The Director Clinical Sciences 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, DMCs, Regulatory Authority)
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 seeking experience with rare disease. Experience with Patient Reported Outcomes data collection is desirable. We need 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
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)