Associate Director, CRS

Role Overview

• 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