The RoleAs a Senior Clinical Research Scientist, you will be in the Medical department and responsible to contribute 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. You will report to Director, Clinical Research Scientist.Responsibilities- Lead or co-lead 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
Qualifications- 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/hematology drug development experience is a plus
- Proven skills from working in a project oriented matrixed team environment
- Excellent oral, written and interpersonal (communication) skills
- Ability to travel, as needed
This role is located in Princeton NJ and is hybrid.
For US based candidates, the proposed salary band for this position is as follows:
$144,160.00---$216,240.00
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 discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 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
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
