- PSG Global Solutions (Cambridge, MA)
- …across the portfolio. Provides strategic regulatory leadership to project teams in early and late stage clinical development to advise on international ... filing requirements. Leads the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle. This will include orphan designation requests, meeting briefing documents, and… more
- IGM Biosciences, Inc. (Mountain View, CA)
- …reports and collaborate with cross-functional teams to plan and deliver on-time, compliant clinical supply per the clinical development plan.Develop and lead ... About IGM Biosciences, Inc.IGM Biosciences (Nasdaq: IGMS) is a clinical - stage biotechnology company committed to developing and delivering a new class of… more
- Arcellx (Redwood City, CA)
- Who We Are Arcellx isa public, clinical - stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer ... regulatory environment relevant for cell therapies and regenerative medicine. Support internal clinical and development teams to provide direction on global… more
- Corcept Therapeutics (Menlo Park, CA)
- …batch release. Preferred Skills, Qualifications and Technical Proficiencies: Expertise in late stage process development , process validation, commercial ... produce solid oral dosage Drug Product in support of late phase clinical programs and commercial supply....of Experiments, Proven Acceptable Range studies, and application in late stage CMC development . In-depth… more
- The Higgins Group, Inc. (San Francisco, CA)
- REVOLUTION MEDICINES a clinical stage biotech company dedicated to discovering and developing new drugs that translate frontier cancer targets through ... be accountable for analytical development and operations in support of clinical development and commercialization of the RevMed pipeline compounds. The… more
- Resilience (Boston, MA)
- …and Analytical Development , Drug Substance and Drug Product offerings from pre- clinical to late phase / commercial supply across five modalities ... information, please visit www.resilience.comPosition Summary:The Director, Sales & Business Development role is responsible for growing business relationships with… more
- Orca Bio (Menlo Park, CA)
- … development (preclinical, clinical , and commercial).Collaborate with R&D, clinical development , and commercial teams to ensure regulatory alignment with ... breadth of experience across multiple therapeutic areas and disease states, including clinical stage Oncology biologics/cell therapy products.Viewed as an expert… more
- Archer Hires (Santa Monica, CA)
- …of medical affairs activities including launch readiness support and lifecycle management for late stage development in hematology/oncology. This includes ... affairs activities including launch readiness support and lifecycle management for late stage development in hematology/oncology.Provide strategic input… more
- Gilead Sciences (Foster City, CA)
- …products that are benefiting hundreds of thousands of people, a pipeline of late - stage drug candidates, and unmatched patient access programs to ensure ... Affairs, Regulatory CMC, Quality, Global Patient Safety, Program Strategy Teams (PSTs), Development Teams, Clinical , and global affiliates. The candidate will… more
- Pliantrx (San Francisco, CA)
- …and efficient. This person will be responsible for managing regulatory milestones from early- stage research through clinical development to registration and ... or biotechnology environment. At least 5 of those years in late - stage development .Demonstrated understanding of Regulatory and/or drug development… more
- Pliantrx (San Francisco, CA)
- Associate Director, Corporate CommunicationsPliant Therapeutics is a late - stage biopharmaceutical company focused on the discovery and development of novel ... of Pliant Therapeutics, its integrin-based platform, and its portfolio of early to late - stage drug candidates to various audiences.The ideal candidate will be a… more
- BridgeBio Pharma (Palo Alto, CA)
- …portfolio of 20+ drug development programs ranging from preclinical to late - stage development in multiple therapeutic areas including genetic ... are expanding across Europe.The Director, KOL and Community Engagement will support the development of a late - stage commercial asset, Acoramidis, for… more
- Dennis Partners (Boston, MA)
- …GMP, GLP and GCP compliance strategies and provide advice and support for all clinical development programs.In close partnership with the Head of QA, as needed, ... This clinical - stage biotech company is developing innovative...all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement… more
- ACIP (MA)
- …including formal interactions with regulatory agencies Experience leading regulatory aspects of late - stage drug development through to market Demonstrated ... Mark in EU Provide strategic regulatory leadership, guidance, and training for all clinical development projects to staff, both direct and in-direct, and… more
- Exelixis, Inc. (Alameda, CA)
- …Medical Affairs is favorable, but not required.Experience working on early and late - stage projects favorable, but not required.Experience working with academic ... Sr. Medical Affairs Medical DirectorSUMMARY/JOB PURPOSE:Support the early- stage pipeline by working across the Medical Affairs sub-functions, including the Medical… more
- Exelixis (Alameda, CA)
- …of Medical Affairs is favorable, but not requiredExperience working on early and late stage projects favorable, but not requiredExperience working with academic ... SUMMARY/JOB PURPOSE:Support the early- stage pipeline by working across the Medical Affairs sub-functions, including the Medical Communications, Medical Information,… more
- Nova Anchora (Boston, MA)
- …our recombinant protein therapy through its process, analytical and formulation development stages and subsequent successful clinical manufacturing. This ... clinical material manufacture. Develop a roadmap for further development and scale up to support later clinical...Significant growth potential as the company advances into initial clinical and subsequently late phase and commercial… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …diverse portfolio of marketed medicines and novel product candidates, from early- to late - stage development , in neuroscience and oncology. We actively ... such as medical congress staffing, advisory boards, and sales training initiatives. Clinical Development and Research Management:Act as primary liaison to… more
- Rezolute (Redwood City, CA)
- …multiple functional areas) essential.Prior experience in managing cross-functional teams through late - stage clinical and regulatory projects and related ... Rezolute is a clinical - stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.Rezolute has initiated a… more
- Jazz Pharmaceuticals (Boston, MA)
- …diverse portfolio of marketed medicines and novel product candidates, from early- to late - stage development , in neuroscience and oncology. We actively ... activities aligned with the Medical Plan including advisory boards, speaker development , and clinical trials.Responsible for maintaining Company standards and… more
