Basking Ridge, NJ
Industry: Pharmaceuticals & Biotech•
Not Specified years
Posted 58 days ago
Oversees a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.
Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.
1. Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)
2. 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; Provides input on ICF creation; Oversees recruitment and retention; establishes and implements contingency plans for shortfalls; Consults & recruits members for DSMB and/or adjudication committee setup
3. Study outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; 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
4. Medical monitoring planning (MD only): Reviews, edits, approves and updates medical monitoring plan; Develops SAE flow plan for AESI in conjunction w/Clinical Safety and Pharmacovigilance; Defines medical monitoring oversight component of study QOP; Sets up DSMB and/or adjudication committee; Reviews and edits DSMB/ Adjudication charters; Develops medical content for protocol profile, protocol and amendments for small, uncomplicated clinical studies
5. Medical surveillance (MD Only): Collaborates with Clinical Safety and Pharmacovigilance to ensure monitoring/reporting of AEs/SAEs; Reviews safety reports/data during study conduct; Provides and documents oversight of medical monitoring activities; Reviews data before DBL from medical perspective, assists Biostatistics and Data Operations in creation of TFG; Reviews and oversees creation of patient narratives; Provides medical direction to Medical Writing for the CSR
6. External collaboration: Consults with internal experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between CRO / vendors / ARO
7. Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due diligence activities