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📑 Job DescriptionJob DescriptionDescription:Responsible for providing support in Regulatory Operations filing multiple original INDs each year and managing multiple active INDs in Phase 1/2 clinical trials (US, Canada, EU and APAC). He/she will manage day to day regulatory operations to ensure all Kumquat regulatory submissions are on time, complete, ...

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📑 Job DescriptionJob DescriptionSalary: $204,404-$235,000The Director of Clinical Pharmacology will lead the development and implementation of clinical pharmacology strategies for small molecules and biologics within the company's portfolio. They will offer expertise in analyzing pharmacokinetics, absorption, distribution, elimination profiles, dose ...

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📑 Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - will work partly in office and partly remote. Looking for a Regulatory Affairs Specialist with at least 2 years of regulatory experience along with submissions. Will work on IND submissions (publishing and structure of the IND, not ...

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📑 Senior Director, Regulatory Affairs*Bay Area- Hybrid*Meet has partnered with a fantastic Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. You will be coming in to lead their Oncology portfolio and you'll be reporting into the VP of Regula ...

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📑 If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Associate Director, Regulatory Affairs CMC Full Time Mgr & Dir - R&D/Ops Malvern, PA, US 10 days ago Requisition ID: 1072 The Associate Director, Regulatory Affairs CMC will le ...

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📑 Associate Director/Director, Regulatory Affairs (Oncology)Remote - East Coast CandidatesMeet has partnered with a very well-established pharma with roughly 20 approved products and a robust development pipeline. They are looking for an Associate Director or Director of Regulatory Strategy to join their team. This role will be reporting into the VP ...

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📑 LEAD FORMULATION SCIENTIST(Level: Manager or Principal Scientist)Location: San Diego LabWe are a small biotech located in South San Francisco and San Diego. We are bringing multiple programs forward in major ophthalmic indications based upon novel science underlying pro ...

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📑 We are partnered exclusively with an exciting biotech company who are looking to bring on their first hire within their regulatory affairs department. Role can be at Director or Senior Director level.The team are looking for individuals with the following experience:Authoring and submitting an IND (the company is a year away from submitting its fir ...

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📑 Director, CMC Regulatory AffairsDirect Hire Fulltime RoleSalary Range: $208,000 - $235,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing ap ...

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📑 Director, CMC Regulatory AffairsDirect Hire Fulltime RoleSalary Range: $208,000 - $235,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing ap ...

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📑 LEAD FORMULATION SCIENTIST(Level: Manager or Principal Scientist)Location: San Diego LabWe are a small biotech located in South San Francisco and San Diego. We are bringing multiple programs forward in major ophthalmic indications based upon novel science underlying protective biologies in the eye. We are backed by strong funding partners and a gro ...

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📑 About LexeoLexeo Therapeutics is a New York City-based, clinical-stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging e ...

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📑 Principal Scientist/Associate Director Antibody Process DevelopmentWe are seeking a Principal Scientist/Associate Director Antibody Process Development to join the Adcentrx CMC team.Adcentrx Therapeutics is driving ground-breaking efforts in cancer biotherapeutics drug development. The candidate will help to develop novel targeted biotherapeutics t ...

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📑 Clinical Development Leader (Medical Director to Senior Director level)San Francisco (remote/hybrid) **MUST reside on the West Coast or willing to relocate**Full-timeSciPro is working with one of the most exciting names in Oncology. This position holds high visability and will report directly to the CMO.My client is on the verge of going public due ...

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📑 I am partnered with a Small growing biotechnology company in the San Francisco area that is looking for a Pharmacokinetics expert to join their team! In this position you would be given the opportunity to be the first Pharmacokinetics expert and begin to build out the team along the way. My client is looking for an individual that can come in and h ...

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📑 Clinical Development Leader (Medical Director to Senior Director level)San Francisco (remote/hybrid) **MUST reside on the West Coast or willing to relocate**Full-timeSciPro is working with one of the most exciting names in Oncology. This position holds high visability and will report directly to the CMO.My client is on the verge of going public due ...

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📑 Principal Scientist/Associate Director Antibody Process Development We are seeking a Principal Scientist/Associate Director Antibody Process Development to join the Adcentrx CMC team.Adcentrx Therapeutics is driving ground-breaking efforts in cancer biotherapeutics drug development. The candidate will help to develop novel targeted biotherapeutics ...

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📑 Director, Clinical Development - Specialty Medicine page is loaded Director, Clinical Development - Specialty Medicine Apply remote type Hybrid Work Arrangement locations Basking Ridge, NJ time type Full time posted on Posted 3 Days Ago job requisition id R2939 Join a Legacy of Innovation ...

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📑 Associate Director, Global Regulatory Affairs - Early-Development ** Rare Diseases ** PIP's and ODD's** Boston, MAWe have a new RA Associate Director position with a Greater Boston-based Rare Disease Biotech, which is well-funded with a broad portfolio of TA's and indications across a variety of modalities who are led by a talented and highly regar ...

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📑 GeneCoda has been retained to identify and evaluate candidates for a Chief Medical Officer (CMO) to onboard in late Q2 or early Q3 of 2023 and to be located in the Research Triangle Park, NC. Some relocation assistance can be provided for candidates not already located in the region. Learn why the RTP, NC area as a global life sciences leader m ...

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📑 Position DescriptionTr1X is seeking a highly motivated and talented individual who has the desire to excel in a fast-paced biotech environment. As Senior Process Engineer, MSAT, you will report directly into Director of Process Development and Manufacturing in the Technical Operations department and function as the manufacturing process SME to ...

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📑 Job DescriptionJob DescriptionPosition: Process Development ScientistWe are seeking a highly motivated and creative individual to be a part of a cutting-edge cell and gene therapy process and product development team. The successful candidate will be responsible for leading upstream process development/optimization studies to advance our R&PD progr ...

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📑 About LexeoLexeo Therapeutics is a New York City-based, clinical-stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise dev ...

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📑 Director / Senior Director, Nonclinical SafetyNimbus has an outstanding opportunity for an exceptional Director / Senior Director of Nonclinical Safety (Toxicology) to join our rapidly growing team. This role will lead the safety strategy, from discovery through both nonclinical and clinical stages, and direct all phases of early investigative toxi ...

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📑 Requisition Number2229806 Description & Requirements Location: Location: This position can be filled in any of our FORVIS office locations or can be a fully remote work opportunity. Ready to Accelerate Your Career? Join our rapidly expanding advisory team! Our Advisory practice brings our f ...

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📑 Reporting to our Senior Director, Drug Product, Process Development, we are seeking an Associate Director to join our team. This position is predominantly a lab-based role and will be responsible for developing scalable processes for LNP delivery of gene-editing RNA cargos. This position will play a critical role in successfully developing manufact ...

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📑 A clinical-stage biotechnology company based in San Francisco, backed by Third Rock Ventures, is harnessing the power of adipocyte biology and the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company is building a pipeline of therapies that target rare and common cardiometa ...

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📑 A clinical-stage biotechnology company based in San Francisco, backed by Third Rock Ventures, is harnessing the power of adipocyte biology and the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company is building a pipeline of therapies that target rare and common cardiometa ...

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📑 A California-based biopharmaceutical company is looking to add an experienced professional to their CMC Quality Control Department as a Writer / Reviewer. In this role, the CMC Quality Control Writer / Reviewer will be responsible for authoring, drafting. reviewing, and approving the Regulatory QC CMC sections of the company's IND/IMPD and BLA/NDA ...

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📑 ** Assoc Dir RA, Boston ** Working on rare diseases, obesity, liver in early and mid-phase compounds for a smaller and stable company with higher visibility from an exclusive leadership teamDo you want to be autonomous in your work and interact closely with the leadership team, to have higher visibility and more opportunities to grow …… then this c ...

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📑 RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Director/AD, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of rare cancer and solid tumours.The candidate will report directly to the Head of RA, ...

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📑 4 month Contract Research Associate Responsibilities: Design and execution of in vivo pharmacology studies to support programs Identify, develop, and validate in vivo models that build pharmacologic relationships between drug exposure, and pharmacodynamic biomarkers Work collaboratively with other groups to develop and execute ex vivo assays to mon ...

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📑 4 month Contract Research Associate Responsibilities:· Design and execution of in vivo pharmacology studies to support programs· Identify, develop, and validate in vivo models that build pharmacologic relationships between drug exposure, and pharmacodynamic biomarkers· Work collaboratively with other groups to develop and execute ex vivo assays to ...

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📑 Work at ROCKET PHARMA and help cure rare diseases!Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looki ...

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📑 Work at ROCKET PHARMA and help cure rare diseases!Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looki ...

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📑 Do you want to be part of a growing world-class organization focused on bettering our world? Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!AmplifyBio is a newly established, commercially focused preclinical CRO that was created ...

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📑 4 month Contract Research Associate Responsibilities:· Design and execution of in vivo pharmacology studies to support programs· Identify, develop, and validate in vivo models that build pharmacologic relationships between drug exposure, and pharmacodynamic biomarkers· Work collaboratively with other ...

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📑 Remote - Candidates must be located in the United States - Ideally Southern California The Senior Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of regulatory CMC submissions. This position is a hands-on ...

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📑 This is an opportunity to work with an innovative biotechnology company working on the development and manufacturing of small molecules for a diverse portfolio of therapeutic targets. To support the continued growth of the pipeline, we are looking for an experienced Senior/Executive Director of CMC to guide strategy.Responsibilities:Oversee vendors ...

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📑 This is an opportunity to work with an innovative biotechnology company working on the development and manufacturing of small molecules for a diverse portfolio of therapeutic targets. To support the continued growth of the pipeline, we are looking for an experienced Senior/Executive Director of CMC to guide strategy.Responsibilities:Oversee vendors ...

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📑 Chief Administrative Officer, IND IND (Neurodegenerative Dis) Full Time 77087BR Job Summary The Chief Administrative Officer (CAO) oversees all activities related to the administration of the Institute for Neurodegenerative Diseases (IND), including financial, personnel, systems, program and project, and facilities management. The CAO ensure ...

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📑 Chief Administrative Officer, IND IND (Neurodegenerative Dis) Full Time 77087BR Job Summary The Chief Administrative Officer (CAO) oversees all activities related to the administration of the Institute for Neurodegenerative Diseases (IND), including financial, personnel, systems, program and project, and facilities management. The CAO ensur ...

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📑 Company Overview:Biotalent is a pioneering biotech company located in San Diego is seeking a talented Scientist to join their team. Backed by strong funding partners, the company is focused on advancing therapeutic programs in major ophthalmic indications.Position Summary:The selected candidate will play a pivotal role in designing, executing, and ...

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📑 Director, Clinical Development - Immunology*Remote for East Coast Candidates*Meet has partnered with a well-established pharma based on the East Coast! They are looking for a Director of Clinical Development to join their immunology department. This position will be reporting into a Senior MD and will be supporting multiple global clinical programs ...

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📑 Director, Clinical Development - Immunology*Remote for East Coast Candidates*Meet has partnered with a well-established pharma based on the East Coast! They are looking for a Director of Clinical Development to join their immunology department. This position will be reporting into a Senior MD and will be supporting multiple global clinical programs ...

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📑 Associate Director, Regulatory AffairsThis position will serve as the company US Agent and a contact point between the FDA and company sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Senior Regulatory Associates ...

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📑 Associate Director, Regulatory AffairsThis position will serve as the company US Agent and a contact point between the FDA and company sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Senior Regulatory Associates ...

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📑 A small cell therapy company based in San Diego, CA, emerging in the autoimmune sector, is looking to add a key decision-maker to its Quality Control team. This opportunity seeks expertise in raw materials to support their in-house handling of materials, which is commonly outsourced. They filed their first IND for their autoimmune study, entering p ...

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📑 Remote - Candidates must be located in the United States - Ideally Southern California The Senior Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of regulatory CMC submissions. This position is a hands-on ...

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📑 Subject Matter Expert, Retail Business ServicesAbout Amazon.comAmazon.com strives to be Earth's most customer-centric company where people can find and discover virtually anything they want to buy online. By giving customers more of what they want - low prices, vast selection, and convenience - Amazon.com continues to grow and evolve as a world-cla ...

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