The Director, Clinical Sciences, Oncology 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/or late phase development. The Director reports to the Senior Director, Clinical Sciences, Oncology and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. Responsible to manage a team of clinical scientists.
As a Director in Clinical Sciences, a typical day may include the following:
- May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist.
- Guides assigned Program team(s)/direct reports and serves as a 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.
- 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.
- Maintains advanced 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 to propose, design, and implement clinical research and development studies for early and/or 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 clinical trial protocols, 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 resolves cross-functional comments independently.
- Independently leads planning and prepares information for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators.
- Performs and coaches direct reports in clinical/medical data review ensuring 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/program.
- May serve as a peer coach and/or mentor and provides guidance to junior members of department and cross-functional team members as appropriate.
This role may be for you if:
- Exhibits high level of skill in building teams and coaching 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.
To be considered for this role, you must have a Bachelor’s Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). We are seeking a minimum of ≥ 10 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. We are seeking advanced knowledge of the global drug development process, Good Clinical Practice, complex study design, clinical research methodology & medical writing skills. Uses professional concepts to evaluate novel problems and develop novel solutions for critical organization-wide issues and broad design matters. Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs. Strong direct-line and cross-functional management, interpersonal and problem-solving skills. Extensive knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines. Proven track in clinical trial process improvements. Organizational awareness, including significant experience working cross-functionally.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
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