Manager, Clinical Scientist, Hematology

The Manager, Clinical Sciences, Hematology leads in the development, evaluation, planning, and execution of clinical studies, ensuring scientific integrity and interpretation of study data within a clinical development program. The Manager collaborates with Medical Director (MD) to design and deliver clinical studies and programs in a cross-functional, matrix environment.

As a Manager, a typical day may include:
- Member of the Clinical Study Team and Global Clinical sub-team
- Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent function in collaborations
- Maintain deep understanding of therapeutic disease area(s) and drug candidate (disease biology, clinical manifestations, standard practice, mechanism of action, drug landscape)
- Support initiation and execution of early and/or late-stage clinical research and development studies
- Assist with development of the Expanded Synopsis; author/review clinically relevant sections of protocols and amendments
- Assist with and may author/review trial documents (medical monitoring plans, SAPs, informed consents, Clinical Study Report clinical components); support regulatory documents; perform quality review
- Maintain compliance with FDA/EMEA/ICH/GCP guidelines and applicable SOPs
- Prepare for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); present data to investigators (SIV) and internal collaborators

This role may be for you if:
- Demonstrated knowledge of drug development process, GCP, study design, clinical research methodology; solid medical writing skills
- Proven ability to influence within and across functions; strong analytical, influencing, communication, and presentation skills
- Independently resolves complex issues using professional concepts and objectives

Qualifications:
- Bachelor’s degree required; advanced degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
- 3+ years of pharmaceutical clinical drug development experience (other levels considered)
- Basic knowledge of oncology or hematology therapeutic areas; proven track in clinical trial process improvements
- Demonstrated leadership and accomplishment in global clinical trials and clinical program execution
- Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines

Application instructions: Apply now.