41 personal risk jobs found

Merck Job Description The Executive Director, Customer Service Center Strategy & Ops Leader (ED, CSC) reports to the Associate Vice President of US Marketing Operations in Commercial Excellence & Innovation and leads the overall US Customer Service Center organization with accountability to direct the strategy and execution of engagements with Healthcare Professionals, Patients, Consumers, and Employees across five contact centers with primary focus in the US. This accountability extends to include operational performance, regulatorycompliant intake, and largescale service modernization. This role directs a complex, multilayered organization of approximately 80 Full Time Employees, including multi-level leaders, people managers, and frontline teams responsible for critical, highly regulated customer and patient interactions. The ED, CSC sets the vision, strategy, and governance for a critical service organization that supports Healthcare Professionals, consumers,...

Merck Job Description The Executive Director, Customer Service Center Strategy & Ops Leader (ED, CSC) reports to the Associate Vice President of US Marketing Operations in Commercial Excellence & Innovation and leads the overall US Customer Service Center organization with accountability to direct the strategy and execution of engagements with Healthcare Professionals, Patients, Consumers, and Employees across five contact centers with primary focus in the US. This accountability extends to include operational performance, regulatorycompliant intake, and largescale service modernization. This role directs a complex, multilayered organization of approximately 80 Full Time Employees, including multi-level leaders, people managers, and frontline teams responsible for critical, highly regulated customer and patient interactions. The ED, CSC sets the vision, strategy, and governance for a critical service organization that supports Healthcare Professionals, consumers,...

Merck Job Description The Executive Director, Customer Service Center Strategy & Ops Leader (ED, CSC) reports to the Associate Vice President of US Marketing Operations in Commercial Excellence & Innovation and leads the overall US Customer Service Center organization with accountability to direct the strategy and execution of engagements with Healthcare Professionals, Patients, Consumers, and Employees across five contact centers with primary focus in the US. This accountability extends to include operational performance, regulatorycompliant intake, and largescale service modernization. This role directs a complex, multilayered organization of approximately 80 Full Time Employees, including multi-level leaders, people managers, and frontline teams responsible for critical, highly regulated customer and patient interactions. The ED, CSC sets the vision, strategy, and governance for a critical service organization that supports Healthcare Professionals, consumers,...

Merck Job Description The Executive Director, Customer Service Center Strategy & Ops Leader (ED, CSC) reports to the Associate Vice President of US Marketing Operations in Commercial Excellence & Innovation and leads the overall US Customer Service Center organization with accountability to direct the strategy and execution of engagements with Healthcare Professionals, Patients, Consumers, and Employees across five contact centers with primary focus in the US. This accountability extends to include operational performance, regulatorycompliant intake, and largescale service modernization. This role directs a complex, multilayered organization of approximately 80 Full Time Employees, including multi-level leaders, people managers, and frontline teams responsible for critical, highly regulated customer and patient interactions. The ED, CSC sets the vision, strategy, and governance for a critical service organization that supports Healthcare Professionals, consumers,...

Biogen About This Role: As the Associate Director, Field Clinical Engineering, you will play a pivotal role in the Implantable Device Unit, supporting the Head of Device Clinical. This position is integral to the development and daily management of field clinical activities, leading the Field Clinical Engineering (FCE) team. You will be at the forefront, interacting with neurologists, surgeons, and other stakeholders, fostering robust relationships with investigators and key opinion leaders. Your leadership will be crucial in hiring, developing, and motivating the FCE team, ensuring a culture of accountability and professional excellence. By coordinating field operations and serving as a key contact for clinical issues, you will act as a bridge between clinical research, commercial sites, and internal stakeholders. Your collaboration with Device Development, Clinical, Regulatory, and other teams will ensure the successful execution of clinical trials, contributing...

Merck Job Description This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. This position will interact with cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements. Principal Responsibilities Lead/contribute to device...

Merck Job Description We are seeking a highly motivatedsenior level scientist to develop and lead a discovery portfolio focused on neglected tropical diseases (NTDs), with a primary focus on Malaria, TB, and AMR. The successful candidate will shape scientific strategy, drive target and lead identification, and progress innovative therapeutic concepts from early discovery toward development. This role requires strong scientific depth, strategic thinking, and the ability to work effectively in multidisciplinary, matrixed teams. The candidate will also have to work to secure funding through external partnerships. Depending on level and experience, the role will have increasing expectations for scientific leadership, strategic impact, and portfolio ownership. Key Responsibilities: Scientific and Portfolio Leadership Develop and own a coherent neglected tropical diseases (NTDs) discovery strategy aligned with organizational goals, focusing on high-burden diseases...

Biogen The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level...

Biogen The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Biogen About This Role: As Biogen's Access Management Service Delivery Manager (SDM) you are the Access Management subject matter expert and services leader for all Access Management activities at Biogen. This role is accountable for delivering value to global stakeholders - which includes access services to every application in Biogen. A peer to this role is the Service Delivery Manager of Identity. This role is a direct report of the Global Leader of Identity and Access Management and is a member of the extended leadership team within the Cybersecurity organization. As Access Management SDM, you are responsible for establishing access management policies and standards and keeping them current. You are responsible for the planning and execution of initiatives that improve access management capabilities - both central platforms or efforts supporting independent stakeholder applications. This role is responsible for the entire service delivery process, from planning and...

Biogen 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. In alignment with established procedures and SOPs, the Senior Manager, CTL, leverages their phase, indication and operational expertise to independently oversee one or more clinical studies, including: Partnering with cross-functional representatives to drive the development of operationally feasible and robust protocol designs, ensuring that principles of patient focus, risk management, quality and scientific integrity are applied, exercising appropriate budget responsibility and focused, endpoint-driven cost consideration Developing and implementing the study-level operational strategy, cascading key operational aspects from the Integrated Development Plan and...

Biogen This position is hybrid to our Cambridge MA location and requires frequent on-site presence About This Role: As the Associate Director, US Forecasting, you will be a vital member of the Decision Sciences - Forecasting Center of Excellence team, tasked with developing and maintaining precise forecast models for Biogen North America's franchises. Your expertise will drive accurate predictions using both primary and secondary data assets, offering valuable insights for strategic planning and resource allocation across multiple indications. This role involves cross-functional collaboration to gather inputs, socialize outputs, and execute sensitivity and ad hoc analyses. You will empower the business to build objective forecasts and scenarios that enable data-driven decisions, maximizing shareholder value. Reporting to the Senior Director, Forecasting COE, this position offers a blend of analytical, strategic, and operational work, allowing you to engage with stakeholders...

Biogen About This Role The Senior Director, Development Asset Lead (DAL) is responsible for leading one or more preclinical or clinical-stage assets within Biogen's development portfolio. This role provides strategic, cross-functional leadership to maximize asset value and ensure effective execution of the integrated asset plan (IAP). The DAL partners across research, development, and commercial functions to align scientific strategy, operational execution, and business considerations such as time, risk, and value. As leader of the asset team, the DAL drives development strategy, oversees progress toward key milestones, and represents the program within governance forums. This role reports to the Head of Development Asset Leadership and is responsible for guiding the most complex or late-stage assets, including programs approaching regulatory filing or major stage-gate decisions. What You'll Do Lead development and continuous refinement of the integrated asset plan to...

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. The Role: Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

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. The Role: Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

Biogen About This Role: As a Senior Pharmacovigilance (PV) Lead, you will provide strategic and operational PV/safety support for Biogen's West Coast Hub development programs, working closely with cross-functional colleagues. This Director level position is pivotal in overseeing global safety operations, ensuring high-quality pharmacovigilance deliverables, and offering expert guidance across the organization. You will manage internal and external PV resources, lead cross-functional safety governance, and serve as a subject matter expert for safety strategy across clinical development, regulatory filings, and post-marketing activities. This role is integral to the business structure, fostering collaboration and advancing the strategic safety objectives of the organization. What You'll Do: Manage internal PV personnel and external resources, including full oversight of all PV vendor activities to ensure operational excellence and compliance. Build (where applicable) and...

Biogen About This Role The Biomarkers and Systems Biology group is seeking a highly motivated Senior Scientist to join a dynamic team responsible for developing and executing bioanalytical strategies across multiple therapeutic programs. This role is central to the development, optimization, and validation of bioanalytical assays supporting early and latestage clinical studies. The Senior Scientist will lead immunogenicity strategy, provide scientific oversight of CROexecuted assays, and contribute to global regulatory submissions. The ideal candidate has deep expertise in pharmacokinetic and immunogenicity bioanalysis, with additional experience in biomarker methods. Handson assay development experience across multiple platforms and a strong understanding of regulatory expectations are essential. The role requires scientific rigor, sound judgment, and the ability to operate effectively in a fastpaced biotech environment. What You'll Do Lead development,...

PhRMA Overview Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Deputy Vice President for its Policy and Research team to support PhRMA’s research strategy in support of PhRMA policy positions and analysis on the federal budgetary and economic impacts of U.S. federal and state policy reforms on the market for prescription medicines, including implications for access to care, utilization, spending, coverage, and reimbursement. The individual will report to the Deputy Vice President who oversees the Research Unit, as well as other staff across the organization to support the development of PhRMA policy positions and strategy. Key areas of focus will be to develop and manage research and analysis to shape a policy and regulatory environment that supports a competitive market for prescription medicines, improves patient access to care, and sustains future innovation. This highly visible role requires extensive collaboration across PhRMA and with member...

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. The Role: Reporting to the Chief Legal Officer, the VP, Compliance, will serve as the company's senior compliance leader, responsible for designing, implementing, and overseeing a comprehensive and effective global healthcare compliance program aligned with applicable laws, regulations, and industry standards. The role is both strategic and hands-on: ideal for a leader who can set vision while rolling up their sleeves to build processes from the ground up. The VP, Compliance will be a trusted advisor to Nuvalent leadership and a partner across business units. Responsibilities: Partner...