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Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.
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
- MSc or MPH; PharmD, PhD, MD or equivalent desirable; Postgraduate training in TA or related specialty, or equivalent, desirable
- MSC or MPH - 3 Years
- PharmD, or PhD - None
- MD or MD/PhD - None
- Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Therapeutic Expertise, Drug Development, Critical Thinking, Team Leadership
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.