Associate Director, CMC Operations & Program Delivery
Kailera Therapeutics, Inc.
Kailera Therapeutics, Inc. in the United States seeks an experienced Associate Director, CMC Operations to drive planning and execution across CMC workstreams, from development through regulatory submission.
The role partners with CDMOs, technology transfers, and manufacturing, building integrated timelines and budgets in a fast-paced, hub-based environment. The position requires strong leadership, cross-functional collaboration, and a track record of delivering complex programs on time.
#J-18808-Ljbffr$175k - $200k
...cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy... ...us on X, LinkedIn and Facebook.Role Summary:The Associate Director, Talent Acquisition Operations & Programs leads the systems, programs, processes,...SuggestedInternshipLocal area- ...and pain. Our Phase 3 azetukalner program represents the most advanced, clinically... ..., corporate, and commercial operations. About the Role: We are seeking an Associate Director/Director, Development Program Management, CMC to join our team. The Associate Director...SuggestedTemporary workWork at officeRemote work2 days per week
$172.2k - $233k
...an experienced leader to serve as Associate Director, CMC Technology Delivery to lead the digital enablement and... ...strengthen compliance, and enhance operational performance to help Alnylam CMC... ...sciences, CMC statistics and CMC program management from preclinical to clinical...SuggestedFull timeContract workTemporary workLocal areaFlexible hours3 days per week$195k - $330k
...you’ll make an impact:Drive end-to-end CMC program management for mid to late-stage programs... ...Coordinate preparation, review, and on-time delivery of CMC components for global regulatory... ...with 10+ years of CMC experience; Sr. Director level requires commensurate additional...Suggested- ...Associate Director, Supply Chain OperationsGenerate:Biomedicines... ..., Supply Chain Operations plays a key operational... ...Biomedicines' clinical programs by supporting the... ...clinical trial material delivery for Phase II/III studies... ...Regulatory Affairs, CMC, and Quality, as well...SuggestedShift work
$191k - $242k
...organized and execution-oriented Associate Director / Director, Pre-Clinical Program and Alliance Management to drive the operational planning, integration, and delivery of pre-clinical programs from... ...functional activities across research, CMC, nonclinical safety/toxicology,...Work at office$141.7k - $173.19k
...pipeline, this newly created role reflects the organization's commitment to operational excellence, scalable project management, and digital transformation within CMC.The Manager, the CMC Program Operations will serve as the operations and digital enablement lead for CMC...Full time- ...credit credentials, high school programs, and new degrees, all while... ...and Workforce Impact. Operating in a dynamic environment, UC... ...Tufts Pre-College Programs Director and Associate Director, the Associate... ...to support seamless program delivery and a positive student experience...Contract workTemporary workSummer workWork at office
- ...Available Position: Associate Director, Global Clinical Operations Job Title: Associate Director, Global Clinical... ...timelines, budgets, quality standards, and program objectives. Develop, maintain,... ..., Regulatory, Data Management, CMC, Quality, and Translational...Remote work2 days per week3 days per week
$155k - $190k
...team. What You’ll Do: The Associate Director/Director, Program Management will collaborate... ...‑clinical, and technical operations, to lead regional and global... ..., preparation, and delivery of compliant marketing authorization... ..., Clinical, Quality, CMC, Medical Writing) Oversee...Full timeLocal areaFlexible hours3 days per week- ...unmet need. The company’s lead program, DMR-001, is an... ...pipeline. Position Summary The Associate Director, Statistical Programming serves... ...reporting, nonclinical, and CMC studies as needed. Key Responsibilities... ...Program Leadership and Delivery Serve as the statistical...For contractors
- ...focusing on the cell-type specific delivery of genetic medicines. It's... ...is launching a new clinical program, and we're looking for an Associate Director of Clinical Operations to help build it from the ground... ...Preclinical, Regulatory, and CMC to take an early-phase study from...Work at office
$141.7k - $173.19k
...Intellia Therapeutics seeks a Manager of CMC Program Operations to lead operational excellence and digital transformation for chemistry, manufacturing, and controls teams. The role combines project management oversight with AI-enabled tool design to enhance visibility...- Role: CMC Program Operations Manager leading digital transformation and operational excellence in biopharma, specifically within cell & gene therapy development. Responsibilities Develop and maintain integrated project plans, design AI-enabled tools to automate reporting...
$142.73k - $237.88k
...Solutions team is charged with the delivery of robust, patient‑centric... ...looking for an enthusiastic Associate Director to integrate technical... ...technical success of development programs through design of suitable... ...other sites. #GSK-LI Skills CMC Strategy, Data-Driven...Contract workLocal area- ...to achieving this goal every day.Reporting to the Program Lead for the TED portfolio, the Associate Director, Program Management will support the coordination... ...efficient execution, prioritization, risk management, and delivery of key program milestones. Communication of...Temporary workWork at officeLocal areaImmediate start3 days per week
$160k - $275k
...seeking an experienced and strategic Associate Director or Director of Statistical Programming to lead programming efforts for... ..., Data Management, Clinical Operations, and other cross-functional teams... ...data transfers and the delivery of required outputs.Oversee CROs...$171.5k - $214.42k
...Sclerosis (MS). Zenas’ earlier stage programs include ZB021, a clinical-stage, potentially... ...TRUE Innovation!Position Summary:The Associate Director, Statistical Programming will... ...Biostatistics, Data Management, Clinical Operations) to provide expert programming support...Contract workFlexible hours$184.07k - $198.8k
The Associate Director of Statistical Programming, as a member of the Biostatistics & Statistical Programming Department, will contribute to Alkermes to achieve... ...and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the...Work at officeLocal areaFlexible hours3 days per week$139.43k - $232.38k
Associate Director, Global Program Management (Oncology)At GSK, we have bold ambitions for patients, aiming... ...manage uncertainty, and accelerate delivery of critical milestones. Continuously... ...as an organization.The PPM can also operate at program level, as when a commercialization...Full timeLocal area$155.2k - $194k
...in Multiple Sclerosis (MS). Zenas’ earlier stage programs include ZB021, a clinical-stage, potentially best-... ...Innovation - TRUE Innovation!Position Summary:The Associate Director, Program Management provides operational support for one or more Zenas clinical development...$195k - $215k
...Associate Director/Director, Program Manager, CLYM116 About Climb: Climb Bio is a clinical... ...for driving day-to-day delivery against it. Reporting to... ..., risk management, and operating rhythm — ensuring the program... ...Operations, Regulatory, CMC, Nonclinical, Quality, Finance...Contract workWork at officeLocal area- ...unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to... ...combination dosing. The Role:The Associate Director, Training and Contract Operations holds two core accountabilities that... ...Team to ensure the successful delivery of commercial enablement programs...Contract workTemporary workWork at officeLocal areaImmediate startFlexible hoursShift work
$154.4k - $242.55k
...looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, Clinical Operations Program Lead based remotely reporting to the Executive Director, Clinical Operations. At Takeda, we are...Minimum wageFull timeLocal areaRemote work- ...Associate Director Program Management IIThe Associate Director, R&D Program Management (Assoc. Dir.... ...PM) is responsible for directing the operational, planning, and decision-making processes... ...the strategy. The successful delivery of development milestones and goals ties...
$45k
...product development organization operating 11 divisions across 5 research sites... ...Role at Alloy Therapeutics As Associate Director of Antibody Discovery Programs, you will play a key role in... ...timelines, and presenting final deliveries. In parallel, you will provide regular...ApprenticeshipWork at officeImmediate startFlexible hours- ...Overview The Director of Program Management will serve as a strategic and operational leader for priority immunology and inflammation programs, driving assets from mid... ...will partner closely with Clinical, Regulatory, CMC, Nonclinical, Biomarkers, Translational Sciences...Shift work
$165k - $225k
...and more efficiently.The Role:ElevateBio is seeking an Associate Director of Commercial Operations who will be instrumental in managing long-term partnerships... ...and objectives. This role, specifically focused on CMC partnerships in Cell and Advanced Therapies, involves process...Contract work$124k - $186k
Senior Program and Delivery ManagerProduct Operations — Hybrid, USMimecast's Product and R&D organization is scaling fast, and we're looking for a senior partner to bring structure, clarity, and momentum to how we plan, prioritize, and deliver. You'll own the roadmap planning...Full timeLocal area- Job DetailExperience Level Associate DirectorDegree Type Master of... ...Lead impactful statistical programming initiatives in a hybrid work... ...advancements.Job DescriptionAssociate Director of Statistical Programming... ...and align expectations.Operate in a hybrid work environment...Work at officeRemote work
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