- 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
- This CRS will focus mostly on pediatric regulatory documents and the execution of pediatric clinical trials.
- 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
-
Associate Director, Clinical Scientist-1
2 weeks ago
Daiichi Sankyo Inc. Basking Ridge, United States**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 ...
-
Associate Director, Clinical Scientist-1
4 weeks ago
Daiichi Sankyo Basking Ridge, United StatesJob 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 ou ...
-
Manager Clinical Safety Scientist
2 weeks ago
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. Summary · •This position supports proactive safety surveillance and risk man ...
-
Manager Clinical Safety Scientist
2 weeks ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. Summary · • This position supports proactive safety surveillance and risk manage ...
-
Manager Clinical Safety Scientist
1 week ago
Daiichi Sankyo Basking Ridge, United States Full timeJoin a Legacy of Innovation 110 Years and Counting · Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. · Summary · • This position supports proactive safety surveillance and risk management for a ...
-
Clinical Safety Scientist Lead
4 weeks ago
The Fountain Group LLC Basking Ridge, United Statescurrently seeking a Clinical Safety Scientist Lead for a prominent client of ours. This position is located in Basking Ridge, NJ. Details for the position are as follows: · Job Description:Hybrid Shift: Manager is looking for someone to come onsite 1-2 days a week. Glob ...
-
Regeneron Pharmaceuticals, Inc Bernards, United States Full timeThe Associate Director, Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads in a matrix environment as pa ...
-
Associate Director, Clinical Scientist
2 weeks ago
Daiichi Sankyo Inc. Basking Ridge, United States**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 ...
-
Associate Director, Clinical Scientist, Oncology
2 weeks ago
Regeneron Pharmaceuticals, Inc Bernards, United States Full timeWe are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of ...
-
Associate Director, Clinical Scientist
2 weeks ago
BioSpace Basking Ridge, United StatesJob Details · 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 wo ...
-
Associate Director, Clinical Scientist
2 weeks ago
Daiichi Sankyo Basking Ridge, United StatesJob 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 ou ...
-
BioSpace Basking Ridge, United StatesJob Details · The Associate Director, Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads in a matrix env ...
-
Manager, Clinical Scientist
2 weeks ago
Daiichi Sankyo Basking Ridge, United States Full timeJoin 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 scie ...
-
Clinical Scientist
3 weeks ago
Tris Pharma Monmouth Junction, United StatesApply · Description · Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including ap ...
-
Scientist, Clinical Evaluation
3 weeks ago
Coty Inc. Morris Plains, United StatesScientist, Clinical Evaluation · Morris Plains, NJ · Conduct product performance testing in color cosmetics and skin care using visual grading and instrumental methods. Provide support to recruit, schedule, and maintain local area panel database. Collaborate cross-functionally to ...
-
Materials Scientist 1
21 hours ago
Linkedin - Jobboard Franklin, United StatesPosition: Materials Scientist 1 · Location : Franklin Lakes, NJ · Duration : 12+ Months contract · Total Hours/week: 40.00 · 1st Shift · Client: Medical Device Company · Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) · No H1bs · Description · Job D ...
-
Associate Director, Clinical Scientist
14 hours ago
Daiichi Sankyo Basking Ridge, United States Full timeJoin 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 scie ...
-
Clinical Researcher Scientist
1 week ago
Bionic Sight New York, United StatesWHO WE ARE · We are a neuroscience lab at Cornell University that has generated two well-funded · start up companies in New York City – one that develops new kinds of prosthetic · devices, and one that develops new kinds of smart robots. The lab develops the ideas, · and the comp ...
-
Pre-clinical Scientist
2 weeks ago
Gan & Lee Pharmaceuticals Somerville, United StatesJob Description · Job DescriptionSummary · This position reports to the department head of non-clinical sciences. The Non-Clinical Scientist provides the overall leadership regarding the non-clinical scientific and strategy for an asset and is accountable for meeting all non-clin ...
-
Regeneron Pharmaceuticals Basking Ridge, United StatesThe Senior Manager, Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part of a ...
Associate Director, Clinical Scientist-1 - Basking Ridge, United States - BioSpace
Description
Job DetailsJoin 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.
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
Education Qualifications (from an accredited college or university)
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.
