- Mannkind Corporation (Boston, MA)
- …and development processes Experience preparing and overseeing regulatory submissions, including INDs/ Clinical Trial Experience with clinical trials and ... Position: Executive Director/Vice President, Head of Regulatory Affairs Location: Boston, MA Job...has a critical role in our success. Committed to diversity , at MannKind we depend on a rich blend… more
- MannKind Corp (Boston, MA)
- …and development processes.Experience preparing and overseeing regulatory submissions, including INDs/ Clinical Trial .Experience with clinical trials and ... community where each of us has a critical role in our success. Committed to diversity , at MannKind we depend on a rich blend of ideas, backgrounds, and working… more
- Friends (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in ... coverage for PDT products.Provides regulatory expertise and guidance to Clinical , Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders… more
- Helen of Troy (Boston, MA)
- …make an immediate impact on our trusted brands: Revlon, Hot Tools, Bed Head , Drybar, Gold-n-Hot, Curlsmith, Honeywell, PUR, Braun, and Vicks. Together, we build ... needed to make the claims.Work with legal and regulatory on crafting robust clinical testing plans, driving the completion of all support materials to marketing for… more
- Pfizer (Cambridge, MA)
- …relationships with our partners, including patient advocacy organizations. The Head of Clinical Trial Diversity & Patient Engagement is responsible for ... Analytics & Recruitment Solutions (OARS) Leadership Team and leads the Clinical Trial Diversity & Patient Engagement Team. **ROLE RESPONSIBILITIES:** +… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in ... for PDT products. + Provides regulatory expertise and guidance to Clinical , Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for… more
- Bristol Myers Squibb (Cambridge, MA)
- …motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Position Responsibilities** + Accountable for the ... within the asset and/or indication + Responsible for managing clinical trial physician(s); attracting, developing and retaining...with support of CTP, CS, and Statisticians + Other clinical development responsibilities as assigned by Head … more
- Sanofi Group (Cambridge, MA)
- …thought was possible. Ready to get started? **Job Summary** Reporting to the Global Project Head , the CRD leads clinical trial strategy and execution of ... ** Clinical Research Director** **About the Job** We are...Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form. + Reviews the study specific committee… more
- Sanofi Group (Waltham, MA)
- …late stage programs + Write / review regulatory documents such as INDs, CTDs, Clinical Trial Protocols, CSRs, and e-BLA sections + Ensure the development and ... Collaborate with Head of Strategic Alliances and Head of Global Clinical immunology to ensure...to continuously strive for excellence + Model Inclusion and Diversity principles and behaviors in all ways of working… more
- Sanofi Group (Cambridge, MA)
- …for developing the clinical development plan, designing and executing clinical trials, analyzing trial data, interacting with regulatory agencies, and ... internal decision making. CRD will work closely with the Global Project Head , Research Scientist, Clinical Pharmacologist, Biomarker Lead, Safety Medical… more
- AbbVie (Boston, MA)
- …on products or areas of therapeutic interest to AbbVie. + Engage with Clinical Trial Site Investigators and Staff to understand enrollment/screening barriers ... AbbVie to find potential medical solutions. Aiming to support clinical trial enrollment. + Establish and maintain...an individual's time may be spent working in the head office if needed - the remainder of time… more
- Sanofi Group (Cambridge, MA)
- …for all methodological and statistical aspects for safety data analyses around pooled clinical trial data of project(s). Act as statistical consultant within ... head , direct statistical support and provide statistical scientific leadership for clinical trial safety data within a project. Accountable for statistical… more
- J&J Family of Companies (Boston, MA)
- …from published clinical trials to facilitate benchmarking, Go/No-go decisions and staged clinical trial design. The group works with clinical development ... Learn more at https://www.jnj.com. For more than 130 years, diversity , equity & inclusion (DEI) has been a part...development teams through utilization of MBMA models to improve clinical trial design and decision making. +… more
- AbbVie (Boston, MA)
- …for bringing people, process, and technology together to generate business value from clinical trial . Our operational model is exemplified through execution and ... the strategy for Oncology in collaboration with CDSO Therapeutic head TA and will also support the growth and...to clinical data management. + Understanding of clinical trial methodologies, data collection processes, and… more
- Sanofi Group (Cambridge, MA)
- …needs including new study ideas and tactics to prioritize the best areas for clinical trial investment. + Collaborate with alliance partners at Regeneron: take a ... part of a paradigm shift. The new Leader will report directly into Head , Global Medical Affairs, **Rhinology and Gastroenterology,** and will be responsible for… more
- Novo Nordisk (Lexington, MA)
- …methodology, and data interpretation + Proficiency in R and NONMEM + Experience working with clinical trial data and clinical drug development + Possesses a ... communication, and reporting of pharmacometrics information throughout all phases of clinical drug development. This will include modeling PK data from ongoing… more
