Senior, Clinical Research Scientist

Genmab•Plainsboro Township, NJ

About The Position

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! Role This position contributes to the 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. This may include 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.

Requirements

PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
Minimum of 6 years of experience in clinical research with at least 3 or more years of drug development experience
Prior oncology drug development experience
Solid Tumor experience preferred
Late Phase experience preferred
Proven skills from working in a project oriented matrixed team environment
Excellent oral, written and interpersonal (communication) skills
Ability to travel, as needed

Responsibilities

Lead, co-lead, or support one or more clinical trial(s) in a therapeutic area for one or more compounds.
Works closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted)
Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
In collaboration with the Medical Director, contributes to the development 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)
Participates 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
Contributes medical input for country/site selection, feasibility assessment and engage in KOL interaction
Prepare charters and coordinate 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
Provide input for the development of publications in coordination with Scientific Communications
Contribute to training at Investigator meetings, CRO/CRA training, SIVs as warranted

Benefits

401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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