Director, Clinical Scientist, Hematology

Regeneron Pharmaceuticals•Tarrytown, NY

61d

About The Position

The Director 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 Director leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and late phase development. The Director reports to the Senior 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. The director will be responsible for managing a team of clinical scientists. As a Director in Hematology, a typical day may include the following: May function as lead Clinical Scientist (CS) for program, and/or as delegate of Therapeutic area (TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam Line Manager for CS team and serves as key functional advisor or representative for the CS group; ensures alignment of process and procedures for CS across assigned assets/programs in alignment with TA expectation; Guides assigned Program teams/direct reports 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 Applies advanced scientific expertise to propose, design, and execute clinical research and development studies for early and late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently; Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, IDMCs, Regulatory Authorities) Performs and mentors direct reports in clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety Applies advanced analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies; Identifies areas of potential inconsistent data review Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of clinical data review plan and medical monitoring plans; ensures execution where appropriate for assigned studies/programs

Requirements

Exhibits high level of skill in building team and mentoring direct reports
Ability to lead activities within a matrix environment
Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally
Demonstrated ability to influence within team and department and may influence across functionally
Demonstrates exceptional initiative, creativity and innovation skills
Directly contributes to the development of innovations
Identifies opportunities to initiate operational changes
Strong direct-line and cross-functional management, interpersonal and problem-solving skills
Bachelor's degree required
Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
≥ 10 years of pharmaceutical clinical drug development experience
Experience with lymphoma/hematology oncology
Minimum of 4 years of direct and/or indirect management experience
Proven understanding of therapeutic disease areas and drug candidates including underlying disease biology, clinical manifestations and therapeutic standard practice, compounds including mechanism of action and drug landscape

Responsibilities

May function as lead Clinical Scientist (CS) for program, and/or as delegate of Therapeutic area (TA) Lead Clinical Scientist
Member of the Clinical Study Team and Global Clinical SubTeam
Line Manager for CS team and serves as key functional advisor or representative for the CS group
Ensures alignment of process and procedures for CS across assigned assets/programs in alignment with TA expectation
Guides assigned Program teams/direct reports
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
Applies advanced scientific expertise to propose, design, and execute clinical research and development studies for early and late stage assets
Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and independently supports the development of regulatory documents
Performs quality review and/or approval
Adjudicates and resolve cross functional comments independently
Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, IDMCs, Regulatory Authorities)
Performs and mentors direct reports in clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
Applies advanced analytical knowledge and skills to understand how program objectives and design impact data analysis
Identifies risks and designs mitigation strategies
Identifies areas of potential inconsistent data review
Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs
Leads drafting/updating/review of clinical data review plan and medical monitoring plans
Ensures execution where appropriate for assigned studies/programs