Clinical Science Director, Trials & Strategy

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

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.