Associate Director Oncology R&D

Daiichi Sankyo Inc.   •  

Basking Ridge, NJ

Industry: Pharmaceuticals & Biotech

  •  

Not Specified years

Posted 58 days ago

This job is no longer available.

Job Summary

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.

Responsibilities

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

Qualifications

Education

  • MSc or MPH; PharmD, PhD, MD or equivalent desirable; Postgraduate training in TA or related specialty, or equivalent, desirable

Experience

  • MSC or MPH - 3 Years
  • PharmD, or PhD – None
  • MD or MD/PhD - None

Competencies

  • Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Therapeutic Expertise, Drug Development, Critical Thinking, Team Leadership