Manager, Clinical Scientist, Hematology

Manager, Clinical Sciences, Hematology

The 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 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. A typical day may include the following :

• 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
• Applies 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 collaborators

This role may be for you if :

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 ? a minimum of 3 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 step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit careers.regeneron.com . For other countries' specific benefits, please speak to your recruiter.

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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and / or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.