- Study Strategy:
- Study Planning and Execution:
- Study outputs:
- External collaboration:
- Master's Degree or equivalent preferred or
- PharmD or equivalent preferred or
- PhD or equivalent preferred
- Postgraduate training in TA or related specialty, or equivalent preferred
- 4 or More Years with PharmD, PhD and relevant clinical experience preferred
- 7 or More Years with Master's degree and relevant clinical experience preferred
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Associate Director, Clinical Scientist-1 - Basking Ridge, United States - Daiichi Sankyo Inc.
Description
Join 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.
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.
SummaryOversees 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
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 updateAdditional 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
This CRS will focus mostly on pediatric regulatory documents and the execution of pediatric clinical trials.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
Ability to travel up to 30% In-house office position that may require travel (global).
_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.
_At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success.
We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration.
We provide employees with the training, tools and technology that they need to excel.Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized.
We invite you to consider a career at Daiichi Sankyo, Inc.