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Join us as a Director, Toxicology Project Support within our Global Drug Safety Research & Evaluation (DSRE) organization, based in Cambridge, MA. As part of the Global Toxicology Team, work in interdisciplinary teams within and across Global Safety to provide safety support to early discovery and development teams as well as engage in core activities within the Toxicology group.
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The individual will be responsible for TM and clinical biomarker activities to support drug development programs in neurodegeneration and neuropsychiatric indications. Experience in late stage drug development and activities required for and related to clinical trial initiation, maintenance and completion.
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MSc / PhD in a discipline related to pharmaceutical drug discovery and development, e.g., Biochemistry, Chemistry, Pharmacology, Physiology, Cell Biology, Molecular Biology or Genetics. Importantly, will have / build a strong demonstrable knowledge of Lilly's systems and highly professional ways of working, coupled with a good understanding of the drug discovery and development process / high learning agility.
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Director/Sr. Director - Process DevelopmentGreater Boston Area Competitive Compensation + excellent bonus/benefitsDuties and Responsibilities:Lead all process development activities (cell culture/banking/development, fermentation, protein purification, tech transfers)Oversee internal(in-house) and external vendors (domestic & international CDMOs)Work cross-functionally with CMC & Manufacturing leaders such as Analytical, Drug Product, QA/QC, Manufacturing, Supply Chain, etc.
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Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
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Exceptional matrix team leader, ability to interface with leaders across the enterprise and project teams to develop long range plans and budgets for clinical biomarker pathology technologies aligned with company objectives, identify, pilot and establish new pathology related technologies to meet drug development needs in Ph 1, Proof of Mechanism/Concept, and in registrational clinical trials.
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Experience in immuno-oncology drug development is a must. Advanced scientific degree (MD, PhD, DVM, PharmD), with a minimum of 12 years of relevant work experience developing translational medicine strategies, developing and testing hypotheses in the clinic, biomarker identification and development, biomarker data interpretation.
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Provides scientific and strategic expertise to DMPK Project Team Representatives for the development of TA drug candidates. Provides scientific leadership to ensure selection of clinical candidates with optimal drug development characteristics and appropriate characterization and development of these candidates.
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The Principal Scientist of Analytical Development and QC at Foghorn Therapeutics will drive the analytical development and QC functions, ensuring the successful advancement of small molecule candidates from preclinical through NDA for both drug substances and drug products.
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Our offerings will span across our technology platforms, Process and Analytical Development, Drug Substance and Drug Product offerings from pre-clinical to late phase / commercial supply across five modalities (Cell/Gene/Nucleic Acids/Biologics/Vaccines.
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This key leadership role will require an individual to direct and oversee in vitro pharmacology efforts, participating in drug discovery and early development activities. With a highly experienced drug development team and access to the wide ecosystem of Flagship companies, Pioneering Medicines is well positioned to conceive new medicine ideas both internally and in collaboration with strategic partners and advance these assets through to significant value inflection.
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Experience in protein/protein, protein/RNA, RNA/small molecule or protein/small molecule interactions by DSF, ITC, and/or MST and have applied these to small molecule drug discovery preferred. You will be the Biochemistry lead on projects and play a key role in drug discovery.
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Job DescriptionGeneral Summary:Vertex/VCGT (Cell and Gene Therapy) is searching for an experienced Senior Medical Director for a leadership role in managing assets in its hematology development portfolio, specifically including sickle cell disease and beta-thalassemia.
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Oversee the development and execution of product intelligence strategies to support the company’s drug discovery and development efforts. Deep understanding of the oncology market, drug development process, and regulatory environment.
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Develop various models to evaluate risk/benefit and facilitate drug development decisions. Proficiency in Model Informed Drug Development. 5+ years of experience for Associate Director or 8+ years for Director in clinical pharmacology, modeling & simulation, drug metabolism, and/or pharmacokinetics within pharma or biotech.
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drug development jobs Title: director in Watertown, MA
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