Associate Director, Clinical Science
4 weeks ago
Study Strategy:
Develops and implements clinical study strategies to ensure successful trial execution. Collaborates with Biostats, Data Management, and Data Operations to design and implement data management plans, edit checks, and data quality listings. Reviews patient population and protocol compliance to ensure consistency with study strategy.
Study Planning and Execution:
Provides input on major milestones, clinical trial plans, and contingency planning. Analyzes and updates management on potential risks to study deliverables. Oversees recruitment and retention, establishing and implementing contingency plans for shortfalls. Consults and recruits members for Data Safety Monitoring Boards and adjudication committees.
Study Outputs:
Drafts responses to Institutional Review Boards and Health Authorities. Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK/PD measurements. Reviews emerging clinical data regularly and leads dose-escalation meetings. Performs quality assessments with Delivery Leads, reviewing tables, listings, and graphs before database lock and quality checking data.
External Collaboration:
Consults with internal experts and external Key Opinion Leaders, Ad Boards for protocol development. Provides input on Contract Research Organization/Associate Research Organization Statements of Work and Budget. Establishes effective communication between CRO/vendors/ARO.
Additional Responsibilities:
Occasional senior management interactions at meetings. Initiates contact with Key Opinion Leaders and prepares materials for KOL interactions on a program-based need. Involvement with in-licensing and acquisitions on individual due diligence activities.
Qualifications:
Successful candidates will meet the qualifications below with or without a reasonable accommodation.
Education Qualifications:
Master's Degree or equivalent preferred or PharmD or equivalent preferred or PhD or equivalent preferred or Postgraduate training in Therapeutic Area or related specialty, or equivalent preferred.
Experience Qualifications:
4 or More Years with PharmD, PhD, and relevant clinical experience preferred or 7 or More Years with Master's degree and relevant clinical experience preferred.
Travel:
Ability to travel up to 30%. In-house office position that may require travel (global).
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