- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Site Quality Head, Goa...partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure ... distributed in accordance to cGMP requirements and registered specifications. Most senior professional and independent decision maker authority on product quality… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible for managing major ... defined deliverables and milestones. The program manager is to kick-off project /transfer teams, remove barriers to success, realize opportunities, mitigate risks and… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Director , CMC provides leadership for the Chemistry, Manufacturing and Controls ( CMC ) function for Xeris' commercial and clinical/late-stage ... on CMC matters (eg, Quality, Commercial, Regulatory Affairs, etc.). Ensures the CMC function is adequately represented on Project Teams. + Provides input on… more
- Astellas Pharma (Northbrook, IL)
- …work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... regulatory frameworks and global CMC strategy. This role will lead the development and...global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will… more
- BeOne Medicines (San Mateo, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development...product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Overview:** We are seeking a Senior Director , ADC Process Development, to lead and expand our growing team of ... lead a multidisciplinary team of scientists and engineers, managing resources to meet project and program objectives. + Develop and implement short- and long-term … more
- Takeda Pharmaceuticals (Boston, MA)
- …& Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering ... a product-driven agile culture to support delivery excellence + Collaborate with senior leaders across PharmSci, Research and RDDT including Business Partners, Tech… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** ... operating within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a… more
- ThermoFisher Scientific (Greenville, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher ... and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in...of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + Advanced understanding of medical terminology,… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader - Oncology, Solid Tumors in our Cambridge office. ... into issues and develops contingency plans; communicates timely and proactively project -related issues to senior executive management and manages issues… more
- ThermoFisher Scientific (Greenville, NC)
- … team gaining cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Oversight Respiratory ... depend on - now and in the future. Our Project Delivery colleagues within our PPD(R) clinical research services...and/or programs. Maintains strategic relationships and serves as a senior leadership contact for clients. Provides input to business… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Site Quality Head, Goa...partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure ... in accordance to cGMP requirements and registered specifications. + Most senior professional and independent decision maker authority on product quality and… more
- Sumitomo Pharma (Lincoln, NE)
- …dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part ... (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as… more
- Lilly (Indianapolis, IN)
- …novel technologies, innovative business relationships, and world class systems. The Senior Director , Strategic Alliances position seeks a collaborative, ... who will define and lead activities with external synthetic CMC collaborations. This role will require significant CMC...supply of material for toxicology and clinical trials. The Senior Director role will be critical to… more
- M&T Bank (Buffalo, NY)
- …including interest rate risk, market risk, and liquidity risk. + Represent IRM on senior committees ( CMC , Executive ALCO, MRC) and provide updates to Governance ... development. **Scope of Responsibilities** + **Team Leadership:** Directly manage 5-7 senior professionals; oversee a broader team of 100+ individuals. + **Strategic… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... AbbVie's customers, markets, business operations and emerging issues. Oversees project -related education of investigators, study site personnel and AbbVie study… more
- Organon & Co. (Jersey City, NJ)
- …regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development are critical to the ... future business needs. + Management and oversight of Non-Clinical Development (NCD) project representatives on asset development teams (ADTs) to support the R&D… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Job Title: Director , Program Management Proposed Job Title: Director , Program Management ... and risk management strategies. *Ensure effective communication within team and to Senior Leader stakeholders. *Lead team discussions to resolve issues and ensure… more
- University of Southern California (Los Angeles, CA)
- …gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all aspects of ... including manufacturing and process development activities, in order to ensure that project deliverables meet schedule, cost, scope, quality, and safety and ensuring… more
