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Genmab · 1 day ago

Associate Director, Evidence Generation

Princeton, NJ

Full-time

Hybrid

Lead/Staff, Director/Executive

$171K/yr - $257K/yr

8+ years exp

Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. The Associate Director, Evidence Generation will oversee Medical Affairs Evidence Generation projects, manage Investigator-Driven Programs, and collaborate with cross-functional teams to ensure compliance and successful execution of project goals.

BiotechnologyHealth CareManufacturingMedical

Culture & Values

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

Qualification

Investigator-Sponsored trialsOncology knowledgeProject managementBudgetingMetrics analysisAnalytical skillsCollaborationAttention to detailOrganizational skillsCommunication

Required

Bachelor's or Master's or Advanced degree in a scientific discipline

8+ years of relevant experience in pharma/biotech industry, preferably in Oncology; Minimum of 3 years of experience in Investigator-Sponsored trials (ISTs) and/or Managed Access Programs (Individual and Protocol)

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