Associate Director, Clinical Science

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 162,000 - 244,000; Full time

Job summary

Daiichi Sankyo US seeks a Clinical Science professional to draft development plans, protocols, informed consent forms, and regulatory sections. The role oversees a clinical trial and provides scientific direction to Clinical Operations and related functions, collaborating with CROs and AROs for successful study execution.

You will contribute to study strategy, planning, and data review while supporting due diligence activities and cross-functional teamwork.

Qualifications

• Bachelor's Degree life sciences or related field required
• Master's Degree, PharmD, or PhD or equivalent preferred
• Postgraduate training in TA or related specialty, or equivalent, preferred

Responsibilities

• Draft development plans under supervision of Clinical Science Asset Lead or Clinical Science Lead
• Develop study design to meet objectives and own sections/components
• Provide strategic direction to Biostatistics and Data Operations for EDC, SAP, and data quality listings
• Develop biomarker/PK strategy with Translational Medicine and Clinical Pharmacology
• Lead or input Integrated Data Review Plan with Data Management
• Provide input on major milestones and contingency planning for trials
• Lead protocol authorship and ICF creation; recruit DSMB/Adjudication committee
• Lead development of protocol deviation management plan and ensure protocol compliance
• Review inclusion/exclusion criteria for consistency with study strategy
• Oversee recruitment and retention with contingency plans
• Review emerging clinical data and share findings with study team
• Coordinate quality checks with BD&O and ensure SAP updates
• Lead dose-escalation meetings and site-facing interactions with Clinical Operations
• Collaborate to ensure biomarker, PK/PD measurements
• Draft clinical sections of regulatory documents and responses to authorities

Education

Bachelor's Degree life sciences or related field

Master's Degree, PharmD, or PhD or equivalent preferred

Postgraduate training in TA or related specialty, or equivalent, preferred

Job description

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

Under supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Oversees a clinical trial. Prepares clinical section of regulatory document. Represents Clinical Science on Project Team and collaborates as team member with other functions, AROs/CROs. Provides scientific direction to Clinical Operations and other functions. This position requires minimal supervision to provide critical study-level support to the CSL/PS/MM/GCL for the successful execution of assigned studies.

Responsibilities

Job Description

Study Strategy

• Under supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans.
• Participates in the development of study design to meet study objectives by owning sections/components.
• Provides strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan.
• Develops biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP).
• With Data Management, co-leads or provides input to the Integrated Data Review Plan process.

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.
• Leads study team in authoring of protocol and responsible for ICF creation or provides input on ICF creation.
• Consults and recruits members for DSMB and/or adjudication committee setup and develops supporting documents and charters.
• Leads development of protocol deviation management plan and contributes to monitoring protocol compliance to ensure proper identification and categorization of protocol deviations.
• Reviews inclusion/exclusion criteria and other study design elements for consistency with study strategy.
• Oversees recruitment and retention; establishes and implements contingency plans for shortfalls.

Study Outputs

• Reviews emerging clinical data regularly and shares data review findings with the study team.
• 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.
• Leads dose-escalation meetings and other site facing interactions with Clinical Operations.
• Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements.
• Draft clinical sections of regulatory documents and responses to IRBs and Health Authorities.

External Collaboration

• Consults with internal experts and external KOLs, Ad Boards for protocol development.
• Provides input on CRO / ARO Statement of Work and Budget; represents Clinical Science in study team meetings with CRO and ARO
• 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 to support study-based needs.
• Supports due diligence activities related to in-licensing and acquisitions.

Qualifications

Education Qualifications

• Bachelor's Degree life sciences or related field required
• Master's Degree, PharmD, or PhD or equivalent preferred
• Postgraduate training in TA or related specialty, or equivalent, preferred

Experience Qualifications

• 4+ years with PharmD, PhD and relevant clinical experience or 7+ years with Master’s degree and relevant clinical experience preferred
• Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge. preferred

Travel Requirements

Ability to travel up to 20% of the time. 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.

Salary Range

USD$162,400.00 - USD$243,600.00