Associate Director, Clinical Research Scientist

Genmab; Lombardia; Sur place; EUR 98 000 - 147 000; Plein temps

Avantages offerts par ce poste

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Résumé du poste

Genmab is seeking an Ad, Clinical Research Scientist to lead or co-lead clinical trials with close collaboration across Medical Director, cross-functional teams and CROs. The role emphasizes development of CDP, regulatory submissions, and scientific data interpretation.

The candidate should have 8+ years in clinical research, with 4+ years in drug development, preferably oncology/hematology, and a proven ability to work in a matrixed environment under tight timelines.

Qualifications

• PhD/Pharm D/MS or equivalent degree in medical/biological/pharmaceutical sciences.
• 8+ years of clinical research experience with 4+ years in drug development (oncology/hematology preferred).
• Experience working in a matrixed, project-oriented team environment.
• Proven performance in prior roles and in collaborative settings.
• Ability to perform under pressure in a fast-paced environment and meet tight timelines.

Responsabilités

• Lead or co-lead one or more clinical trials within a therapeutic area.
• Contribute to program strategy and clinical development plan.
• Author protocol, ICF, IB, safety updates, study reports, and regulatory submissions.
• Develop eCRF components and provide data management support.
• Lead data review, summarize efficacy and safety data for analyses.
• Provide medical input for country/site selection and feasibility assessments.
• Coordinate committee meetings and prepare presentations for Investigator meetings.
• Collaborate with project teams and CROs on study plans and governance.
• Prepare communications for Scientific Communications and publications.
• Mentor junior Clinical Research Scientists.

Connaissances

PhD

Pharm D

MS

Equivalent degree

Clinical research

Team collaboration

Work under pressure

Proactivity

Description du poste

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: DKK730.320,00---1.095.480,00

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 checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s 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 Genmab.com and follow us on LinkedIn and X.

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