1 of 2 Positions: As a Senior Manager in Clinical Sciences, Oncology, you will assist in the development, evaluation, planning, and execution of clinical studies. Additionally, you will ensure scientific integrity and interpretation of study data of a clinical development program. You will work in a highly collaborative, matrixed environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. You will report to the Senior Director, Clinical Sciences and collaborate closely with Medical Director(s) (MDs) to provide scientific expertise vital to design and deliver on clinical studies and programs.
As a Senior Manager in Oncology Clinical Sciences, a typical day may include the following:
- Contributing to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; participating in collaborative activities with other departments; being a member of the Clinical Study Team and the Global Clinical Sub-Team.
- Developing and maintaining an 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 limited knowledge of disease and drug landscape.
- Utilizing basic scientific expertise to support execution of clinical research and development studies for early and/or late stage assets.
- Assisting with preparation of documents related to trials, such as medical monitoring plans, SAPs, informed consents, clinical components of the Clinical Study Reports, and regulatory documents; collaborating with others for scientific and foundational guidance.
- Maintaining compliance in accordance with FDA, EMEA, ICH, and GCP guidelines as well as applicable SOPs regarding clinical safety.
- Contributing to preparations for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority).
- Supporting clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety; supporting identification of data trends and potential inconsistencies in data across assigned studies and raising appropriately.
- Exhibiting basic research and analytical knowledge to understand how study objectives and design impact data analysis; supporting identification of critical risks and mitigations to study.
This role may be for you if:
- You have demonstrated the ability to influence and share new insights with the study team.
- You independently resolve most issues and complex matters, requiring sophisticated analytical skill, training, and/or education. You raise highly complex problems or out-of-policy issues.
- You possess strong management, interpersonal, and problem-solving skills.
To be considered for this role, you must have a Bachelor’s Degree required; an advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). We are seeking candidates with ≥ 8 years of pharmaceutical clinical drug development experience. Proven knowledge of the drug development process, Good Clinical Practice, study design, and clinical research methodology; beginner level medical writing skills are also required. We are seeking knowledge of the clinical development process, regulatory requirements, and ICH/GCP guidelines. Proven track record in clinical trial process improvements is essential. Considerable organizational awareness, including significant experience working cross-functionally, is also required.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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 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.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications, etc.
Salary Range: (annually) $145,400.00 - $237,200.00
#J-18808-Ljbffr
