Associate Medical Director, Utrecht

The Role We are looking for an experienced and dedicated Associate Medical Director to be a part of our team.

Responsibilities

Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)

Support/lead creation/review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] for registration, market access, and commercialization of the compound(s))

Oversee and develop clinical component projects including component studies, with guidance from (Sr.) Medical Director as appropriate

Support oversight of the safety of the drug, including the safety aspects of patients in clinical studies and signal detection

Support creation, integration, and execution of overall medical strategy of assigned clinical development programs

Contribute to publication and clinical communication strategy in coordination with Scientific Communications; provide inputs to key external presentations

Provide strategic input and development support for clinical plans and individual trial protocols.

Support interaction with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, as well as consideration of novel medical methods development and new potential targets

Support the development of case report forms, perform medical monitoring, liaise with investigators, and site personnel, perform preliminary and exploratory data analyses on clinical trials, author clinical study reports, provide input on publication materials, and participate in advisory boards

Contribute to medical input to preclinical development of candidate therapeutic antibodies

Drive and monitor quality of all clinical documents (e.g., Investigators’ Brochures, protocols, study reports, clinical components of regulatory submissions, safety documents) produced by CDT, with guidance from (Sr.) Medical Director as appropriate

Participate in multi-function teams necessary for the advancement of the product pipeline

Attend relevant congresses or other relevant forum to maintain up-to-date scientific/medical knowledge

Qualifications

MD background with a minimum of 2+ years of directly related industry experience (or medical specialty clinical practice) within oncology or hematology

Experience representing team and organization in a variety of internal/external settings

Scientific background and/or deep understanding of immuno-oncology and or clinical care of oncology patients strongly preferred.

Ability to represent the Company in a variety of internal and external settings.

Persuasive and effective in personal interactions at all levels of the organization.

Demonstrated success in teamwork within a matrix organization and ability to inspire trust among colleagues.

Innovative, flexible, resilient, and visionary with the ability to seize opportunities.

Ability to prioritize, respond to directives, and work in a fast-paced and changing environment.

Result and goal-oriented and committed to contributing to the overall success of Genmab.

Deep desire to make a difference.

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