Senior Clinical Research Scientist
Genmab
full-time
Posted on:
Location Type: Hybrid
Location: Princeton • New Jersey • United States
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Salary
💰 $144,160 - $216,240 per year
Job Level
About the role
- 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
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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementclinical development plan (CDP)regulatory submissionscase report forms (eCRFs)data managementmedical data review plan (MDRP)data analysispublications developmentproject managementoncology drug development
Soft Skills
communication skillsinterpersonal skillspresentation skillsteam collaborationleadershiporganizational skillstraining skillsproblem-solvingadaptabilitystakeholder engagement
Certifications
PhDPharm DMS