At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The position serves as a key role in contributing to the scientific and medical expertise in a therapeutic area leading one or more clinical trials for one or more compounds in various stages of clinical development. This may include clinical trial and program implementation, and oversight of all aspects of clinical development working closely with the Medical Director/Medical Compound Lead and cross-functionally to effectively implement the global development strategy. In addition, this individual may be responsible for a program and the management of Clinical Research Scientists. You will be part of the Medical Department, US reporting to the Senior Director, CRS Program Lead.
- Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
- Author components and key reviewer of 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] to support registration and commercialization of the compound(s)
- Participate in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities).
- Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
- Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
- Prepare, coordinate and/or participate in internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees)
- Participate in the development and review of study plans and serve as a liaison to project teams and CROs
- Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
- Provide input for the development of publications in coordination with Scientific Communications
- Provides scientific and clinical leadership for Clinical Research Scientists including matrix management responsibilities as applicable
- PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
- Minimum of 10 years of experience in clinical research with at least 6 or more years of drug development experience
- Prior oncology/hematology drug development experience required
- Proven skills from working in a project oriented matrixed team environment
- Proficiency in leading teams and activities
- Excellent oral, written and interpersonal (communication) skills
- Ability to travel, as needed
For US based candidates, the proposed salary band for this position is as follows:
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
- 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