73 management jobs found in New York, NY

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities...

The Head of Clinical Data Management (CDM) is fully accountable for all clinical data management activities in support of the clinical pipeline. This includes, but is not limited to, execution and ownership of the CDM operating model, oversight of internal staff and external CDM partners, and cross-functional leadership for the delivery of high quality and reliable clinical data to enable internal decision making, regulatory approval, and market acceptance. The incumbent interacts with senior level management, partners with external vendors, collaboration partners and provides cross functional strategic direction and is accountable for building and managing a team across functions to identify risks and opportunities as well as innovative approaches to clinical data management. The Head of Clinical Data Management is critical to the success of our clinical trials and the integrity of data that supports regulatory submissions and decision-making. In this role, a typical...

Summary As an Associate Director of Publications Management, you will lead cross-functional publication teams to develop, manage and implement the publication plan of one or more therapeutic areas. You will build and update publication plans, and provide summary reports to partners. Job Duties A typical day may include the following: Leading cross-functional publication teams with company partners to develop, manage and implement the strategic medical publication plans in Hematology. This will involve the timely and efficient development and submission of manuscripts, abstracts, and meeting presentations. Guide and have oversight of publication vendors, contract writers and editors, draft budgets, and travel to conferences as needed. Develop a firm scientific understanding of the Hematology therapeutic area; additionally, should possess an understanding of clinical study design, statistics, and pharmaceutical research and development. Familiarity with...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks,...

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities within...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The role of Senior Manager, Diagnostics Program Management & Operational Delivery, is expected to manage and deliver a portfolio of diagnostic projects (CDx, IVD, etc.) within Regeneron’s drug development pipeline in close partnership with Diagnostic Strategy Leads and IVD Regulatory. This role includes portfolio management, program/project management and operational execution of complex diagnostic strategies to support clinical programs across a variety of therapeutic indications. The successful candidate will work cross-functionally within Diagnostic team, Precision Medicine and other functions internally to anticipate and meet the needs of these programs as well as ensure seamless delivery to milestones. Additionally, this role will serve as a key point of contact with external diagnostic partners, laboratories and vendors required to support development and delivery of the diagnostic strategies. As a Senior Manager, a typical day may include the following:...

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...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.       JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An...

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis. Clinical Practice Liaison, Endocrinology The Clinical Practice Liaison, Endocrinology (CPL) plays a vital field-based role within Madrigal’s Medical Affairs team, focused on improving the standard of care for patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH/NASH/MASLD). The CPL will proactively engage healthcare professionals (HCPs) to provide guideline-based, non-promotional disease education on the identification, diagnosis, and management...

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core...

At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Pharmaceutical Sales Specialist for the Primary Care Team, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives! Accountabilities                                                                                              •...

Job Description Summary The Pharmacy Specialist is a resource for the execution of the Medication Delivery Systems clinical business strategy. The technical and informative support provided by the Pharmacy Specialist helps to differentiate the Hazardous Drug Safety product portfolio to our customers through a peer-to-peer strategy. The expertise and credentials of the Pharmacy Specialist strengthens the validity of the recommendations for customers and leverages the pharmacy expertise to optimize the conversion process. This support is delivered through standardized methodology, conversion management,and facilitating education and training. The Pharmacy Specialist reports directly to the Regional Sales Manager. This position is a Job Group 3. Job Description We are   the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of...

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...

The Senior Manager Clinical Scientist Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Sr. Manager reports to Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a typical day may include the following: Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam Develops/maintains...

Regeneron Pharmaceuticals Inc. is seeking a Director Patent Attorney to develop global IP strategies around key molecules, platforms and other technologies to ensure Regeneron’s long-term competitive advantage. This unique in-house opportunity will be part of a high-performing team of IP practitioners devoted to protecting Regeneron’s innovations derived from Regeneron’s cutting-edge science and numerous collaborations, including over 75 collaboration agreements executed in the past 5 years. The patent attorney will enable key synergistic collaborations and acquisitions by providing IP transactional and due diligence support in close partnership with colleagues in the R&D, clinical, regulatory, legal, business and alliance management departments at Regeneron. This role will also advise on emerging legal issues, including monitoring and reviewing case law and legislative developments, and is expected to contribute to administrative and legal projects intended to develop an IP...