- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development team (DT). ... + Serve as team lead or co- lead of marketing application submission...+ Ensure global development plans will meet global regulatory requirements by soliciting and integrating… more
- Bristol Myers Squibb (Princeton, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development...to work successfully in a matrix environment and to lead teams successfully toward drug approvals Other Qualifications: +… more
- Amgen (Washington, DC)
- …for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology ** **Live** **What you will do** Let's do ... Regulatory Affairs Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory ...you will lead one or more the Global Regulatory Teams (GRT) in the … more
- Pfizer (San Diego County, CA)
- … regulatory requirements of different sites and countries. + Ability to lead cross-line global initiatives or root cause analysis for quality related ... **ROLE SUMMARY:** + Lead as a player/coach the group of Asset...oversight of GCP performance and quality systems within the oncology portfolio. + Responsible for ensuring Level 1 GCP… more
- Bristol Myers Squibb (Madison, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead Pediatric Hematology, Oncology and Cell Therapy sits ... within Clinical Development, which is a global organization dedicated to the effective design and execution...oncology and cell therapy . The Clinical Development Lead (Pediatrics) is part of the Pediatrics Center of… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …and ensures brand resonates with current and potential customers. This candidate will lead Digital Marketing for the Oncology brand across customers. Primary ... marketplace and competitive benchmarking to inform strategies for digital marketing programs + Lead the development of a global strategic media plan across… more
- Pfizer (Cambridge, MA)
- …support Head of Scientific Affairs & Strategic Partnerships and Pfizer Oncology Leadership Team (LT) in providing senior-level scientific, strategic and operational ... the Head of Scientific Affairs & Strategic Partnerships in monitoring Pfizer Oncology 's strategy and performance across a broad spectrum of measures, and assess… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The Director, Global Medical Communications and Content, Oncology will plan and deliver an end-to-end medical channel content strategy across ... + Lead the planning, conceptualization, production, and dissemination of Global & US medical content across internally and externally-facing medical channels,… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Pfizer (Andover, MA)
- …of drugs and expand the application of model-informed drug development (MIDD) approaches within oncology and across our portfolio. You will lead a team of ... needs within the oncology therapeutic area. + Provide guidance to our regulatory MIDD strategy + Contribute to the development or improvement of our tools,… more
- AbbVie (Mettawa, IL)
- …our affiliate locations. *Job title/level may vary by country. The INTERCONTINENTAL Oncology Lead will provide medical/scientific strategic and operational input ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- Merck (Rahway, NJ)
- …Global Marketing for Women's Cancer** for the oncology portfolio. The Global Marketing Director will lead overall strategy development for Women's cancer ... commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …with oncology leadership and cross-functional teams to define, build, lead , and drive strategic processes and portfolio analytics development + Leverage ... Join Gilead and help create possible, together. **Job Description** Clinical Operations Oncology is responsible for the worldwide execution of all Phase 1 through… more
- Gilead Sciences, Inc. (Foster City, CA)
- …We empower our leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster ... expert for safety profile of products in therapeutic areas + Defines global product safety strategy and routinely manages and leads functional and cross-functional… more
- Amgen (Washington, DC)
- …time for a career you can be proud of. ** Global Safety Officer (GSO), Global Safety Medical Director, Oncology , US - Remote** **Live** **What you will do** ... decisions and deliverables for assigned products. You will also lead the Safety Analysis Team (SAT), Global ...safety experience either in the bio/pharmaceutical industry or in regulatory agency. + Expertise in Oncology therapeutic… more
- System One (Basking Ridge, NJ)
- Job Title : Director, Biostatistics ( Oncology Indication Lead ) Full time permanent - Direct with a global pharmaceutical company Location: Remote, US Based ... to NJ quarterly. Prior experience as a Statistician indication lead for an Oncology trial is required....entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This… more
- Astellas Pharma (Northbrook, IL)
- …across pre/post-POC development programs, including execution of multiple cross-therapeutic, global clinical drug development programs. Scope may also include ... normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional). + This may… more
- Amgen (Washington, DC)
- …one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products ... a career you can be proud of. Senior Director Global Safety **Live** **What you will do** Let's do...Accountable for providing strategic oversight, direction for all major regulatory safety responses or strategic deliverables including but not… more
- Pfizer (San Francisco, CA)
- …Proactively identify and mitigate potential risks, escalating for awareness as appropriate. + Lead a team of Global Development Leads, Medical Directors and ... **ROLE SUMMARY:** The Late-Stage Oncology Clinical Development Hematology and Myeloma Therapeutic Area Head is a senior leader in clinical development who oversees… more
- AbbVie (North Chicago, IL)
- …+ Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials + Lead clinical study team ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more