- Danforth Advisors (Boston, MA)
- …seeking an experienced Managing Director with expertise in selling clinical and regulatory consulting services to life sciences companies. This role will ... of finance and accounting, strategic communications, human resources, risk management, clinical and regulatory , and commercial readiness and launch. Founded… more
- UNC Health Care (Chapel Hill, NC)
- …regulatory requirements, scientific evidence and current best practice analysis. Collaborates with Director in managing regulatory surveys and audits, and ... delivery state of art, safe, efficient, quality care consistent with organizational and regulatory standards. Reports to the Director of Transplant Services. +… more
- J&J Family of Companies (Columbus, OH)
- …delivering relevant submission documents is required. + Experience leading and managing Regulatory Medical Writing submissions (major global marketing ... Director , Regulatory Medical Writing (1 of... Director , Regulatory Medical Writing (1 of 4) - 2406211847W...and translating the strategy into integrated plans for submission clinical components. This includes partnering with the team to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical ...and submission. + Minimum of 5 years of experience managing direct reports or leading team members. + Proven… more
- Ascendis Pharma (Palo Alto, CA)
- …and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more
- J&J Family of Companies (San Diego County, CA)
- Director , Clinical Pharmacology & Pharmacometrics (CPP) - 2406217110W **Description** Johnson & Johnson is recruiting for a ** Director , Clinical ... & Johnson, we all belong. The Therapeutic Area (TA) Clinical Pharmacology Director role within Clinical...of a compound including innovative ways and leads the regulatory strategy for clinical pharmacology. As CPP… more
- BeiGene (Emeryville, CA)
- …with INDs, NDAs/BLAs, lifecycle management, interactions with US FDA, leading and managing regulatory teams, developing and implementing regulatory ... on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical...and plan holistically in order to develop a NA regulatory position consistent with business needs. Managing … more
- BeiGene (San Mateo, CA)
- …with INDs, NDAs/BLAs, lifecycle management, interactions with US FDA, leading and managing regulatory teams, developing and implementing regulatory ... The Executive Director , Solid Tumor North America Lead will be...on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical… more
- Charles River Laboratories (CA)
- …that you can feel passionate about. **Job Summary** We are seeking anexperienced ** Director of Regulatory Services & Compliance** to join our **Insourcing ... San Diego, CA, or San Francisco, CA.** As the ** Director of Regulatory Services & Compliance** ,...required. At least three (3) years of experience in managing laboratory animal program compliance. + Licensure to practice… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Executive Director , Clinical Quality Assurance is a key leader on the R&D ... process, and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards. The Executive Director will work… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the ... with other functional areas such as commercial, regulatory , pharmacovigilance, CMC, and pre- clinical development in this regard. The Director will be a key… more
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions + Serve ... plans to management and other internal stakeholders + Perform regulatory review of all clinical and nonclinical...regulatory landscapes to maintain current knowledge + Effectively managing timelines while working in a fast-paced and dynamic… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …(ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director , Clinical Development will provide ... such as commercial, regulatory , pharmacovigilance, CMC, early clinical and pre- clinical development in this regard. The Director will be a key… more
- Amgen (Washington, DC)
- …patients worldwide. It's time for a career you can be proud of. **Associate Director Global Clinical Program Management, Obesity - US, Remote** **Live** **What ... (GDO). Responsibilities: + Line Management of Global Trial Managers (GTM)s + Supports Clinical Program Operations (CPO) Director /Snr Director in the… more
- Danaher Corporation (Chicago, IL)
- …Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be ... + Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial...required, with a minimum of 3 years in a managing a team. + Experience leading regulatory … more
- Martin's Point Health Care (Portland, ME)
- …as a "Great Place to Work" since 2015. Position Summary The Senior Director Clinical Programs provides oversight and coordination of care management and ... and will work closely with VP of Health Plan Clinical Program and Director of Health Management...utilization management and prior authorization. + Experience developing and managing health plan program strategy, design, redesign, clinical… more
- AbbVie (Branchburg, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Clinical Development will have global or regional responsibilities ... Program Lead and Clinical Science Lead and Clinical Scientist. The Associate Director , Clinical... development activities in collaboration with the IEST and Clinical + Trial Team(s) + Managing the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. + Leads ... your future at Takeda. Join us as a Medical Director - GI & Inflammation- Rheumatology, in our Cambridge, MA...clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions.… more
- Merck (Boston, MA)
- …monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating pre- clinical ... **Job Description** The **Senior Clinical Director (Sr. Principal Scientist)** has... trials (design, operational plans, settings) based on these clinical development strategies + Monitoring and managing … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join our Clinical Development team. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of ... studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment… more