Associate Director, Clinical Scientist
1 month ago
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 16,000 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
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 setupStudy 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 updateExternal 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 / AROAdditional 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 activitiesQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Master's Degree or equivalent preferred orPharmD or equivalent preferred orPhD or equivalent preferredPostgraduate training in TA or related specialty, or equivalent preferredExperience Qualifications4 or More Years with PharmD, PhD and relevant clinical experience preferred7 or More Years with Master's degree and relevant clinical experience preferredTravelAbility to travel up to 30%. In-house office position that may require travel globally. 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.-
Associate Director, Clinical Safety Scientist
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, Clinical Pharmacology
2 weeks ago
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeWe are looking for an Associate Director, within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support t Clinical, Director, Associate, Oncology, Clinic, Healthcare
-
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, Clinical Scientist-1
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Early Asset Lead, Global Clinical Science
4 days ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Director, Biostatistics
2 weeks ago
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeLocation field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or City and state must be separated by a comma followed by a space (e.g., Houston, TX )Regeneron Pharmaceuticals Director, Biostatistics - Oncology in Basking Ridge , New Jersey The Director of Biostatistics provides leadership and guidance as the...
-
Associate Director, Clinical Data Standards
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingCompany is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director, Clinical Data Standards, is responsible for the development, maintenance, and enforcement of data standards through extensive collaborations with...
-
Assoc Dir Clin Safety Scientist
2 weeks ago
Basking Ridge, New Jersey, United States Hire Talent Full timeJob Title: Assoc Dir Clin Safety ScientistJob Schedule: Candidate must be local and able to go into office 1-2 days a week. Global Travel ~ 20% of Time *Please see attached for further responsibilities & job details. " This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to...
-
Director, Translational Biomarkers
6 days ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, Clinical Science
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, Clinical Science
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, Clinical Science
2 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob 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 world-class science and technology. With more than 100 years of scientific expertise...
-
Associate Director, Clinical Science
2 weeks ago
Basking Ridge, New Jersey, United States BioSpace Full timeJob DetailsJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, GMA Oncology
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, GMA Oncology
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, Regulatory Operations
3 days ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, GMA Oncology
2 weeks ago
Basking Ridge, New Jersey, United States BioSpace Full timeJob DetailsJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Manager, Clinical Scientist
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Manager, Clinical Scientist
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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...
-
Associate Director, Biostatistics
2 weeks ago
Basking Ridge, New Jersey, United States System One Full timeJob Title: Associate Director, Biostatistics Client - Global Pharmaceutical Company Location: Remote, US Based only - must reside in EST or CST time zones Type: Direct Hire - Full time salaried direct with the client Base Salary: $180k - $195K Must Haves: Oncology lead experience. PhD 5+ years Oncology clinical trial experience OR Master in Biostatistics -...