target.

Serve as a methods expert on observational study design within CORE and provide scientific oversight to Observational Research Protocol Committee.

Stay current with emerging guidance from various regulatory authorities on the design of observational studies and US, EU, and international regulatory and pharmacovigilance requirements.

Drive engagement within team through guidance / mentorship and manage a team of epidemiologists as company grows.

Requirements

Graduate (PhD or Masters) degree and / or relevant work experience in epidemiology, health services research, public health, health policy.

Minimum requirement : 10+ years in the pharmaceutical industry or regulatory setting in the direct conduct of epidemiology studies

Extensive experience with epidemiologic research methods, including study design and analysis for signal evaluation.

Demonstrated research accomplishments as evidenced by a history of peer-reviewed publications.

Experience working with regulatory processes in key markets in safety evaluations.

Prior experience in building external connections with peers, regulatory communities across regions, and external networks.

Proven performance in earlier role / comparable role including strategic oversight and strategic stakeholder management across levels internally and externally.

Experience directing teams directly / indirectly in a leadership capacity with focus on both achievement of objectives as well as critical skill-building preferred.

For US based candidates, the proposed salary band for this position is as follows :

$,.00 $,.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location.

Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.

Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.

Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.