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We are seeking an Associate Director- Clinical Trial Management to join our Oncology team as a part of our new Regeneron Cell Medicines (RCM) group. You will independently lead our clinical study, including planning, maintaining timelines and budgets, vendor management, relationship management between clinical sites and vendors, management of clinical sites, liaise with internal and external collaborators, and identification of project risks and contingency planning.

As an Associate Director- Clinical Trial Management, a typical day might include:

• Leading day to day operations of clinical early phase oncology cell therapy studies, overseeing clinical study team management, and maintaining accuracy of information in trial databases and tracking systems

• Overseeing external CROs/vendors, study managers, field clinical monitors, and investigative site staff to ensure trial(s) are managed to the highest quality

• Forecasting trial resource needs (external costs), being accountable for the trial level clinical operations budget, management, as well as leading development of SOWs, site budgets, CTAs, etc.

• Communicating study status, issues, risks, and mitigations to relevant cross-functional teams and leading trial level interactions with relevant external functions and internal functions

• Collaborating closely with internal groups to ensure robust plans for trial level data review including trend evaluation

• Developing and reviewing critical study documents including informed consent forms, study conduct documents, as well as participating in the development and amendments of protocols, investigator brochures, informed consents, etc.

• Performing research site activities, such as site qualification visits, site initiation visits, trainings, and motivational visits

• Providing oversight, training, and support for field clinical monitors

This role might be for you if you:

• Can work independently and lead a clinical operations team, managing interactions with and between internal and external team members

• Have strong attention to detail and excellent verbal and written communication skills

• Are able to flexible and shift with changing priorities

In order to be considered for this role, you must have at least a BS/BA in science or a health-related field and 10+ years of relevant clinical study management experience. Biotech/pharmaceutical industry or contract research organization experience preferred. We need someone with operational and managerial experience in planning, driving, reporting, and publishing clinical studies in trial and site startup. Experience with Phases 1-4 Oncology trial management required. Knowledge of RECIST strongly preferred. Oncology monitoring experience preferred. Must have excellent knowledge of GCP, ICH, and FDA regulations. FIH, early development, and pivotal experience preferred. Cellular therapy experience a plus. Must be able to travel up to 25%, including internationally.

Regeneron Cell Medicines (RCM) has been created to advance the next generation of cell therapies and explore combinations with Regeneron’s proprietary antibodies and bispecifics. We are a group of about 160 research, development, manufacturing and clinical employees based in Seattle, WA and Cambridge, MA.

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)

$151,800.00 - $247,800.00