CMC Strategy & Operations Executive Director
Flagship Pioneering
Flagship Pioneering in Boston seeks an Executive Director, CMC to lead CMC functions including Drug Substance Development and Regulatory CMC. The role requires a proven track record of driving CMC strategy across multiple programs, managing budget and risk, and ensuring compliance with regulatory expectations. Ideal candidates hold a PhD in a relevant field with over 15 years of CMC experience and a robust understanding of AI/ML processes. The position offers competitive salary and comprehensive benefits. #J-18808-Ljbffr Flagship Pioneering
$238k - $374k
...Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...your career? Join us as Executive Director, Global Regulatory... ...compliant global CMC regulatory strategies and submissions for small... ...think strategically and operate with increasing...SuggestedMinimum wageTemporary workLocal areaRemote work$238k - $374k
...therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...innovative and robust regulatory strategies for medical devices and drug-device... ...to improve regulatory strategy, operational excellence, and quality systems...SuggestedMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide- Kura Oncology, Inc. seeks an Executive Director, Clinical Business Operations to drive operational strategy, governance, and performance across Clinical Operations. This leadership role partners with executive teams to deliver scalable operating models and data‑driven...Suggested
$235k - $335k
...an impact:Kymera is seeking a Senior/Executive Director, AI Strategy & Applications to serve as the company... ..., Clinical Development, Regulatory/CMC, and G&A to turn scientific and business... ..., AEO/GEO familiarity, and comfort operating in a high-autonomy, fast-moving environmentEqual...Suggested$246k - $332k
Overview Department: 106800 Technical Operations Location: San Diego, USA - Remote Be... ...Position Summary Travere is seeking an Executive Director, CMC Diligence to lead the CMC assessments... ...risks and practical mitigation strategies across asset CMC development, manufacturing...SuggestedTemporary workRemote workShift work- ...Kernal Bio is seeking a highly experienced Vice President of Chemistry, Manufacturing, and Controls (CMC) to lead the development and manufacturing of its mRNA 2.0 platform for therapeutic applications. This leader will build and guide the team responsible for manufacturing...
- Moderna Therapeutics is seeking a Director for CMC Digital Operations and Strategic Portfolio Management to own a defined portfolio of digital initiatives. You will translate priorities into 1-2 year roadmaps, drive governance rhythms, and ensure resourcing and measurement...
$210k - $320k
...a wide range of therapeutic editing strategies that Beam is using to advance a diversified... ...a highly talented and motivated Sr. Director / Director of CMC, to lead our advancing portfolio of... ...in the strategic design and execution of Extractables and Leachables (E&L)...Full time$228k - $313.5k
Position Summary We are seeking an Executive Director, CMC (Chemistry, Manufacturing & Controls) with... ...record of driving portfolio-level CMC strategy and execution across multiple emerging... .... This senior leadership role operates at the intersection of science, strategy...- Kymera Therapeutics seeks a Senior/Executive Director of AI Strategy & Applications to become the first dedicated AI leader. Reporting to the VP of IT... ...partnering with Research, Clinical Development, Regulatory/CMC, and G&A to turn scientific and business challenges into...
$130k - $150k
...7, Shields created the Strategic Operations team to work directly with Executive Leadership team on cross functional... ...business priorities & corporate strategies Assist in facilitating effective... ...in formal Management or Board of Director settings, preferably in...Local area- Etiome in Cambridge, MA, is seeking a Senior Director of Corporate Strategy and Operations to partner with the CEO, translating company priorities into clear operating plans and driving cross-functional execution in a fast-moving biotech environment. The role emphasizes...
- ...seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting... ...strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and...
- ...Tech Services team in Boston. You will partner with the leadership to drive vision, strategy, and high-level operations, shaping the future of our organization. With 5+ years in executive leadership, you\'ll translate ambiguous problems into clear plans, influence cross-...Permanent employment
$224.9k - $404.6k
...Norwood MA site and will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency... ...applications. This position will be required to oversee the product strategy for all the products in their portfolio and lead and support all...Permanent employmentFull timeWork at officeWork from home$144k - $176k
...project schedules, budgets, and execution plans across teams. Budget &... ...accruals against approved CMC Ops budgets and interface with... ...risks, implement mitigation strategies and contingency planning to keep... ...project delivery, team operational efficiency and performance. Contributes...Full timeWork at office- Etiome, Inc. in Cambridge, MA, seeks a Senior Director of Corporate Strategy and Operations to partner with the CEO, turning priorities into operating plans and driving cross-functional execution across the organization and with Flagship. Immediate focus on financing, out...Immediate start
- ...Chemistry, Manufacturing, and Controls (CMC) About Kernal Biologics, Inc. Kernal... ...scale the CMC organization, defining the strategy for mRNA drug substance and targeted LNP... ...assessment, and release testing. Define and execute the CMC regulatory strategy, including...Contract workFlexible hours
$167k - $300.7k
The RoleReporting to the Executive Director of Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio Management will... ...role sits at the intersection of digital strategy, CMC innovation, and enterprise execution...Permanent employmentFull timeWork at officeWork from homeShift work$290k - $323k
...Company on LinkedIn and X. Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through product... ...identify regulatory risks, opportunities, and mitigation strategies in alignment with objectives, and communicate to management, as...Temporary workFor contractorsFlexible hours- ...Executive Director, Business Operations About the Company Premier academic medical center Industry Hospital & Health Care Type Non... ...to philanthropic revenue and transformational giving strategies. The position requires a high level of autonomy and authority...
$238k - $374k
...knowledge.Job DescriptionObjective / Purpose: The Executive Director, Head of Pharmacovigilance Operations Oversight provides strategic leadership and oversight... ...as the primary business leader for PV operational strategy, vendor governance, inspection readiness, and continuous...Minimum wageTemporary workLocal area$293k - $358k
Remix Therapeutics, based in Watertown, Massachusetts, is looking for a Vice President, Technical Operations to lead the CMC strategy and manage a high-performing team. This pivotal role involves cultivating strategic partnerships, ensuring compliance, and driving operational...$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica... ...teams, influencing senior stakeholders, and operating effectively in complex matrix environments. Ability to...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$267.91k - $401.87k
...collaboration with AstraZeneca’s Therapeutic Area Units. The Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC), is a... ...approach and ability to interact and build trust Operational effectiveness, highly organized process with follow...Full timeTemporary workWork at officeFlexible hours3 days per week$238k - $374k
...incubate the future AI-powered operating models for large molecule... ...internal or externalized wet lab execution, and a direct line to... ...articulate, and evolve the program strategy for antibody, bispecific, fusion... ...on scientific, clinical, CMC, and commercial considerations...Minimum wageTemporary workLocal areaRemote work- ...Chief of Staff, Strategy and Operations About the Company Fast-growing D2C digital marketplace Industry Retail Type Privately... ...in optimizing the time, focus, decision-making, and execution of the Senior Leadership Team. The Chief of Staff will be a...Remote work
$257.5k - $326.17k
...appropriately. This team uses data-driven insights, market access strategies, and a patient-centric approach to improve awareness,... ...outcomes for people with serious retinal diseases.The Executive Director, Marketing Operations & Analysis will architect and lead the operational...$248.5k
...REQ-10076235 LI-#hybrid The Novartis Strategy & Growth, Therapeutic Area Strategy... ...Oncology & Hematology is seeking a new Executive Director, Therapeutic Area Strategy who will support... ..., Influencing Skills, Leadership, Operations (Inactive), Pipeline (Software) (Inactive...Temporary workLocal area
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