div class="content">Summary
The Senior Director of Clinical Operations oversees all aspects of clinical trial execution, including start-up, monitoring, and close-out activities for all ARTBIO programs. The Senior Director of Clinical Operations collaborates closely with cross-functional teams, including clinical development, project management, regulatory, quality, finance, and translational and discovery research, to drive the successful execution of clinical study plans.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Cambridge, MA30+ days ago
p>The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and will lead a team to drive the strategy and implementation of country and site feasibility for our studies and support the internalization of country and site feasibility. The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and lead a team to drive the strategy and implementation of feasibility and study start-up across all clinical programs.
Cambridge, Massachusetts19 days ago
ul>Program Oversight: Clinical operations leadership across assigned programs, including trial management, site monitoring, vendor selection and oversight, TMF, data operations, timeline and budget adherence. Team Leadership: Provide line management, coaching, and mentorship to assigned team members, as well as represent clin ops in various cross functional forums (Program team, sub-teams, etc).
li>Lead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high-quality delivery and accountability. Oversee Clinical Data Management and clinical trial technologies, ensuring high-quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
Cambridge, MA30+ days ago
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). Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
ul>Preference for at least one of the following fields of study: Accounting, Actuarial Science, Analytics/Data Science, Business Administration/Management, Computer Science/Information Systems, Economics, Engineering, Finance, Government/Public Policy, Health Administration/Public Health, Mathematics/Statistics, Operations/Supply Chain, Organizational Management/Behavior, Risk Management/Insurance. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
As Senior Clinical Operations Lead, you will hold strategic accountability for highly complex assets spanning multiple indications covering - including large Phase III global outcomes trials, rare disease programmes and co-development partnerships - across therapeutic areas including hepatology, renal and cardiovascular disease. Significant senior clinical operations leadership experience in a pharmaceutical or CRO environment, with a track record of delivering highly complex, multi-asset programmes across therapeutic areas including hepatology, renal and cardiovascular diseases.
p>In a competitive external landscape and fast-paced internal environment, the Immunology Clinical Operations Lead position provides both strategic and operational leadership across early immunology programs, ensuring timely, high-quality execution of clinical studies and clinical pharmacology strategies worldwide. Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients.
div>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
ul>Preference for at least one of the following fields of study: Accounting, Actuarial Science, Analytics/Data Science, Business Administration/Management, Computer Science/Information Systems, Economics, Engineering, Finance, Government/Public Policy, Health Administration/Public Health, Mathematics/Statistics, Operations/Supply Chain, Organizational Management/Behavior, Risk Management/Insurance. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Cambridge, MA30+ days ago
Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies.
Watertown, MA30+ days ago
This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Boston, Massachusetts6 days ago
div>Provide day-to-day support and maintenance for business-critical applications such as Veeva Vault Clinical Trial Management System (CTMS), Veeva Electronic Trial Master File (eTMF), and Elluminate Electronic Data Capture (EDC) platform, ensuring maximum uptime, high performance, and excellent customer service .
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
p>This role is ideal for someone who thrives in a fast-paced biotech environment, can independently lead complex global studies, proactively solve problems, and confidently navigate ambiguity while remaining hands-on and team-oriented. • Provide strategic oversight and leadership to cross-functional study teams including CTMs, CTAs, CRAs, vendors, and CRO partners.
Watertown, MA30+ days ago
This hands-on position will lead and support all aspects of clinical trial operations including planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations, including direct management of outside Clinical Research Organizations (CROs) for several clinical stage oncology assets. Maintain knowledge across the clinical operations team of program specific therapeutic areas, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities and appropriate communication to study sites.
Cambridge, Massachusetts30+ days ago
p>By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-dpartners.com/privacy-policy/. - Responsible for end-to-end execution of clinical supply activities including IRT, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout.
Cambridge, MA30+ days ago
p>Participates in reviews and provides direction on CRO and vendor outsourcing strategy and key performance indicators (KPIs) ensuring vendor CRO partners consistently deliver high-quality data to support regulatory requirements. Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems.
Accountabilities: Clinical Program Oversight: Lead end-to-end oversight of clinical program activities, advancing relevant issues to senior governance and providing clinical operations expertise in feasibility, country selection, operational input to design, risk management, and external partner management. Line Management: Provide line management to global clinical operational leaders at the study and program levels, including Global Study Associate Directors or Global Study Directors and Global Program Directors aligned to the product team's deliverables.
You will sit at the center of Hemabs clinical strategy and execution, owning end-to-end delivery across a growing global portfolio, from first-in-human studies to pivotal trials, while continuously finding smarter, faster, and more patient-centric ways to operate. Proactively identify and implement process innovations including novel trial designs, technology platforms, and decentralized/hybrid trial elements to accelerate timelines and improve patient access.
process SME).Essential Requirements:Relevant experience in pharmaceutical industry /biotech /CRO drug development environment with a solid understanding of drug development process, and early clinical development preferred1+ years'' experience in early phase clinical trials operations Solid knowledge of clinical trials site selection, global /country specific requirements, timelines and challenges in clinical trial execution processDesirable requirement: Successful completion of Academy fellowship programThe salary for this position is expected to range between $108,500 and $201,500 per year. Key Responsibilities:Provides operational and logistical support to clinical trials in Biomedical Research (BR) with focus on increased complexity and/or priority status, in compliance with Novartis processes and Good Clinical Practice (GCP).Perform defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support.
p>Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship''s scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Flagship has been recognized twice on FORTUNE's "Change the World" list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company's annual list of the World's Most Innovative Companies.
Watertown, MA30+ days ago
Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
ul>Preference for at least one of the following fields of study: Accounting, Actuarial Science, Analytics/Data Science, Business Administration/Management, Computer Science/Information Systems, Economics, Engineering, Finance, Government/Public Policy, Health Administration/Public Health, Mathematics/Statistics, Operations/Supply Chain, Organizational Management/Behavior, Risk Management/Insurance. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.