Senior Manager, Clinical Scientist, Hematology

Hiring By - Biostaffic

 BioPharma

Tarrytown, New York - United States

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
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:
  • 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
This Role May Be For You If
  • 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
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). Additionally, ≥ 8 years of pharmaceutical clinical drug development experience. 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. #Hematology
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 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. 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.
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)
$145,400.00 - $237,200.00

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Tarrytown, New York - United States

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Regeneron
Regeneron

Current Openings: 0

At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
Are you an employee? 🌟
Explore Biotech Jobs

Find the one that suits your cosmic aspirations. Search open positions across the web, find opportunities uniquely matched to your skills, and read reviews on companies worldwide. 🚀💼🌎

Are you an employer? 🌟

Hire Top Talent in the Biotechnology Industry.

Post jobs, search for stellar candidates, and conduct the complete hiring process—all from your desktop or mobile phone. 🚀🔬👩‍🚀