Senior Manager, Clinical Scientist, Hematology

Role Summary

The Senior Manager, Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. 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 Sr. Manager reports to the Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs.

Responsibilities

• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam
• Develops/maintains 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 review other scientific portions of clinical trial protocols and amendments
• Assists with and may author/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support the 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
• Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
• Exhibits strong analytical knowledge and skills to understand how study objectives and design impact data analysis; supports identification and/or identifies critical risks and mitigations
• Promotes consistent first line medical/clinical data review techniques and conventions across assigned studies; Reviews clinical data review plan and medical monitoring plan for assigned studies

Qualifications

• Required: Bachelor‚Äôs Degree; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). ‚â• 8 years of pharmaceutical clinical drug development experience. Knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & medical writing skills. Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical trial process improvements. Significant cross-functional collaboration experience.
• Preferred: Advanced degree (PhD/MD/PharmD/MSc) and extensive experience in hematology/clinical sciences; strong cross-functional leadership and matrix management capabilities

Skills

• Strong analytical and influencing skills; ability to communicate concise and clear messages, strong presentation skills
• Ability to resolve complex issues creatively and effectively
• Excellent management, interpersonal and problem-solving skills

Education

• Bachelor‚Äôs Degree required; Advanced degree or equivalent in life sciences/healthcare preferred

Additional Requirements

• Regulatory knowledge and experience with FDA/EMEA/ICh/GCP guidelines