Senior Director, Clinical QA & Audit Strategy
Korro Bio, Inc.
Korro Bio, Inc. is seeking an Associate Director, Clinical QA in Cambridge, MA to provide hands-on quality oversight for clinical and nonclinical programs, ensuring compliance with GCP, GLP, and GCLP. The role includes audits of CROs, laboratories, and sites, plus leading quality initiatives across study teams. You will partner with Clinical Operations, Regulatory Affairs, and Data Management, traveling up to 20% domestically and internationally, to protect patient safety and data integrity #J-18808-Ljbffr Korro Bio, Inc.
$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level... ...clinical trials, including risk-based audit strategy, quality risk identification, issue... ...candidate brings direct, hands-on GCP QA experience supporting clinical trials...SeniorFull timeSummer workRemote workFlexible hours2 days per week$155k - $225k
...range of therapeutic editing strategies that Beam is using to... ...Position Overview: The Senior Manager / Associate Director of Clinical Quality Assurance (CQA)... ...quality investigations, audits, CAPAs, and inspection readiness... ...outsource. Support QA leadership for...SeniorFull time$137k - $215.27k
...quality assurance oversight of the global clinical research programs in Research and... ...defines and implements a risk-based program audit strategy, ensuring communication of significant... ...and recommend appropriate solutions to senior management for immediate and long-term...SeniorMinimum wageWork at officeLocal areaImmediate startNight shift- ...in Boston, MA seeks an experienced Head of Clinical Data Management to lead one or more TAUs. You will define vision, drive strategy, and ensure on-time, high-quality data delivery... ...I&D and GDO objectives. This role demands senior leadership, deep DM expertise across Phase...Senior
- ...Beam Therapeutics seeks a Senior Manager/Associate Director of Clinical Quality Assurance to lead vendor qualification... ...service providers, manage audit strategies, and provide quality support across... ...inspection readiness Provide clinical QA support for assigned studies...Senior
- ...Regeneron seeks a Senior Director to lead clinical trial liaison strategy within Global Clinical Operations. This senior leadership role directs multi-region field operations, manages a global team, and aligns portfolio-wide clinical support strategy across the organization...Senior
- ...member of the GVP QA team providing Quality... ...system, including clinical safety, full... ...execution of the GVP audit program as well as... ...reports to the Director, Global PV Quality... ...Responsibilities: Senior Manager, PV QA supports... ...risk-based audit strategy and maintain and...SeniorWork experience placementRemote workWorldwide
$201k - $351k
The Opportunity: The Medical Director, Patient Safety & Risk Management... ...of risk minimization strategies to ensure patient safety and... ...and leader in cross functional clinical program teams, including Clinical... ...ready and serve as SME in audits and inspections. Serve as back...SeniorPrivate practice- Pfizer Oncology is seeking a Senior Medical Strategy Management Project Manager to lead and oversee cross-functional medical programs across the portfolio. You will manage timelines, budgets, risks, and stakeholder communications within the Medical Strategy Management Group...Senior
- ...Tango Therapeutics seeks a Director of GCP & GLP Quality Assurance... ...to oversee compliance across clinical trials and nonclinical laboratory... ...in Boston. This role leads audit strategy, vendor management,... ...systems, and processes Provide QA oversight of GLP studies at contract...SeniorContract work
- ...excellence, overseeing critical audit programmes, vendor quality,... ...activities. R&D Partners is seeking a Senior Manager, Global... ...This role focuses on auditing, QA operations, and supporting GVP... ...CAPAs. Support risk-based audit strategies and maintain the PV audit universe...Senior
$174k - $292k
Position description:The Director/Senior Director of Clinical Pharmacology serves as Clinical Pharmacology Lead on drug development teams. The successful candidate will lead clinical pharmacology strategy, planning, and delivery for assigned programs and clinical studies...SeniorFlexible hours$257.6k - $404.8k
...empowered to take charge of your future at Takeda. Join us as a Senior Medical Director, Clinical Science Neuroscience, in our Cambridge, MA office. At... ...missionOBJECTIVES:The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical...SeniorMinimum wageWork at officeLocal areaRemote workNight shift$203.21k - $304.82k
...Introduction to role Shape the evidence that determines which medicines reach patients—and how quickly As Senior Director, Oncology Clinical Intelligence & RWE Strategy, you will lead the Lung and HNSCC Therapeutic Area, setting the strategic direction for how clinical...SeniorFull timeTemporary workWork at officeImmediate startFlexible hours3 days per week$276k - $414k
...DescriptionGeneral Summary:The Patient Safety Senior Medical Director will provide leadership for all safety... ...representation, as safety lead, on clinical teams/programs, regulatory filings and... ..., including process/SOP development, audits and inspections.Key Duties and...SeniorFull timeSummer workRemote workFlexible hours2 days per week$266k - $344k
...Medicines: Beeline Medicines is a clinical-stage biotechnology company focused on... ...live life fully. Job Summary: The Senior Director, Clinical Pharmacology provides... ...development programs, directing PK/PD strategy, modeling and simulation, and dose-selection...SeniorLocal areaFlexible hours2 days per week$274.4k - $411.6k
..., in the Fenway area of Boston, Massachusetts.Summary The Senior Director, Clinical Development will provide medical and scientific leadership... ...for Tango’s oncology development programs, driving clinical strategy from early-stage development through registration....Senior$174k - $292k
...Relay Therapeutics seeks a Director/Senior Director of Clinical Pharmacology to lead clinical pharmacology strategy and execution across drug development programs. The role involves directing clinical pharmacology planning, regulatory interactions, and technical oversight...Senior- Actalent is seeking a Senior Manager to lead RBQM strategies for clinical trials, overseeing risk management and central monitoring to align with study complexity... ...cross-study risk initiatives, and contributing to audit readiness, with a remote-friendly setup based out of...SeniorRemote job
$185.6k - $232k
...benefits, see our website: The Importance of the Role The Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical... ...development and execution of the quantitative pharmacology strategies across all stages of drug development through product...Full timeRemote work$186.01k - $279.02k
...oncology? This role leads a connected evidence strategy spanning R&D through patient care, where... .... Can you see yourself guiding senior stakeholders through complex trade-offs... ...the interface of Translational Science, Clinical Development, and Market Access leading without...Full timeTemporary workWork at officeImmediate startWorldwideFlexible hours3 days per week$200k - $250k
...The RoleWe're looking for a Director of Clinical Affairs who will own the end... ...prepare for FDA submissions and audits, and drive studies to... ...legal teams to ensure clinical strategies align with product development... ...by supporting your RA/QA peers in the creation of pre...Full timeContract workImmediate startWorldwideNight shift$280.6k - $420.8k
Job DescriptionGeneral Summary:The Senior Medical Director will define the clinical development strategy of povetacicept in primary membranous nephropathy, work with cross-functional multidisciplinary teams to define overall asset strategy as well as clinical trials strategy...SeniorFull timeSummer workRemote workFlexible hours2 days per week$282.2k
Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in... ...and studies, including development strategy, study design, initiation, execution,...SeniorFull timeFor contractorsLocal areaFlexible hours$282.2k
Job DescriptionThe Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research... ...New Drug applications.Developing clinical development strategies for investigational or marketed Hematology drugs.Planning...SeniorFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours$305.7k - $413.7k
...opportunity to provide clinical leadership in developing... ...assets evolve. The Sr. Director is expected to play a... ...overall clinical development strategies and drive progress and... ...programs.The Senior Director, Clinical Research... ...Preclinical, Commercial & QA teams to ensure fully...SeniorFull timeTemporary workLocal areaFlexible hours$210.9k - $379.2k
...experienced oncology drug developer lead Clinical Development for one or more mRNA-based... ...ScientistsScientific Leadership, Direction and Strategy: Employs visioning and strategic... ...rulesOversee activities leading to internal cGCP audits and regulatory inspections related to...SeniorPermanent employmentFull timeWork at officeWork from home$210k - $300k
...Opportunity Overview Rhythm Pharmaceuticals is seeking a Senior Director, Clinical Pharmacology with demonstrable experience and expertise... ...small molecule and peptide mono- and combination-therapy strategies to join our development team. The successful candidate will...SeniorFull timeWork at office- Aditum Bio is seeking a Senior Director, Clinical Operations to lead strategic and operational planning for assigned early-stage clinical development... ..., this role will independently lead clinical operations strategy for first-in-human and Phase I/II studies, partnering with...Senior
$155k - $303k
...Water Street Boston, Massachusetts 02109 United States | Full-time As a Senior Principal, you will actively participate in the growth and development of the Management Consulting and Strategy practice at Publicis Sapient. Your role will focus on shaping goal-oriented...SeniorFull time
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