125 clinical quality lead jobs found

Merck Job Description TranslationalMedicine(TMed)drivesearly clinical development of novel therapeuticsby partneringwith Discovery Sciences and Late-Stage Clinical Researchto translatescientific discoveriesinto human proof-of-conceptandadvancethe most promising candidates through the pipelineto patients. Wedesign and execute clinical pharmacology strategiesspanningfirst-in-humanstudiesthrough proof-of-biology/proof-of-conceptandintolate-stage development,supportingworldwide marketingapplicationsand lifecycle management. In a competitive externallandscapeand fast-pacedinternalenvironment, this positionprovidesbothstrategicandoperationalleadership acrossearlyimmunologyprograms,ensuringtimely, high-quality execution of clinical studies and clinical pharmacology strategies worldwide.The successful candidate willtelescope betweenstrategy and hands-onexecution acrossa portfolio of diverse modalities (e.g. peptides, small molecules, biologics), andpartner cross-functionally to...

Merck Job Description TranslationalMedicine(TMed)drivesearly clinical development of novel therapeuticsby partneringwith Discovery Sciences and Late-Stage Clinical Researchto translatescientific discoveriesinto human proof-of-conceptandadvancethe most promising candidates through the pipelineto patients. Wedesign and execute clinical pharmacology strategiesspanningfirst-in-humanstudiesthrough proof-of-biology/proof-of-conceptandintolate-stage development,supportingworldwide marketingapplicationsand lifecycle management. In a competitive externallandscapeand fast-pacedinternalenvironment, this positionprovidesbothstrategicandoperationalleadership acrossearlyimmunologyprograms,ensuringtimely, high-quality execution of clinical studies and clinical pharmacology strategies worldwide.The successful candidate willtelescope betweenstrategy and hands-onexecution acrossa portfolio of diverse modalities (e.g. peptides, small molecules, biologics), andpartner cross-functionally to...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Nurse Case Manager Lead works closely with the Vice President, Patient Support Programs and is responsible for managing a team of Regional Nurse Case Managers who educate patients and caregivers as part of the argenx Patient Support...

Merck Job Description This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross-functional team. Job Responsibilities Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director. Other responsibilities include: Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with the protocol in...

Merck Job Description Summary This position contributes to the scientific planning and execution of one or more clinical trials. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical studies. In this position, you will have the opportunity to develop your leadership, technical skills, and scientific acumen as part of a global, cross-functional team. Job Responsibilities Responsible for specific clinical/scientific activities on a single study or across multiple studies (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials). Support development of Protocol and related study materials (e.g., ICF documents/amendments, data management deliverables). May interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives. Support development of site and CRA training materials Prepare...

Merck Job Description Summary This position contributes to the scientific planning and execution of one or more clinical trials. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical studies. In this position, you will have the opportunity to develop your leadership, technical skills, and scientific acumen as part of a global, cross-functional team. Job Responsibilities Responsible for specific clinical/scientific activities on a single study or across multiple studies (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials). Support development of Protocol and related study materials (e.g., ICF documents/amendments, data management deliverables). May interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives. Support development of site and CRA training materials Prepare...

Biogen About this role The Field Director, Medical Science Liaisons is a leadership role within US Medical Affairs and a strategic partner across Biogen. This role provides leadership, strategic direction, and operational excellence to a regional team of Medical Science Liaisons (MSLs), ensuring the effective translation and execution of medical strategy in support of meaningful patient outcomes. Biogen's priority is to continue to foster and enable a diverse and inclusive workforce - representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities - that reflects the communities where we operate and the patients who we serve. What You'll Do Strategic Planning & Execution Collaborate with Global Medical Directors, US and global brand teams, clinical partners, and crossfunctional stakeholders to develop and implement regional field medical strategies, translating enterprise and brand objectives into clear, actionable plans...

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 The Senior Director, DMPK will serve as the company's key expert overseeing DMPK strategy across the entire company, including late-stage discovery, development, NDA submission, and commercial readiness, as well as designing, implementing, and interpreting DMPK studies, ensuring high-quality data and regulatory-ready documentation to support IND, CTA, and NDA filings. As part of a growing biotech organization, the role requires a hands-on, collaborative leader who can build and guide a high-performing team while working cross-functionally to advance a dynamic portfolio. This is a...

Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your...

Alkermes, Inc. The Associate Director position within Clinical Supply Chain provides strategic leadership and oversight for end-to-end supply chain management across multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. Serving as the primary point of contact, the Associate Director collaborates closely with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel, leading complex supply activities that often require multinational coordination. Additionally, this role is responsible for building and maintaining strong partnerships with both internal and external stakeholders, ensuring alignment with organizational objectives. The successful candidate will demonstrate leadership in a highly collaborative team environment, driving the successful development and delivery of new drugs. Responsibilities Oversee, update, and monitor program budgets while ensuring...

Biogen This is a remote position that requires the candidate to be located in the United States. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management....

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Principal Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Zurich Switzerland Office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables Main Responsibilities: Input to statistical strategy and ensure appropriate statistical methodologies...

PerkinElmer Responsibilities Location Boston, Massachusetts US Job ID REQ-057006 This is a fully onsite role in Boston, MA with Project Farma, a PerkinElmer company Project Engineers (PE) and Senior Project Engineers (Senior PE) are fully billable roles that will work collaboratively with clients, vendors, contractors, and other Team Members to support projects related to biomanufacturing across the entire engineering lifecycle. PEs and Senior PEs are responsible for delivering high quality work, forming and maintaining valuable, long-term relationships with our clients, and continually strengthening their technical and industry knowledge. They will maintain a strong focus on Project Farma's Patient Focused and People First mindset. Key Responsibilities Site Strategy Support the execution of site strategy under the direction of the Site Lead, contributing to specific project tasks that align with Project Farma's services. Perform assigned tasks...

PerkinElmer Responsibilities Location Boston, Massachusetts US Job ID REQ-057005 This is a fully onsite role in the Boston, MA area with Project Farma, a PerkinElmer Company. Consultants and Senior Consultants are fully billable roles that will work collaboratively withclients, vendors, contractors, and other Team Members tolead andsupport projects related tobiomanufacturing across the entireprojectlifecycle.Specifically, theyare responsible forleading and mentoringsmall project teamsandidentifyingbusiness development opportunitiesthroughProject Farma's Patient Focused and PeopleFirst platform.Consultants and Senior Consultants are tactical executors focused on project-level delivery, supporting thesiteManager's strategy, and contributing to business growth, talent development, and resource planningwith an emphasis ontechnicalexpertiseand operational execution. Essential Functions: Site Strategy Executes the site strategy as defined by the Manager to...

Alkermes, Inc. We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Associate Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will provide strategic and tactical advice to teams to achieve support the development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. The ideal candidate will have a strong scientific background, and be able to leverage their experience to provide leadership within the department and across R&D. This role reports to the Senior Director, Head of Orexin Regulatory Strategy. Responsibilities Contribute to development of robust, global regulatory strategies for assigned projects. Accountable for adapting and maintaining the regulatory strategy as needed Develop submission plans and...

CSL The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system. You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain compliant with global regulations, ICH guidelines, and company standards. Your role bridges strategic oversight with hands on operational leadership: you design the audit strategy and governance framework that keeps the system fit for purpose, but you also own the day-to-day quality assurance of how PV actually works across the business. You will direct both the strategic evolution of the PVRQA function and its operational delivery. This means setting the long term compliance roadmap while simultaneously managing inspections, deviation management, and the practical quality controls that keep the system sound. You partner with senior leadership on strategic direction, but...

Biogen About This Role The (Senior) Study Data Tabulation Model (SDTM) Programmer will be part of the SDTM Development and Operations organization that is evolving and responsible for fulfilling all of Biogen's SDTM needs with presence in the Unites States and Europe. What You'll Do You will lead study level SDTM programming activities and deliverables (annotated Case Report Form (aCRF), specifications, datasets, define.xml, Study Data Reviewers Guide, etc.). Collaborating cross-functionally within Analytics and Data Science, you will work other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study. You will represent SDTM Development and Operations (Dev & Ops) in the Biogen Portfolio Disease Unit (DU) discussions. You will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities. Who You Are You are a Clinical SAS...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). Responsibilities encompass support to the development of the operational strategy for our most complex studies and ensuring achievement of all program goals within established timelines, budget, and quality standards, and according to the TA strategies. This role must be experienced in working in a matrix...

Alkermes, Inc. An exciting opportunity to lead the strategic and operational management of complex clinical supply activities across all phases of development to provide life-changing therapeutics for patients. The Senior Director of Clinical Supply Chain ensures the uninterrupted, compliant, and cost-effective delivery of investigational products to global clinical trial sites. The ideal candidate will bring deep expertise in supply chain strategy, vendor oversight, and cross-functional collaboration, with a strong understanding of GMP, IRT systems, and regulatory requirements. Responsibilities Strategic Leadership Develop and execute global clinical supply chain strategies aligned with corporate and clinical development goals. Lead long-range planning and drive the continued development and transformation of supply chain infrastructure to meet the needs of the growing business. Partner with Legal, Finance, Trade Compliance, Quality Assurance, Regulatory Affairs,...

Revvity Project Delivery Specialist Marlborough, MA / Diagnostics This position is a member of the global Product Development team who will support product development process activities and deliver on strategic company goals. As part of the global Product Development team, you will be expected to contribute to delivery of strategic goals and support product development activities globally. Contribute to project delivery for broader development projects (hardware, software, kit) and company process improvement initiatives. Provide support at the interface between Product Development and Quality, Regulatory, Clinical, Product Service and Support, and Manufacturing departments. Specific deliverables include: A key focus on supporting delivery of software focused projects. A focus on delivering and maintaining the Design History Files for company products. Support coordination and alignment of product requirements and deliverables across departments. Ensuring...