BioSpace
Website:
biospace.com
Job details:
Build Our Future Together
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clinical Sciences to join our Global Capability Center (GCC) in Hyderabad. In this role, you will lead and manage a centralized pool of Clinical Data Reviewers (CDRs) and Medical Narrative Reviewers (MNRs), ensuring high-quality clinical review support across the development portfolio. You will oversee onboarding, training, performance management, resource allocation, capacity planning, and operational excellence while partnering closely with Clinical Scientists, Medical Directors, and cross-functional stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & Where
Hyderabad (Hybrid)
Discover Your Role
- Lead the day-to-day functional management of a centralized pool of Clinical Data Reviewers and Medical Narrative Reviewers, serving as the primary point of contact for resource coordination across studies and programs.
- Translate portfolio-level study assignments into resource prioritization plans and monitor delivery against achievements and key operational objectives.
- Personally perform clinical data review, query management, and medical narrative review activities when required to support coverage gaps, onboarding periods, workload surges, or quality remediation initiatives.
- Establish, monitor, and report key performance indicators (KPIs), ensuring compliance with SOPs, Restricted Data Handling requirements, and quality standards.
- Lead onboarding and training activities, including SOP assignment, systems access support, and reviewer readiness assessments in partnership with Clinical Scientists and Study Medical Directors.
- Drive capacity forecasting and workforce planning activities by collaborating with Clinical Scientist Leads and Clinical Program Leads to align resources with study timelines and business needs.
- Ensure continuity of governance and operational excellence during team transitions, turnover, protocol changes, and study closeouts.
- Support knowledge management, institutional learning, and consistency of reviewer practices across the portfolio.
- Represent the Clinical Sciences function within the GCC and contribute to strategic initiatives focused on quality, efficiency, and process improvement.
This Role Requires
- Advanced degree in a scientific or medical field; MD, PhD, PharmD, or equivalent strongly preferred.
- Minimum 7 years of experience in clinical research, drug development, pharmaceutical operations, or related healthcare industry environments.
- Hands-on experience performing clinical data review and/or medical review of patient narratives.
- Practitioner-level knowledge of EDC systems, clinical data review tools, query management processes, and narrative review activities.
- Demonstrated experience managing, coaching, and developing clinical and medical professionals within a matrixed and cross-functional environment.
- Strong operational leadership, quality governance, and stakeholder management capabilities.
- Excellent communication, collaboration, and interpersonal skills with the ability to influence and lead distributed teams.
- Strong analytical, critical thinking, and problem-solving abilities.
- Scientific and medical competence to understand, evaluate, and communicate complex clinical development concepts.
- Willingness to perform hands-on review activities as needed to ensure quality, continuity, and timely delivery.
- High level of integrity, professionalism, and discretion when handling sensitive information.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Click on Apply to know more.