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- New Haven, CT

Overview Our client is seeking a Product Quality Assurance Team Leader who will provide quality oversight of new device and combination clinical products from introduction throughout the product and design control lifecycle. As the product quality expert, the Product Quality Engineer will build the strategy to proactively minimize product quality and design control risks through early detection and mitigation during product development, technology transfer, commercial operations, and product....

- New York, NY

Head of Gene Therapy CMC My client is expanding and looking to bring on a new person to lead CMC for Gene Therapy. The ideal candidate will take on the following tasks:Plan, lead and communicate the CMC related strategies for gene therapy products, including selecting CROs and CMOs.Actively manage CRO/CMOs for process optimization, scalable cGMP manufacture (both Drug Substance and Product) to supply a multi-product portfolio of pre-clinical and clinical gene therapy development....


Pharmaceutical company in need of Director or Senior Director to join the Medical Affairs team. The Medical Director will provide support and expertise in the area of psychiatry either Schizo or Addiction as there are two needs In this newly created and high profile role you will serve as the medical affairs strategic lead for our combination oral schizophrenia treatment that is currently in phase 3 clinical development. The Medical Director is expected to establish key medical strategies for....


The Lead, Human Factors Engineering will be serve as a local leader for the Human Factors Engineering Team as it grows. This role will lead human factors work to support the development of devices and combination products for delivery of our wide portfolio of drugs and biologics. This includes leadership in human factors planning, use-related risk management, requirements development and execution of human factors research (user research, formative and summative studies).1. Responsible for....

- Menlo Park, CA

Education and Qualifications - Pharm.D., PhD, or M.D. or equivalent education. - Preferable five to seven years clinical or clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry. - Participated in clinical oncology studies. Overview The Medical Director will collaborate with company management, design, plan and develop clinical evaluation research studies in hematology oncology. He / She will prepare, author and maintain....


Device Development Leader is high impact position for leading development of product device strategy, including technology/platform choice, partner/vendor selection, clinical strategy, regulatory strategy. Requires talented leader with proven expertise in overseeing cross-functional global team activities and to be knowledgeable about overall device development activities. As leader of device development subteam, accountable for device program execution ensuring the translation of product....


The primary objective of the Associate Director, Employee Communications is to partner with the Talent Management leader and team, Human Resources team and managers/leaders across the organization to bring company’s mission and values to life for employees to help drive results, increase enterprise value and assist in attracting & retaining talent. The position will play a role in developing and delivering an employee communication strategy for the global organization. This role will....


Reporting the US Head of Oncology Medical Affairs this Solid Tumor Lead will be accountable for the development and execution of the US Solid Tumor medical affairs strategy. Through cross-functional leadership and deep understanding of the treatment landscape, the Platform Lead will provide oversight and strategic direction to a team of US Medical Leads in development and execution of US medical plans including external engagement, communication and evidence generation strategies and....


Act as recipe lead on DeltaV/Syncade driven fully integrated facility startup, reporting into global Execution Systems organization. Create DeltaV and Syncade design and recipe standards for project that will be used as global standards. Requires extensive experience and strong knowledge of DeltaV and ISA-S88 standards. Strong communication and interpersonal skills. Responsible for the technical setup and structure of the DCS system (DeltaV) and MES system (Syncade) to enable the Start-up,....


The Senior Manager Clinical Operations is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of


Job Category: Research & Development The Senior Clinical Program Leader I3 (Inflammation, Immunology and/or Infectious Disease) is accountable for the operational strategy, planning and execution of the clinical development portfolio up to LIP for the designated Discovery and Translational Area (DTA).You provide the primary interface between the I3 DTA and pRED’s the Clinical Program Execution (CPEX) function in Clinical Operations, oversight for program and study management, line....

- Palo Alto, CA

The Director is primarily accountable for nonclinical toxicology, working in collaboration with nonclinical pharmacology and pharmacokinetic scientists to drive the overall global nonclinical regulatory submission strategy and coordination for multiple company portfolio products, from research to registration and beyond. The individual has experience in evaluating and responding to inquiries from regulatory authorities addressing global nonclinical development issues in support of IND and....


Pharmaceutical company seeking a Quality Control Chemistry Associate I or II for a position based at their Cambridge, MA site initially with a planned move to Norwood, MA in the May/June timeframe. The individual in this role will perform routine testing of raw materials and samples for mRNA products (in process, release and stability) manufactured at the Norwood, MA facility. Also, this individual may support special projects as assigned. He/she will participate in troubleshooting assays and....

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