Genmab

Associate Director, CRS

Genmab

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $160,560 - $240,840 per year

Job Level

Senior

About the role

  • Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds
  • Works closely with Medical Director and Medical Program Lead (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)
  • Authors components with Medical Director and reviewer 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)
  • Contributes 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
  • 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 (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
  • Perform training at Investigator meetings, CRO/CRA training, SIVs as warranted
  • Provide mentoring to junior level Clinical Research Scientists

Requirements

  • PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
  • Minimum of 8 years of experience in clinical research with at least 4 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
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 analysisproject managementoncology drug developmenthematology drug development
Soft Skills
communication skillsinterpersonal skillsmentoringteam collaborationpresentation skillsleadershiporganizational skillsproblem-solvingtrainingstakeholder engagement
Certifications
PhDPharm DMS