- Parexel (Boston, MA)
- …with expert level industry or regulatory knowledge experience in Clinical Development/ Clinical Trial Design, Clinical Strategy , and expertise in ... it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront of...Clinical Regulatory Leader, Health Authority Medical Review Team Lead , Master/Senior Medical Review Officer who is looking to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and applicable regulatory requirements. + Ensures a robust and risk-based audit strategy and framework for the clinical development programs including program- ... well-informed to make decisions on quality and compliance priorities. Contributes to the Clinical & Safety Quality Council. + Lead and participate in… more
- Oracle (Boston, MA)
- **Job Description** The Oracle Clinical AI Agent team's mission is to deliver an AI platform that serves as the foundation for Oracle's health applications. By ... Our diverse team of innovators is building the future of conversational clinical interfaces-improving the lives of patients and providers worldwide. We work with… more
- Genentech (Boston, MA)
- …deep expertise in cross-therapeutic area data modalities to lead and influence clinical trial data strategy across Roche. We balance the need for ... core function within Product Development Data Sciences (PDD). We lead the industry in speed and efficiency across all...high-performing team that drives continuous improvement. + You align clinical data management strategy and execution for… more
- CenterWell (Boston, MA)
- …a Senior Product Owner - Clinical Referral and Specialty Care to lead strategy and execution for our referral management, payer prior authorization, and ... to ensure interoperability and a seamless end-user experience. + Customer & Clinical Voice: Lead structured Voice of Customer (VoC) activities, synthesizing… more
- Sumitomo Pharma (Boston, MA)
- …of clinical development plan(s) for assigned asset(s) and serve as the Clinical Research Lead for stem cell program within the Ophthalmology therapeutic ... area. **Job Duties and Responsibilities** + Responsible for and lead all activities related to clinical study...team through highly complex decisions + Leads and drives strategy for clinical studies for assigned asset(s)… more
- ConvaTec (Lexington, MA)
- …SOPs, guidelines, and regulations. + Working closely with the Global Head of Clinical Operations, develop study level operational strategy and clinical ... Regulatory and executive leadership as needed External - Vendors, Clinical Site Staff, KOLs / site investigators, Lead... Clinical Site Staff, KOLs / site investigators, Lead PIs, IRBs/ECs **Travel Requirements** This position will require… more
- Pfizer (Cambridge, MA)
- …landscape, leveraging emerging technologies and disruptive trends to inform and evolve Pfizer's clinical strategy in I&I. **Candidate Profile** The Global Head, ... championing innovation across all phases of drug development. + Lead the group of physicians and clinical ...+ Lead the group of physicians and clinical scientists including mentorship, career building and effective staffing… more
- Evident Scientific (Needham, MA)
- …**Key Responsibilities** **Regulatory Affairs (US Focus)** + Act as US regulatory lead for clinical and medical device products, overseeing FDA submissions ... QA. + Liaise with FDA and other authorities during inspections and submissions. ** Clinical Study Program Leadership** + Lead global clinical studies… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the patient and provider prospective. This role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within ... to influence across matrixed internal & external environments. **Job Duties** + Medical Strategy : Provide expert medical and clinical insights to inform the… more