Associate Director, Clinical Science

Job Summary

Responsibilities

Study Strategy:

• Under supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans.


• Participates in the development of study design to meet study objectives by owning sections/components.


• Provides strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan.


• Develops biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP).


• With Data Management, co-leads or provides input to the Integrated Data Review Plan process.

Study Planning and Execution:

• Provides input on major milestones of trial, clinical trial plan and contingency planning. Analyzes and updates management on potential risks to study deliverables.


• Leads study team in authoring of protocol and responsible for ICF creation or provides input on ICF creation.


• Consults and recruits members for DSMB and/or adjudication committee setup and develops supporting documents and charters.


• Leads development of protocol deviation management plan and contributes to monitoring protocol compliance to ensure proper identification and categorization of protocol deviations.


• Reviews inclusion/exclusion criteria and other study design elements for consistency with study strategy.


• Oversees recruitment and retention; establishes and implements contingency plans for shortfalls.

Study outputs:

• Reviews emerging clinical data regularly and shares data review findings with the study team.


• Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data; works with BD&O to ensure SAP update.


• Leads dose-escalation meetings and other site facing interactions with Clinical Operations.


• Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements.


• Draft clinical sections of regulatory documents and responses to IRBs and Health Authorities.

External collaboration:

• Consults with internal experts and external KOLs, Ad Boards for protocol development.


• Provides input on CRO / ARO Statement of Work and Budget; represents Clinical Science in study team meetings with CRO and ARO


• Establishes effective communication between CRO / vendors / ARO. Additional non-study related activities: Occasional senior management interactions at FIHC, WDC.


• Initiates contact w/KOL and prepares material for KOL interactions to support study-based needs.


• Supports due diligence activities related to in-licensing and acquisitions.

Qualifications

Education Qualifications

• Bachelor's Degree life sciences or related field required


• Master's Degree, PharmD, PhD or equivalent preferred


• Postgraduate training in TA or related specialty, or equivalent, preferred

Experience Qualifications

• 4+ years with PharmD, PhD and relevant clinical experience or 7+ years with Bachelor's or Master’s degree and relevant clinical experience required


• Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred

Travel Requirements
In-house office position that may require global travel.