Medical Director
Medical Director
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
At Genmab we are dedicated to building extranotordinary 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 Medical Director supports the Clinical Development Team including the Study Lead Disease Area Lead and Compound Medical Lead.
Responsibilities:
-Lead the assigned trials and participate in the development of the clinical development plan (CDP)
-Lead creation and 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 supporting registration market access and commercialization of the compound(s)
-Oversee safety of the drug including the safety aspects of patients in clinical studies and signal detection with support of the Safety physician
-Integrate and execute overall medical strategy of assigned clinical development programs; provide strategic medical advice on potential new projects (internal & external)
-Contribute to publication and clinical communication strategy in coordination with Scientific Communications; provide inputs to key external presentations
-Provide input and support for clinical plans and individual trial protocols
-Interact 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
-Contribute to medical department best practices standardization and to cross-functional process improvements
-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
-Support the development of other relevant documents that are necessary for the advancement of the product pipeline
-Serve as medical and technical resource for clinical issues raised by internal and external collaborators investigators consultants and contractors
-Contribute to medical deliverables: clinical development plans concept sheets briefing books and label and marketing application dossier
-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
-Participate in multi-function teams necessary for the advancement of the product pipeline
-Attend relevant congresses or other relevant fora to maintain up-to-date scientific/medical knowledge
Requirements:
-MD background with a minimum of 3 years of directly related industry experience within oncology or hematology
-Significant experience within hematology especially lymphoid malignancies.
-Proven ability to build and lead teams and inspire trust among colleagues
-Experience representing team and organization in a variety of internal/external settings
-Experience training and managing team members
-Proven performance in earlier role/comparable role
About You
You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can 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 maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.
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Required Experience:
Director
Employment Type
Full-Time
