We are seeking a dedicated and experienced Japan Clinical Development Lead (J-CDL) to join our Clinical Sciences team. As a key member of the Global Clinical Sub Team (GCST), this role plays a crucial part in the planning and execution of clinical development programs in Japan. This position offers the opportunity to contribute significantly to our clinical programs and collaborate with cross-functional teams to ensure the success of our clinical trials.
Contribute to the clinical component of the Clinical Development Plan (CDP) in Japan.
Participate in the development and adaptation of clinical trial protocols, amendments, and recruitment/training materials.
Provide program-level clinical input for regulatory documents, including clinical sections of CTN submissions and J-NDA/J-CTD submissions.
Assess clinical feasibility with local medical needs for Japan's participation.
Offer medical/scientific input and advice by working closely with team members on assigned clinical studies.
Collaborate with regulatory affairs, project management, clinical operations, and other teams to support ongoing programs.
Ensure inspection readiness throughout the clinical program/study lifecycle.
You have a passion for clinical research and a deep understanding of the drug development process.
You are proficient in regulatory and compliance landscapes in the pharmaceutical industry.
You thrive in a collaborative environment and can effectively communicate with cross-functional teams.
You are committed to staying up to date on scientific and medical progress in development.
The ideal candidate will have an MD or MD/PhD or equivalent experience with at least 8 years of pharmaceutical industry experience, including a minimum of 5 years in clinical development. Experience with medical monitoring, protocol design, and regulatory filings is essential. Advanced clinical trial design expertise in Phase I, II, III, and the ability to integrate trials to meet objectives of the clinical development plan are required. Strong research background and analytical skills to support data review and medical writing skills are also necessary.
Join us in making a meaningful impact on clinical development programs in Japan. Apply today to be part of our dynamic and innovative team!
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.
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