117 jobs found in Stamford, CT

The Executive Director, Biostatistics (CDU-Biostatistics Head, Internal Medicine) leads the statistical team for the assigned Clinical Development Unit, in partnership with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs, Development Operations and Development Program Management, R&pD, and other key functions at Regeneron.  The incumbent is an experienced leader, passionate drug developer, skilled manager and mentor, and an accomplished statistician with a strong ability to communicate technical concepts to non-statisticians.   The Executive Director is responsible for providing critical strategic input to the development programs within the CDU, from pre-IPA through regulatory approval and post-marketing, and builds and empowers teams to ensure the successful execution on our pipeline.  The Executive Director drives the development of appropriate phase-specific statistical strategies are developed and implemented, such as...

As the Head of Publications (Executive Director) you will lead a team of publication managers and writers. We strive to ensure the quality and timely execution of publication projects while driving innovative approaches enabling broad scientific share of voice.  We will deliver strategic development and targeted delivery of clinical and HEOR global publications across all therapeutic areas. This will be across the life span of our assets in a heavily matrixed and scientifically interdependent environment. We have the need to drive a vision for the future that will involve creating efficiencies, showing tangible impact and measurement beyond traditional metrics and transcend beyond typical channels of communication. This position is located in Sleepy Hollow, NY and will require you to be on-site for a minimum of 3 days/week. We do not have a fully remote option for this position. If eligible, we can offer relocation benefits. A typical day may include the following:...

We are looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control, including but not limited to: release and in-process testing, stability testing, lab investigations, manufacturing failure investigations, environmental monitoring and microbiological testing. Providing comprehensive testing support to clinical and commercial manufacturing, regulatory inspections, filing and facility operations. Leading operational and technological collaboration between the QC group and its business partners. In this role, a typical day might include the following: Leading a full scale of QC operation to support production, facility and cGMP compliance. Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. Interpreting scientific data and draw reasonable conclusions. Advising manufacturing, QA, RA, facilities and material management of quality control requirements and...

We are currently looking to fill a Sr/ Executive Director, GMP Data Governance & Integrity position. This position is responsible for the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program. Directs and leads the activities of team. Works closely with business leaders and department subject matter experts to implement data integrity standards into business operations. Serves as the global leader on good practices for their area. Develops and delivers effective training and education programs; works with the business to embed practical steps into procedures, processes and other documentation. In this role, a typical day might include the following: Business Priorities: Global owner and lead for Data Governance and Integrity – defines the standard and ensures broad understanding and integration across the business Partners with personnel to define or revise associated business processes to meet defined standards; applies...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

We are seeking a Director to join our Precision Medicine team. The Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely with Senior Director, Precision Medicine CDx and key cross-functional collaborators to deliver innovative diagnostics solutions in support of Regeneron programs. The primary role will be to guide strategy for patient selection/stratification passionate about immunohistochemistry (IHC) and lead implementation and execution of CDx assays (from study conduct, sample management testing to launch) in collaboration with partners/IVD Sponsors and central testing laboratories to support early and late-stage programs within our oncology pipeline. As a Director, a typical day may include the following: Define innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs Develop strong relationships partnerships with IVD partners and testing...

This role is a hybrid position which requires a minimum 3 days on-site in Basking Ridge, NJ or Armonk, NY. Remote work is not an option for this role. The Program Operations Leader (POL) will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and...

This role is a hybrid role on-site 3 days per week and 2 days from home. A fully remote role is not possible. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment,...

The Associate Director, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to provide strategic oversight of laboratory deliverables across the portfolio, ensuring that study start timelines are met , provide risk management. Collaborates with stakeholders for all aspects of clinical laboratory deliverables (from study conduct, sample management testing to launch). This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.   As an Associate Director, a typical day may include the following:...

The Senior Director, Precision Medicine Strategy Lead role is critical for the successful execution of Regeneron biomarker strategies. Will be accountable for leading a team responsible for overseeing the development and execution of biomarker strategies for the burgeoning Oncology Portfolio in Clinical Development at Regeneron. This is a strategic role responsible for independently designing, developing, communicating at senior levels and overseeing the implementation of clinical biomarker strategies across key programs in early and late stage drug development. Further, this role is responsible for providing subject matter expertise to drive successful relationships with both internal groups at Regeneron as well as external KOLs. Oncology programs comprise nearly half of the overall growing Regeneron development portfolio, including novel modalities, targets and combination therapies. This role has a 3-day onsite minimum requirement in Armonk, NY or Basking Ridge, NJ. As a...

This is a hybrid position that requires 3 non-consecutive days on-site in Armonk, NY or Basking Ridge, NJ, and 2 days from home. A fully remote role is not possible for this position. The Associate Director, Strategic Facilitation will objectively lead discussions or workshops ensuring business objectives are reached efficiently and effectively. The Associate Director, Strategic Facilitation will help individuals and groups identify their purpose and articulate key actions they must take to ensure they realize their purpose, designing each experience utilizing tools and methodology that suits the required challenge, issue, and outcome. The Associate Director, Strategic Facilitation will project manage workshop outcomes as needed. The Associate Director, Strategic Facilitation will support the Director in the creation and leadership of a facilitation center of excellence and Community of Practice. In a typical day, you will: Design and manage complicated engagements that...

This is a hybrid position on-site 3 days per week in Armonk, NY or Basking Ridge, NJ and 2 days from home. A fully remote role is not possible for this position. The Senior Director, Transformation Program Management will play a vital role in the planning, execution and delivery of cross-functional and complex non-drug strategic and transformational initiatives for Global Development and other areas of Regeneron as requested. This role will collaborate closely with senior and executive leaders and stakeholders to drive the business transformation across the organization. The Senior Director Transformation Program Management communicates and collaborates with executive stakeholders and customers to ensure alignment and satisfaction. This role consults and negotiates with the Director Business Transformation Lead and Director Transformational Change & Engagement to translate business objectives into programs of work to be executed upon. This role requires a visionary leader...

The Medical Director, Clinical Sciences should be a qualified physician with pharmaceutical industry experience, preferably in Ophthalmology Therapeutics Development. The Director will serve as Medical Lead for clinical trials in the CDP and is responsible for the design of clinical study concepts leading to clinical trial protocols. This role requires a high-performing and highly passionate physician scientist who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research. As a Medical Director, a typical day may include the following responsibilities: Acts as medical expert and leader in interactions with external stakeholders Defines clinical trial-related Clinical Development Program (CDP) goals and objectives  Works closely with discovery teams to provide input on the next generation of targets in the field Responsible for the relevance and accuracy of medical science underpinning...

As a Senior Director in Pharmacometrics (PPK/PD, QP, or CP as appropriate), this individual will be responsible for managing PMx support for a number of programs in one or more therapeutic focus areas of the development portfolio. In this capacity the Senior Director is accountable for the successful and timely completion of all assignments encompassing a broad array of deliverables in support of the corporate strategic goals. The Senior Director is expected to apply both logistical and strategic initiatives as well as to incorporate novel and creative scientific approaches. A typical day in this role might look like: Utilizing a mastery level of PK/PD knowledge and strategic leadership skills, effectively develop and implement strategic analyses in support of research and development projects. • Adapts plans and priorities that addresses resource and operational challenges. Accountable for the appropriate application of PMx and corporate policies and procedure. • May...

Seeking experienced, rigorous, and innovative leader to head Regeneron’s Molecular Profiling Computational Data Sciences research team, consisting of approximately 35 dynamic researchers supporting all therapeutic areas, core technology groups and clinical development units at Regeneron in the design, generation and interpretation of high dimensional data sets from key platform technologies such as single cell RNA sequencing, bulk RNA sequencing, TCR/BCR sequencing and spatial transcriptomics. The position plays a key role in furthering Regeneron’s ability to advance our understanding of novel targets and biological pathways from discovery to clinical development.  Successful candidate would direct and inspire the Data Sciences team by using their deep and broad expertise in the computational biological sciences to set strategic vision, suggest novel technological approaches, and critically evaluate data and projects. Candidate would be expected to participate in...

The Senior Medical Director, Clinical Development will play a key role in the NASH/MASH clinical development program within the Regeneron Genetic Medicines portfolio, including responsibility for driving forward one or more NASH/MASH clinical programs. This role leads one or more clinical team working closely with key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs, clinical operations, and others. This role leads collaborations with discovery scientists and translational geneticist colleagues to understand current and emerging targets/genetic medicines programs, provides input on potential disease areas/indications, and crafts clinical experiments that corroborate or inform the biology for decision-making purposes and enable clinical development programs. This is an exciting opportunity to develope evolving Genetic Medicines modalities include RNA interference (RNAi), gene editing, viral vector gene delivery, and others. A typical...

The Senior Medical Director, Clinical Sciences, Endocrinology, will play a key role in clinical development programs within the General Medicine portfolio focused on obesity and related comorbidities. This role serves as Scientific and Medical Lead for Clinical team(s) working closely with Operational Leads to guide and execute clinical development strategies and subsequent regulatory submissions. This role requires a high-performing and highly passionate individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research. The Senior Medical Director General Medicine reports to an Executive Director, General Medicine. A typical day may include the following: Acts as medical expert and leader in interactions with external stakeholders Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and...

We are seeking a Director to join our Clinical Development team. The Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part of a cross-functional team and may contribute to drug-candidate development projects through early and/or late phase development. The Director reports to the Internal Medicine Clinical Development Unit Lead of Clinical Scientists and collaborates closely with Medical Director(s)to provide scientific expertise vital to design and deliver on clinical studies and programs. As a Director, a typical day may include the following: May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical Sub Team Contributes to program team meetings,...

The Clinical Imaging Scientific Director for Oncology will own the strategy and execution of sophisticated early and late phase oncology imaging in clinical trials where imaging plays a key role. Imaging includes all modalities with a special focus on PET and CT. In this role, you will champion the development of imaging endpoints and biomarkers and drive the scientific imaging aspects and tumor response assessment of oncology clinical studies. This position provides excellent opportunities to develop innovative imaging endpoints and biomarkers in support of clinical development and to contribute to bringing new treatment options to patients. As a Director in Clinical Imaging, a typical day may include the following: Create fit-for-purpose imaging biomarker strategies and work closely with research and clinical imaging, the oncology therapeutic area for the development of imaging endpoints to inform and advance the Regeneron clinical pipeline Prepare and present...