Regeneron is seeking a Senior Director, Data Management Portfolio Delivery for our Oncology/Hematology therapeutic areas.
In this role, a typical day might include:- The Senior Director, Data Management Portfolio Delivery is a member of the Data Management Senior Leadership Team (DMSLT) and contributes to the vision, direction and strategy of the line function in support of the advancement of Regeneron's clinical pipeline globally. The incumbent will be responsible for leading, managing and developing a team of highly engaged data managers and portfolio leads. Additionally, this role is accountable for effective oversight and timely delivery of all clinical data management activities from study start-up through archival across multiple studies in one or more therapeutic area(s) ensuring fit-for-purpose clinical data and compliance with Regeneron procedures and applicable regulatory requirements.
- This position requires advanced knowledge of Electronic Data Capture systems, related applications, industry standards and regulatory requirements as well as progressive experience working on Phase I-IV studies and participating in regulatory submissions and health authority inspections within the medical device and/or pharmaceutical industry.
- The Senior Director, Data Management Portfolio Delivery will collaborate closely with the Clinical Data Management Central Services, Clinical Data Operations and External Data Acquisition and Delivery Teams along with internal stakeholders and external vendors at different levels to ensure continuous improvement and successful outcomes for studies/programs.
This role might be for you if you can/have: - Contribute to the overall vision, direction and strategy for Data Management line function and assigned therapeutic area(s).
- Accountable for operational execution and delivery of quality, fit-for-purpose data in support of statistical analyses across studies within assigned therapeutic area(s); provide comprehensive and effective oversight of FSPs and external partners.
- Perform evaluation of resource demand and allocation across studies/programs to ensure adequate staffing and high levels of productivity in support of departmental objectives and corporate level portfolio delivery goals; select and recruit top industry talent and provide constructive performance appraisals to ensure professional growth and development.
- Monitor group's performance with respect to quality, adherence to standards, compliance with the established SOPs, WIs and applicable regulations; ensure continuous inspection readiness.
- Proactively identify issues and propose solutions to mitigate operational risks and/or escalations for the function; provide strong leadership support for critical study data management milestones.
- Lead strategic cross-functional initiatives to promote increased process efficiency and operational excellence; drive optimization of technology, systems and processes focusing on decreased cycle times, improved quality and inspection readiness.
- Liaise with internal and external stakeholders to foster strong relationships and ensure effective cross-functional collaboration and communication throughout drug development process.
- Author and contribute to the development of global clinical data management SOPs/WIs and corresponding departmental training curricula.
- Demonstrate company values and act as a role model by promoting competence, collaboration, innovation, respect, ownership and accountability.
- Maintain awareness of Clinical Data Management emerging trends, technology solutions and industry best practices through peer relationships with thought leaders in the industry; represent Regeneron in professional associations and forums.
To be considered for this opportunity, you must have the following:- Bachelor's Degree required, Advanced degree desirable.
- 15+ years of clinical data management experience in a pharmaceutical or biotech setting.
- 10+ years of functional leadership
- 8+ years of people management, leadership and mentoring experience
- Leadership experience in Clinical Data Management or related field, leading midsized global data management groups across various therapeutic areas.
- Expertise in clinical data management processes, industry best practices and clinical data systems (EDC, eSource, eCOA, IRT, Clinical Data Repository, medical terminology coding solutions, laboratory normal range repositories).
- Advanced knowledge of clinical data management principles, technologies, regulations and best practices, including 21 CFR Part 11, ICH-Google Cloud Platform Guidelines, GxP compliance and GDPR, related to data acquisition, processing, handling and reporting used in drug development.
- Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry.
- Demonstrated success in solving complex business problems, strategic thinking, organizational design, leading through periods of significant change, i.e., operating model shifts, dynamic portfolio expansion, company and/or asset acquisitions.
- Ability to build relationships with key internal and external stakeholders at leadership levels and across levels by negotiating effectively, managing conflicts, escalations and collaborating successfully.
- Proven ability to establish highly motivated and performing teams with a focus on transformation, innovation and operational excellence.
- Excellent interpersonal, oral, and written communication skills.
- Ability to adjust in a fast-paced environment.
- May require up to 25% travel.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
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)$216,100.00 - $360,200.00
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