- Sanofi Group (Bridgewater, NJ)
- **Director** Global Clinical Development Strategy Expert **Location:** Swiftwater, PA, Cambridge, MA, Orlando, FL or Morristown, NJ site (flexibility ... Sanofi Vaccines R&D. + Have global responsibility and ownership for the Clinical Strategy , the respective Clinical Development Plans (CDP) and study… more
- Merck (Rahway, NJ)
- …the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy , development , and life-cycle ... in the late development of assets within the Metabolism Section of Global Clinical Development + May serve as a senior therapeutic area content expert… more
- Merck (Rahway, NJ)
- …The Associate Vice President (AVP)/Section Head, Global Clinical Development , Respiratory will focus on driving strategy , development , and ... in the late development of assets within the Respiratory Section of Global Clinical Development + May serve as a senior therapeutic area content expert… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Portfolio Management, and Biostatistics & Data Management (DO, PM & BDM) and Global Development (GD). This role collaborates with other GD Strategy ... evolution of the specified organization. This role will support Clinical Trial Management, Global Clinical ...preferred. + Demonstrated depth of understanding of the drug development process, specifically related to clinical trial… more
- Pfizer (New York, NY)
- …and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development . + The Medical Strategy Program Lead will report ... + As a part of the MST within the Global Product Team (GPT), the Medical Strategy ...of the medical plan, working collaboratively with Oncology Early-and-Late Clinical Development , Oncology Medical Affairs, Pfizer US… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology...direction, acting as a key decision-maker and/or arbitrator on global projects. + Interface with clinical and… more
- AbbVie (Jersey City, NJ)
- …abreast of new and/or evolving local regulations, guidelines and policies related to clinical development . If assigned, participates as the DS study owner in ... Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Clinical Data Strategy & Operations is the best-in-class team within… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …tracked and ensure implications are assessed and communicated on timely manner - Clinical Development Life Cycle Management Decision Support: Be the key point ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...launched brands. The role will be responsible for the development and maintenance of Short to Long Term Forecasts… more
- AbbVie (Florham Park, NJ)
- …abreast of new and/or evolving local regulations, guidelines and policies related to clinical development . Coordinates and participates as the DS study owner in ... bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and… more
- Bristol Myers Squibb (Madison, NJ)
- …to develop program strategy and clinical program, commercialization strategy plans, business case development , and understands how access, pricing and ... (eg, TPP, DEX/VAP, CI insights) into the integrated development plan, incl., clinical plans and labeling strategy ; Appreciates translation of clinical … more
- AbbVie (Florham Park, NJ)
- …of translational strategies. *May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, ... *Responsible for understanding the regulatory requirements related to the clinical studies and global drug development...requirements governing clinical trials and experience in development of clinical strategy and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medical history, and medications when needed ** Clinical Development Expertise Strategy :** + In collaboration with the Global Clinical Lead (GCL), ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...from a medical strategy standpoint to the development of clinical sections of study-level documents… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …multiple Clinical Development Plans + Leads or oversees the cross-functional clinical development team + Supports Global Clinical Operations in ... plan and will provide leadership for assigned asset strategy , working closely with other functional areas such as... Global Drug Safety and Pharmacovigilance, SVP Late Clinical Development and the Disease Area Heads,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …multiple Clinical Development Plans + Leads or oversees the cross-functional clinical development team + Supports Global Clinical Operations in ... Director Clinical Development - Oncology Date: Oct...clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** +… more
- Organon & Co. (Jersey City, NJ)
- …will be responsible for contributing and/or devising the early clinical development & translational medicine development strategy supporting ... Good working knowledge of regulatory guidances and requirements pertaining to early clinical development including clinical pharmacology guidelines and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Medical Director, Clinical Development , Oncology will function as clinical leader of a section of a clinical program (eg, an indication, a new ... incumbent will also lead multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions and...aspects and drives execution of the section of the clinical program in partnership with global line… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …MD. Clinical deliverables may include individual protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory ... advisory boards, patient advocacy groups), internal stakeholders (eg, Research, Early Clinical Development , Medical Affairs, Marketing, HE&OR), and internal… more
- Bayer (Whippany, NJ)
- …cross functional teams, US and global ; + Responsible for overall research strategy including development of study design & conduct, identification of data ... clinical protocols, clinical reports, integrated summaries and/or a clinical development plans, economic dossiers and technology assessments) as well as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …fabric of Daiichi Sankyo. Responsibilities - Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC ... disease strategy and the strategic choices for clinical development and data generation - Develop...leading change management initiatives preferred - Prior experience in clinical development , Medical Affairs, or Global… more
- IQVIA (New York, NY)
- …all phases of development from discovery to market. You will oversee preclinical strategy , clinical strategy , regulatory strategy , and commercial ... development strategist to join our team as Therapeutic Strategy VP, Oncology. The ideal candidate will have a...preparation of a gap analysis with a focus on clinical development . In addition to the responsibilities… more