- Sanofi Group (Bridgewater, NJ)
- ** Global Clinical Development Strategy Expert - Vaccine** **Location: Waltham, MA** **Work model: Hybrid** **About the Job** We are an innovative ... Sanofi Vaccines R&D. + Have global responsibility and ownership for the Clinical Strategy , the respective Clinical Development Plans (CDP) and study… more
- AbbVie (Branchburg, NJ)
- …be responsible and accountable for the development , implementation, and delivery of the global clinical development strategy for a given project ... solutions. He/she leads the development of the Global Development Strategy , in collaboration...Clinical Team and ensuring alignment with the agreed Global Development Strategy . Once completed,… more
- Merck (Rahway, NJ)
- …The Associate Vice President (AVP)/Section Head, Global Clinical Development , Ophthalmology will focus on driving strategy , development , and ... organization therefore requiring someone who has built and lead clinical development plans from the ground up....to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… 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
- Merck (Rahway, NJ)
- …Are you passionate about serving patients with quality products? Within our Research & Development Division, the Global Clinical Supply (GCS) organization is ... guidelines. GCS operates in close collaboration with Discovery Sciences Clinical Supply (DSCS), Global Development ...but not limited to): + Design and lead the strategy implementation and execution of the culture of compliance… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Clinical Data Strategy & Operations is the best-in-class team within ... agencies regarding assigned clinical trials + Lead clinical study team in the development of... trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse… 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
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. ... effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with leadership across the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …asset teams to enable seamless tumor-specific clinical development and strategy . Responsibilities - Accountable for developing the Global Clinical ... Clinical Science Group Lead in late phase development in the Global Clinical ...and access and commercial business units to ensure unified Global Clinical Science Strategy . In… more
- Bristol Myers Squibb (Summit, NJ)
- …for clinical trials from Phase 1 through Proof-of-Concept by + Articulating clinical development strategy + Analyzing, interpreting, and acting on ... Read more: careers.bms.com/working-with-us . The Early Clinical Development function is part of a global ...across early development clinical lifecycle ** Clinical Development Expertise & Strategy **… 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
- 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: Sep...clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** +… more
- Merck (Rahway, NJ)
- …**Position Description:** **Device Development Associate Principal Scientist - Development Strategy , Design Controls and Risk Management** Our company's ... projects. + Lead the implementation and/or ensure effective execution of the device development strategy , design controls and risk management activities for the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and impact to key stakeholders. He or she will aid in the construction of clinical development plans, clinical protocols, and in submission of certain ... Summary:** The position will define and oversee the translational strategy /plan for oncology therapeutic program/s in global ...data analysis plans, and aid in the construction of clinical development plans, clinical protocols,… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …is comprised of: Product Development , Biologics Operations, Small Molecule Operations, Global Supply Chain, Global Quality, Strategy & Business ... geographic locations. Rotations will include technical leadership, supervisory roles, strategy development , supply chain optimizations, plant manufacturing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...early development plan and contributes to overall development Strategy ; Develops program biomarker strategy… more
- Novo Nordisk (Plainsboro, NJ)
- …(KOLs), vendors, and consultants. Manages 5-8 direct reports. Essential Functions + Oversees development of the market access strategy for all inline and ... your potential? The Position Leads value communication and pricing and contracting strategy for a key Novo Nordisk product category. Ensures alignment between the… more