About this role
About the Role Under supervision of Clinical Science Asset Lead or Clinical Science Lead within Hematology, 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. What You'll Do
- Drafts development plans under supervision and participates in study design to meet objectives, owning sections/components
- Provide strategic direction to Biostatistics and Data Operations for EDC, edit checks, data quality listings, SAP, Data Management plan and to Clinical Operations on SDV plan
- Develop biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology
- Co-lead Integrated Data Review Plan process with Data Management
- Contribute to study planning, milestones, risk assessment, protocol deviations, and contingency planning
- Lead protocol and ICF development; input on DSMB/adjudication committee setup; monitor protocol compliance
- Ensure recruitment/retention; manage contingency plans for shortfalls
- Review data quality; collaborate with BD&O on SAP updates; participate in dose-escalation meetings
- Collaborate with TMCP on biomarker/PK measurements; draft clinical sections of regulatory documents
- Engage with internal experts and external KOLs; align CRO/ARO statements of work; communicate across CRO/vendor/ARO
- Support due diligence activities related to in-licensing and acquisitions What We're Looking For
- Education: Bachelor's degree in life sciences or related field required; Master's/PhD/PharmD preferred; TA or related specialty preferred
- Experience: 4+ years with PharmD/PhD and relevant clinical experience preferred; 7+ years with Bachelor's or Master's and relevant experience preferred; Hematology experience preferred
- Technical: Advanced understanding of pre-clinical and clinical research, protocol writing, data review, study design, and disease area knowledge Nice to Have
- Hematology experience (preferred)
- Postgraduate training in TA or related specialty or equivalent (preferred) Compensation & Benefits
- Salary range: USD 162,400 - 243,600 per year
- Benefits: PDF with Benefits Summary available for download