Associate Director, Global Oncology R&D
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: April 8, 2021
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Job Description:
Associate Director, Global Oncology R&D in Basking Ridge, NJ
at DSI Job DescriptionJoin a Legacy of Innovation 110 Years and
Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical therapies to improve standards of care
and address diversified, unmet medical needs of people globally by
leveraging our world-class science and technology. With more than
100 years of scientific expertise and a presence in more than 20
countries, Daiichi Sankyo and its 15,000 employees around the world
draw upon a rich legacy of innovation and a robust pipeline of
promising new medicines to help people. In addition to a strong
portfolio of medicines for cardiovascular diseases, under the
Group's 2025 Vision to become a "Global Pharma Innovator with
Competitive Advantage in Oncology," Daiichi Sankyo is primarily
focused on providing novel therapies in oncology, as well as other
research areas centered around rare diseases and immune
disorders.
Job Summary:
Oversees typically 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:
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)
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
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
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
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: Successful candidates will be able to meet the
qualifications below with or without a reasonable
accommodation.
Education/Experience:
Master's degree; PharmD, PhD, or equivalent; Postgraduate training
in TA or related specialty, or equivalent, desirable
4+ years with PharmD, PhD and relevant clinical experience
7+ years with Master's degree and relevant clinical experience
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. 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.
Candidates with Disabilities Who Require Assistance Daiichi Sankyo,
Inc. provides reasonable accommodation in job application
procedures for qualified individuals with disabilities and disabled
veterans. If you have a disability that inhibits your ability to
apply for a position through our online application process or you
otherwise need accommodation in connection with the recruiting
process due to a disability, you may use the alternative methods
described below to contact us about your interest in Daiichi
Sankyo, Inc. and/or to request an accommodation. Daiichi Sankyo,
Inc.
211 Mt. Airy Road Basking Ridge, NJ 07920-2311
Attn: Staffing Dept. By Phone: Phone: 908-992-6400 Equal
Opportunity Employment Daiichi Sankyo, Inc. is an equal opportunity
/ affirmative action employer. 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.
Keywords: Daiichi Sankyo, Newark , Associate Director, Global Oncology R&D, Executive , Basking Ridge, New Jersey
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