Associate Director, Clinical Science

Job Summary

Under supervision of Clinical Science Asset Lead or Clinical Science Lead within Hematology, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Oversees a clinical trial. Prepares clinical section of regulatory document. Represents Clinical Science on Project Team and collaborates as team member with other functions, AROs/CROs. Provides scientific direction to Clinical Operations and other functions. This position requires minimal supervision to provide critical study-level support to the CSL/PS/MM/GCL for the successful execution of assigned studies.

Job Description

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

Experience Qualifications

• 4+ years with PharmD, PhD and relevant clinical experience preferred
• 7+ years with Bachelor's or Master’s degree and relevant clinical experience preferred
• Hematology experience is preferred
• 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 travel (global, up to 30%).