Manager, Clinical Scientist, Hematology

Role Summary

The Manager, Clinical Sciences, Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Senior Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Manager reports to either Associate Director or Director, Clinical Sciences and collaborates closely with Medical Director (MD) to provide scientific expertise necessary to design and deliver on clinical studies and programs.

Responsibilities

• Member of the Clinical Study Team and Global Clinical sub-team
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments
• Develops/maintains 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
• Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets
• Assists with development of the Expanded Synopsis and may author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
• Assists 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
• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• Contributes to preparations for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority). Presents data and information to external investigators (SIV) and internal collaborators

Qualifications

• Required: Minimum of Bachelor’s Degree
• Preferred: Advanced degree or equivalent in life science/healthcare (PhD/MD/PharmD/MSc)
• Minimum of 3 years of pharmaceutical clinical drug development experience (other levels considered depending on experience)
• Basic knowledge of oncology or hematology therapeutic areas and proven track in clinical trial process improvements
• Demonstrated leadership and accomplishment in conducting global clinical trials and execution of clinical programs
• Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines
• Ability to resolve novel problems requiring creative application of advanced skill, training, and education

Skills

• Knowledge of drug development process, Good Clinical Practice, study design, clinical research methodology
• Strong medical writing skills
• Ability to influence within team and across functions
• Strong analytical and influencing skills; concise and clear communication; strong presentation skills

Education

• Bachelor’s Degree required; advanced degree (PhD/MD/PharmD/MSc) preferred