Job Summary

Under supervision of Clinical Science Asset Lead or Clinical Science Lead, 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.

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.