- Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam
- Develops/maintains 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 review other scientific portions of clinical trial protocols and amendments
- Assists with and may author/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support the 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
- 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 medical/clinical data review techniques and conventions across assigned studies; Reviews clinical data review plan and medical monitoring plan for assigned studies
- Demonstrated ability to Influence within team and may influence across functionally
- Exhibits 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
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Regeneron Pharmaceuticals Tarrytown, United StatesThe Associate Director, Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads in a matrix environment as pa ...
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Regeneron Pharmaceuticals, Inc. Tarrytown, United States Full timeThe Associate Director, Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads in a matrix environment as pa ...
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Senior Manager, Clinical Scientist, Hematology - Tarrytown, United States - Regeneron Pharmaceuticals
Description
The Senior Manager, Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program.
The Sr.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 Sr.Manager reports to the 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.
As a Senior Manager in Hematology Clinical Sciences, a typical day may include the following:This role may be for you if:
To be considered for this role, you must have a Bachelor's Degree; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc).
We are seeking proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & medical writing 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. Other levels considered depending on experience. #HematologyDoes 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.
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)
$145, $237,200.00
