64 manager project management jobs found

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead. What You'll Do Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation. Act as the back up to the Clinical Data Lead, providing subject matter expertise and...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle. What You'll Do Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress. Accountable for all Data Management...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead. What You'll Do Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation. Act as the back up to the Clinical Data Lead, providing subject matter expertise and...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle. What You'll Do Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress. Accountable for all Data Management...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle. What You'll Do Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress. Accountable for all Data Management...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead. What You'll Do Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation. Act as the back up to the Clinical Data Lead, providing subject matter expertise and...

Biogen About This Role The Senior Manager, Insights & Analytics will play a critical role within the US Lupus team. You will be a proactive strategic thought partner for the US Brand team, responsible for driving actionable insights & deep understanding of the customer, overall market, and competitive landscape in both systemic and cutaneous lupus. This role plays a vital part in shaping the direction of the business and contributing to brand success. You will directly support the US Lupus brand team, focused on building foundational insights and building a go-to-market roadmap for one pipeline asset across multiple indications. You will provide critical insights for informed decisions, allowing for competitive positioning, and driving strategic initiatives based on an insights-driven approach. As a key partner to commercial and marketing leadership, you will help identify & address the most important business problems facing the franchise and help to develop...

Biogen About This Role: As the Manager of Supply Chain Planning within the Global Clinical Supply Chain team, you will be pivotal in overseeing Clinical Study level supply operations. Your primary focus will be executing the clinical protocol level planning for finished goods and managing distribution activities to support seamless execution of clinical trials, both ongoing and new. You will be tasked with translating clinical study designs into supply plans and ensure study level operations align with the dynamic shifts in demand of our clinical pipeline. You'll act as a single point of contact for internal clinical operations teams, Quality and Program teams. You will interface with external distribution partners and Clinical Research Organizations to oversee distribution activities. This is a hybrid role to based at our West Coast Hub in San Francisco, CA. What You'll Do: Develop and execute clinical supply chain plans to support First Patient In (FPI) targets...

Biogen About This Role: As a Senior Category Manager for Direct Materials, you will play a pivotal role in optimizing and innovating key categories crucial to Biogen's operational footprint. Reporting to the Associate Director of Global Strategic Sourcing, this position sits on the Global Strategic Sourcing team, focusing on the direct material space for internal manufacturing operations, including categories like chemicals, filters, and resins. You will be responsible for managing category strategies and sourcing initiatives across various modalities, such as Biologics, Oral Solid Dosage, Parenteral filling, ASOs, and Clinical Label & Packaging. This Senior Manager will ensure the needs of the business are met by leading category management, sourcing strategies, and sourcing process from defining business needs, knowledge of supply marketplace, executing RFx events, lead contract negotiations, supply risk management, and supplier relationship management. What You'll...

Merck Job Description We are seeking a motivated and experienced Translational PET Imaging Scientist to lead the transition of novel PET radiotracers from late preclinical development into first-in-human studies. This role will primarily focus on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project teams to ensure efficient clinical translation. Key Responsibilities: Strategy & leadership : Develop and lead the clinical imaging strategy for application of novel PET tracers in early clinical oncology trials, guiding projects from late-stage preclinical work through clinical proof-of-concept studies. Translational study design : Design, oversee, and interpret PET imaging studies in animal models and early-phase clinical trials (Phase I), ensuring robust study design and high-quality PET data collection. Regulatory support : Familiarity with...

Merck Job Description We are seeking a motivated and experienced Translational PET Imaging Scientist to lead the transition of novel PET radiotracers from late preclinical development into first-in-human studies. This role will primarily focus on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project teams to ensure efficient clinical translation. Key Responsibilities: Strategy & leadership : Develop and lead the clinical imaging strategy for application of novel PET tracers in early clinical oncology trials, guiding projects from late-stage preclinical work through clinical proof-of-concept studies. Translational study design : Design, oversee, and interpret PET imaging studies in animal models and early-phase clinical trials (Phase I), ensuring robust study design and high-quality PET data collection. Regulatory support : Familiarity with...

Biogen About This Role The Pharmaceutical Operations and Technology (PO&T) Division is seeking to fill the position of CMC Asset Lead. This role is a key member of the Asset Development & Portfolio Management (ADPM) team, which is responsible for providing cross-functional leadership for development programs, referred to as assets. The PO&T Asset Lead is entrusted with end-to-end leadership across all aspects of asset strategy, development, supply, and life cycle management for the Chemistry, Manufacturing, and Controls (CMC) components of clinical programs in biologics, pharmaceuticals, or other modalities. Specifically, the CMC Asset Lead will oversee one or more programs in pre-clinical to Phase 2 stages and may be required to manage corporate partners. This position is a hybrid role based in Cambridge, MA. What You'll Do Serve as the PO&T "asset owner" for early-stage programs, with full accountability for developing and delivering a five-year...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Vice President, Regulatory Affairs / Alliance Management The Company: With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Chief Development Officer, the Vice President of Regulatory Affairs / Alliance Management will serve as a senior regulatory leader, responsible for developing and...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Vice President, Regulatory Affairs / Alliance Management The Company: With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Chief Development Officer, the Vice President of Regulatory Affairs / Alliance Management will serve as a senior regulatory leader, responsible for developing and...

Biogen About This Role The Global Medical Director, Spinal Muscular Atrophy (SMA) will serve as a strategic partner and expert medical leader, guiding development, launch planning, execution, and ongoing support for Biogen's SMA program. The goal is to drive meaningful improvements in patient outcomes. As a key member of the global SMA medical affairs team, the Medical Director will help develop and implement the global medical strategy, reinforcing Biogen's leadership within the SMA medical community. Biogen is committed to fostering a diverse and inclusive workforce-representing differences in age, gender, sexual identity, race, ethnicity, Veteran status, and abilities-that reflects the communities we serve and the patients we support. What You'll Do Develop and implement the global SMA medical strategy and tactics in collaboration with regional/country and cross-functional teams. Lead the planning, development, and execution of high-impact medical...

Merck Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The Associate Director of Compliance, Digital Foundational Services, IT / OT Compliance Lead for West Point is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports to Foundational Services Compliance USA Regional Lead. Primary Responsibilities: Lead and/or support various site functional and cross functional structures for all computerized system validation and IT/OT compliance issues. Ensure supply and quality of all compliance components required to deliver high quality product through tactical...

Merck Job Description Designation: Associate Director, R4 Location: US Job Description: The PMO StrategicPlanning will support the execution of change management, communication, and training strategies, plans, and activities to ensure successful adoption of the S/4HANA migration program. This role focuses on assessing the impact of changes on business processes, supporting targeted behavior change, and preparing stakeholders for go-live readiness. The position requires strong analytical skills, communication expertise, and the ability to collaborate across multiple teams to deliver effective change and communication interventions. Key Responsibilities: Support the development and execution of change management strategies aligned with S/4HANA migration objectives. Assist in assessing change impacts on end-to-end business processes and support mitigation planning. Contribute to the design and delivery of communication plans to ensure stakeholder...

Merck Job Description Designation: Associate Director, R4 Location: US Job Description: The PMO StrategicPlanning will support the execution of change management, communication, and training strategies, plans, and activities to ensure successful adoption of the S/4HANA migration program. This role focuses on assessing the impact of changes on business processes, supporting targeted behavior change, and preparing stakeholders for go-live readiness. The position requires strong analytical skills, communication expertise, and the ability to collaborate across multiple teams to deliver effective change and communication interventions. Key Responsibilities: Support the development and execution of change management strategies aligned with S/4HANA migration objectives. Assist in assessing change impacts on end-to-end business processes and support mitigation planning. Contribute to the design and delivery of communication plans to ensure stakeholder...

Merck Job Description Designation: Associate Director, R4 Location: US Job Description: The PMO StrategicPlanning will support the execution of change management, communication, and training strategies, plans, and activities to ensure successful adoption of the S/4HANA migration program. This role focuses on assessing the impact of changes on business processes, supporting targeted behavior change, and preparing stakeholders for go-live readiness. The position requires strong analytical skills, communication expertise, and the ability to collaborate across multiple teams to deliver effective change and communication interventions. Key Responsibilities: Support the development and execution of change management strategies aligned with S/4HANA migration objectives. Assist in assessing change impacts on end-to-end business processes and support mitigation planning. Contribute to the design and delivery of communication plans to ensure stakeholder...

Merck Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The Associate Director of Compliance, Digital Foundational Services, IT / OT Compliance Lead for West Point is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports to Foundational Services Compliance USA Regional Lead. Primary Responsibilities: Lead and/or support various site functional and cross functional structures for all computerized system validation and IT/OT compliance issues. Ensure supply and quality of all compliance components required to deliver high quality product through tactical...