Sr. Manager Clinical Sciences, Hematology participates in the evaluation, strategic planning and execution of Hematology clinical development programs. Under the supervision of the Associate Director/Director, and in collaboration with operational supervisor (Medical Director), will participate in the development of key study documents and perform independent multi-factorial analysis of scientific and clinical data to help guide product development and execution.
A day in the life may include the following responsibilities:
- Assigned responsibilities include development of specific sections of protocol and related documents; can include development of study tools; guidelines and training materials; management of clinical study material; conduct clinical data review.
- Utilizes basic scientific expertise to support initiation and execution of research and development programs for early and/or late stage assets.
- Responsible for data review and contributor to medical monitoring plan for assigned studies. Promotes consistent data review across assigned studies.
- Conducts detailed analyses of clinical data. Must be resourceful and have outstanding abilities to synthesize and make connections.
- Helps author clinical documents such as Expanded Synopsis, Clinical Study Protocol, amendments and related documents, Informed Consent Form, Monitoring Plan, Investigator Brochure, and other key study and program documents.
- Trains and supports study staff and CRAs/CRO on study protocol and related questions and serves as point of contact for managing/answering questions relating to clinical aspects and subjects’ eligibility. Supports Associate Director/Director in development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis.
- Works independently and exercises judgment in resolving critical problems not always covered by existing standards, policies and procedures.
- Contributes to decision-making and provides well-reasoned, thorough reviews, due diligence and proposals to cross-functional project teams. Engages in productive team discussions and provides assistance to translational sciences support for assigned projects.
- Contributes to the development and optimization of Regeneron’s indication knowledge-base to facilitate information sharing across the organization.
- Manages interactions with relevant line functions such as Data Management, Clinical Operations, etc., under the direction of the Associate Director/Director. Attends Clinical Study Team (CST) meetings, participates and represents Clinical Sciences function, including reporting of any relevant functional study updates.
This job may be for you if you have the following:
- Bachelor’s Degree required .
- Fluent English (oral and written)
- ≥8 years of pharmaceutical clinical drug development experience. Experience in hematology desirable.
- Excellent prioritization, communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines with quality.
- Proven ability to work independently and collaborative in a team setting.
- Proven networking skills and ability to train junior colleagues.
- Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.