Associate Director, Clinical Research Scientist

At Genmab, we are dedicated to building extra[not]ordinary® 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!

AD, Clinical Research Scientist

Responsibilities

Serve as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including clinical trial implementation, and oversight of all aspects of clinical development) working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables

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 with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (i.e., protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) 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 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 charters and coordinate internal/external committee meetings including presentation preparation (i.e., Dose Escalation, DMC, Steering Committee, Safety)

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

Guide and mentor junior level Clinical Research Scientists

Qualifications

PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline

Minimum requirement: 8+ years of experience in clinical research with at least 4 or more years of drug development experience (preferably in oncology/hematology)

Significant experience working in a project-oriented matrixed team environment

Proven performance in earlier role/comparable role

Proven experience working in teams

Ability to work successfully under pressure in a fast-paced environment and with tight timelines

Ability to be proactive, enthusiastic and goal orientated

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK--
- The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

Benefits

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

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…