Associate Director, Evidence Generation

Genmab • Plainsboro Township, NJ

5d • Hybrid

About The Position

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role
The Associate Director, Evidence Generation will play a key role in executing Medical Affairs Evidence Generation projects for both approved and pipeline products. This position will be responsible for overseeing a molecule program as well as performing operational aspects of Investigator-Driven Programs: Investigator-Sponsored trials (ISTs), Collaborative Research Trials (CRTs), Managed Access Programs (Individual and Protocol) and other initiatives within Medical Affairs.
Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.

Requirements

• Bachelor's or Master's or Advanced degree in a scientific discipline
• 8+ years of relevant experience in pharma/biotech industry, preferably in Oncology
• Program and/or Project management experience with leading teams, study protocols or programs preferred
• Experience managing global ISTs and/or Medical Affairs initiatives preferred
• Therapeutic knowledge in oncology (e.g. lymphoma, breast cancer, solid tumors), pharma and biologics is a plus
• Experience with budgeting and contracting
• Experience producing and analyzing metrics/reports
• High attention to detail, strong analytical and organizational skills
• Excellent ability to prioritize workload
• Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data from sponsored or independent non-clinical and clinical studies and articulate summary information in verbal and written form

Nice To Haves

• Therapeutic knowledge in oncology (e.g. lymphoma, breast cancer, solid tumors), pharma and biologics is a plus
• Program and/or Project management experience with leading teams, study protocols or programs preferred
• Experience managing global ISTs and/or Medical Affairs initiatives preferred

Responsibilities

• Oversee successful implementation of Investigator-Driven programs
• Successfully develop, implement, and manage Investigator-Driven Programs
• Execute formal review process for proposals, protocols, and amendments
• Facilitate review committee meetings and document decisions
• Drive operational timelines and key deliverables for the program or project
• Manage proposal lifecycle from submission to study closure
• Provide guidance and oversight for the successful management of all aspects of investigator-driven programs within designated program budgets and timelines
• Partner with cross-functional teams and alliance partners to manage, adjust, and revise project timelines/budgets as necessary
• Generate regular metrics and reports of program activities and present them to leadership and strategy team as needed
• Support field-based teams and MASL teams in executing project/program goals
• Work cross-functionally with internal teams which may include development, research, legal, finance, supply chain, and regulatory
• Independently manage ISTs including site coordination, document management, and drug shipment and payments
• Contribute to contract review and negotiations
• Communicate project status and issues and ensure project team goals are met
• Represent the department at cross-departmental events, as needed
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training
• Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals
• Ability to resolve problems using national and international regulations, guidelines, and investigator interactions
• Participate in process improvement exercises to drive operational excellence.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

What This Job Offers

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