Manager, Clinical Scientist, Hematology

About the role

Join our Clinical Scientist, Hematology department as a Manager to lead in the development, evaluation, planning and execution of clinical studies. Ensure scientific integrity and interpretation of study data of a clinical development program. Collaborate with cross-functional teams and contribute to candidate development projects.

Responsibilities

• Contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
• Represent function in collaborative activities with other departments
• Develop/maintain proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
• Support initiation and execution of clinical research and development studies for early and/or late-stage assets
• Assist with development of the Expanded Synopsis and may author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
• Assist with and may authors/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support development of regulatory documents; may perform quality review
• Maintain compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• Prepare for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority)
• Present data and information to external investigators (SIV) and internal collaborators

Requirements

• Bachelor’s Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
• A minimum of 3 years of pharmaceutical clinical drug development experience
• Basic knowledge of oncology or hematology therapeutic areas as well as a proven track in clinical trial process improvements
• Proven leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs
• Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines
• Resolve novel problems requiring creative application of advanced skill, training, and education

Qualifications

• Proven ability to influence within team and may influence across functionally
• Strong analytical and influencing skills; ability to communicate concise and clear messages, strong presentation skills