Associate Director - Evidence Generation

Genmab

Copenhagen or Utrecht,

The Role & Department

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.

Key Responsibilities Include

Oversee successful implementation of 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.
Initiate, author, or contribute to SOP development, implementation, and training.
Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals.
Participate in process improvement exercises to drive operational excellence.
May represent the department at cross-departmental events.

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.
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.
Must have a demonstrated ability to successfully develop, implement, and manage Investigator-Driven Programs.
Must be able to resolve problems using national and international regulations, guidelines, and investigator interactions.

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.

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