Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Associate Director leading clinical trials in therapeutic areas for innovative cancer treatment. Collaborating with cross-functional teams on clinical development strategy at Genmab.
Responsibilities
- Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds
- 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)
- 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 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
- Perform 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 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
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