Senior Manager, Clinical Sciences, Hematology

Senior Manager, 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 Senior Manager 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 Senior Manager reports to either Associate Director or Director, Clinical Sciences and collaborates closely with Medical Director (MD) to provide scientific expertise necessary to design and deliver on clinical studies and programs.

As a Senior Manager, a typical day may include the following:

-  May function as lead Clinical Scientist for study 

-  Member of the Clinical Study Team and Global Clinical sub-team

-  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

-  Develops/maintains proficient 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

-  Utilizes basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets

-  Assists with development of the Expanded Synopsis and may author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments

-  Assists with and may authors/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support development of regulatory documents; may perform quality review

-  Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety

-  Contributes to preparations for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority). Presents data and information to external investigators (SIV) and internal stakeholders

-  Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety

-  Exhibits strong analytical knowledge and skills to understand how study objectives and design impact data analysis; supports identification and/or identifies critical risks and mitigations

-  Promotes consistent first line clinical data review techniques and conventions across studies; Reviews clinical data review plan and medical monitoring plan for assigned studies

-  May provide guidance to junior members of team 

This role may be for you if:

-  Possess demonstrated knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrate solid medical writing skills

-  Proven ability to influence within team and may influence across functionally

-  Exhibit strong analytical and influencing skills; ability to communicate concise and clear messages, strong presentation skills

-  Independently uses professional concepts and company objectives to resolve complex issues in creative and effective ways 

-  Strong management, interpersonal and problem-solving skills.

-  Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. 

-  Proven track in clinical trial process improvements.

-  Considerable organizational awareness, including significant experience working cross-functionally

To be considered for this position, you must have a minimum of Bachelor’s Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). We are seeking ≥ 8 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. You have a basic knowledge of oncology or hematology therapeutic areas as well as a proven track in clinical trial process improvements. We need an individual with demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs. Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Resolves novel problems requiring creative application of advanced skill, training, and education. 

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 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. #GDECDJobs #LI-Hybru