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Manager, Clinical Scientist, Hematology

$128.6k - $210k

Initial Therapeutics, Inc.

Build our future together: At Regeneron, we use science and innovation to develop life‐changing medicines for people with serious diseases. We are seeking a Manager to join our Clinical Scientist, Hematology department. You will lead in the development, evaluation, planning and execution of clinical studies and ensure scientific integrity and interpretation of study data of a clinical development program. 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 Senior Manager, 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. When & where: Location: Tarrytown, NY, Warren, NJ Hybrid; 4 days per week on site Discover your role: 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, 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 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 This role requires: Bachelors Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc) A minimum of 3 years of pharmaceutical clinical drug development experience You have a basic knowledge of oncology or hematology therapeutic areas as well as a proven track in clinical trial process improvements Proven 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 Benefits: Health and wellness programs (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 Benefits vary by location Equal Opportunity Employer Statement 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. Salary Range (annually) $128,600.00 - $210,000.00 #J-18808-Ljbffr Initial Therapeutics, Inc.

Vacancy posted 1 day ago
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