Senior Director, Clinical Development - Oncology in Bernards, NJ at DSI

Date Posted: 2/18/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

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.

Job Summary

Oversees a number of trials of a multinational program in a specific indication, i.e., multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)

Responsibilities

For Phase 2 and Phase 3 registrational studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration with TMCP, Collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project; Attends EOP2 meeting and represents clinical/TMCP

Clinical Study Lead (CSL) for large Phase 3 registrational studies; Develop prospective contingency plans for management of key risks in a large study or project; Clearly define study priorities and high level execution plan, communicate to members of study team within sponsor, CRO and vendors; Ensure clear and effective lines of communication and decision-making process cross-functionally and cross-regionally; Facilitate team coordination

For Phase 3 studies: Drafts responses to IRBs and HA, Collaborates with TMCP 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 TLG before DBL, and quality check of data, Works with BD&O to ensure SAP updates; Interact with Key Opinion Leaders (KOLs) to validate interpretation of study results; Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies in the project and other drugs used for the indication
(MD only) For large Phase 3 studies: Reviews, edits, approves and updates medical monitoring plan, Develops SAE flow plan for AESI in conjunction w/ CSPV, 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; Coordinate sponsor medical monitors across regions; Direct CRO medical monitor activities for a large study and/or across a program

(MD only) For studies within a project: Collaborates with CSPV 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, assist BDO in creation of TFG, Reviews, oversees creation of patient narratives, Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations, e.g. language for IB; Documents ongoing MM review of data for safety (with CSPV) and quality at project level

Develops and leads Ad-Board with top tier KOLs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KOLS for advice on complex development or safety issues

Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for program/s under IST; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and clinical development strategy; Leads Integrated Project Team (IPT) working closely with Global Project Management to ensure cross-functional coordination and focus to agreed strategy; Coordinates clinical activities across the project; Represents IPT to Sr. Management

Leads large study or project teams involving multiple functions and many members with or without a direct reporting relationship

Provides input on KOL selection for Therapeutic Area; Reviews content to be shared with KOLs; Frequent involvement in Business Development activities for late stage compounds; Involvement with in-licensing and acquisitions on due diligence activities; Major contributor to portfolio decisions

Qualifications:

Education:
PharmD, PhD, MD or equivalent; Postgraduate training in TA or related specialty

Experience:
5 Years

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.