Director, Clinical Scientist, Hematology Full-time

Director Clinical Sciences, Hematology

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

This role may be for you if:

• 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

To be considered for this position, you must have a bachelor's degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). Additionally, ≥ 10 years of pharmaceutical clinical drug development experience. We are specifically seeking experience with lymphoma/hematology oncology, and a 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. Other levels considered depending on experience. #Hematology

Salary Range (annually) $202,000.00 – $336,600.00