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Global Safety Program Lead/Sr Medical Director Alexion Pharmaceuticals Inc

Boston, MA

$280,895–$421,342 / year

Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset. Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.

30+ days ago

Director, Drug Safety & Pharmacovigilance Scientist Dyne Therapeutics Inc

Waltham, MA

$220,000–$240,000 / year

Role Summary: The Director, Drug Safety & Pharmacovigilance Scientist provides strategic and scientific leadership for safety surveillance, signal detection, benefit-risk evaluation, and risk management activities across Dyne's development programs. The Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making.

30+ days ago

Director, Medical Safety And Risk Management Alnylam Pharmaceuticals, Inc.

Cambridge, MA

Serve as the safety expert providing strategic input to key stake holders in relation to product safety, understand the business strategy for the product and be knowledgeable about the (medical) context of the respective product class. Safety Risk Management Teams) regarding safety relevant topics and escalate all relevant safety matters to the appropriate decision-making level with proposals for solutions based on analysis of the available information.

30+ days ago

Director, Medical Safety and Risk Management Alnylam Pharmaceuticals Inc

Cambridge, MA

$247,100–$334,300 / year

25 days ago

Principal Scientist (Scientific Director Level)- Nonclinical Drug Safety Merck & Co Inc

Cambridge, MA

$176,200–$277,300 / year

They are responsible for 1) providing risk assessments for targets, 2) de-risking strategies for discovery programs and 3) collaborating with NDS staff at other sites to execute on the appropriate studies to support selection of therapeutic targets, and the identification and development of new drug candidates. The Discovery Program Leader is responsible for defining and overseeing the NDS strategy for programs in all modalities (including small molecules, peptides, biologics and ADC programs) from Target Identification through to the approval of First-In-Human enabling GLP toxicity studies.

30+ days ago

Director, Quality & Safety Lahey Hospital and Medical Center

Newburyport, MA

$150,000–$190,000 / year

Reporting to the Chief Medical Officer and working in close partnership with the Chief Nursing Officer, Hospital President, medical staff leadership, and operational leaders, the Director of Quality & Safety is responsible for leading and overseeing a comprehensive quality, patient safety, regulatory, risk management, infection prevention, and patient experience program at Anna Jaques Hospital. Develop and support systems for tracking, evaluating, reporting, and improving quality and patient safety outcomes, Collaborate with physicians, nursing leadership, and operational leaders to reduce preventable harm and improve clinical outcomes.

30+ days ago

Senior Director, Safety Physician Amylyx Pharmaceuticals Inc

Cambridge, MA

Remote

$276,000–$310,000 / year

Reporting to the Vice President, Patient Safety and Pharmacovigilance, the Senior Director, Safety Physician will serve as a medical safety expert across assigned programs and products, partnering closely with colleagues across Clinical Development, Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics, and other functions. Experience supporting clinical-stage development programs required; experience supporting late-stage development, regulatory submissions, product launch, and/or marketed products strongly preferred.

30+ days ago

Senior Director, Safety Physician Amylyx Pharmaceuticals

Cambridge, MA

Remote

$276,000–$310,000 / year

30 days ago

Medical Director, Senior Patient Safety Physician AstraZeneca Plc

Cambridge, MA

$249,827–$374,740 / year

Working within a global, cross-functional environment, you will collaborate with experts across Clinical Development, Regulatory Affairs, Epidemiology, Safety Science, Risk Management, and Medical Affairs to protect patient safety and support the successful development and commercialization of innovative medicines. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

3 days ago

Senior Medical Director, Global Drug Safety Replimune

Woburn, Massachusetts

$307,000–$397,000 / year

This position provides pharmacovigilance expertise to and lead collaborations with external partners as well as with other functions across Replimune, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the Commercial to ensure that drug safety communications are accurate, complete and consistent. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.

30+ days ago

Medical Director, Global Drug Safety Replimune

Woburn, Massachusetts

The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

30+ days ago

Medical Director, Global Patient Safety Alexion

Boston, Massachusetts

$249,827–$374,740 / year

Representing Alexion GPS at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetings. Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required.

11 days ago

Associate Director, Safety Scientist Alexion

Boston, Massachusetts

The Associate Director, Safety Scientist plays a pivotal role within Global Patient Safety, providing strategic leadership and project management to proactively evaluate and manage safety risks in close collaboration with GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s). Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results.

12 days ago

Medical Director, Global Drug Safety Replimune Group Inc

Woburn, MA

$257,500–$333,500 / year

The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it.

30+ days ago

Senior Medical Director, Global Drug Safety Replimune Group Inc

Woburn, MA

$307,000–$397,000 / year

30+ days ago

Medical Director, Global Patient Safety Alexion Pharmaceuticals Inc

Boston, MA

Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required. Representing Alexion GPS at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetings.

30+ days ago

Associate Director, Safety Scientist Alexion Pharmaceuticals Inc

Boston, MA

$132,873.60–$199,310.40 / year

This is what you will do: The Associate Director, Safety Scientist plays a pivotal role within Global Patient Safety, providing strategic leadership and project management to proactively evaluate and manage safety risks in close collaboration with GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s). Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results.

11 days ago

Director Safety Physician BioNTech SE

Cambridge, MA

Oversees quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator's brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries, and other clinical/regulatory documents as needed. The MSP also ensures compliance with Good Clinical Practice (GCP) and regulatory reporting requirements, while contributing to essential safety documents such as Development Safety Update Reports (DSURs), updates to reference safety information, Investigator Brochures, and Clinical Trial Reports.

30+ days ago

Director, Takeda Safety Board Office 3316 Takeda Development Center Americas

Cambridge, Massachusetts

$177,000–$278,080 / year

Partners with Global Project Leaders, Global Safety leads, PSPV Therapeutic Areas Heads, and other senior leaders to collect and analyse information supporting the decision-making process to trigger a TSB interaction (e.g. As a member of the Strategy and Operations Team, provides input to key strategic & portfolio activities that may include: Project management support for DQS initiatives, change-management activities and organization of department meetings.

23 days ago

Director, Global Safety Lead Les Laboratoires Servier SAS

Boston, MA

$248,000–$299,000 / year

Spearhead signal detection activities, including kick off activities, planning, safety data retrieval and analysis, authoring some sections of the Safety Evaluation Report (SER) or Development Safety Evaluation Report (DSER), etc. for development and marketed compounds. Responsibilities include medical review, participation in drug safety related activities associated with clinical development, signal detection and evaluation, preparation of aggregate safety reports, and contributions to benefit-risk assessments and safety risk management strategies.

30+ days ago

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Sales Jobs in Roxborough, CO

Global Safety Program Lead/Sr Medical Director Alexion Pharmaceuticals Inc

Director, Drug Safety & Pharmacovigilance Scientist Dyne Therapeutics Inc

Director, Medical Safety And Risk Management Alnylam Pharmaceuticals, Inc.

Director, Medical Safety and Risk Management Alnylam Pharmaceuticals Inc

Principal Scientist (Scientific Director Level)- Nonclinical Drug Safety Merck & Co Inc

Director, Quality & Safety Lahey Hospital and Medical Center

Senior Director, Safety Physician Amylyx Pharmaceuticals Inc

Senior Director, Safety Physician Amylyx Pharmaceuticals

Medical Director, Senior Patient Safety Physician AstraZeneca Plc

Senior Medical Director, Global Drug Safety Replimune

Medical Director, Global Drug Safety Replimune

Medical Director, Global Patient Safety Alexion

Associate Director, Safety Scientist Alexion

Medical Director, Global Drug Safety Replimune Group Inc

Senior Medical Director, Global Drug Safety Replimune Group Inc

Medical Director, Global Patient Safety Alexion Pharmaceuticals Inc

Associate Director, Safety Scientist Alexion Pharmaceuticals Inc

Director Safety Physician BioNTech SE

Director, Takeda Safety Board Office 3316 Takeda Development Center Americas

Director, Global Safety Lead Les Laboratoires Servier SAS

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