16 ott - Bardi
Genmab
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 tempo pieno schedule is: DKK*******,**************,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 ****, 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 ****, 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.
Genmab is committed to protecting your personal data and privacy.
Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
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