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Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. The Senior Director, Clinical Pharmacology provides clinical pharmacology leadership across development programs, directing PK/PD strategy, modeling and simulation, and dose-selection activities to inform clinical trial design and regulatory submissions.

YEAR

Beeline Medicines

Senior Director, Clinical Pharmacology

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Develops and executes plans to reduce non-value-added costs, increase revenue, and delight customers by delivering products on time with high factory and supplier yields and decreasing product field failure rates. The role manages all aspects related to operations of a manufacturing unit including the full scope of Health, Safety & Environment, Production, Engineering, Project Management and Production Scheduling.

Hitachi Ltd

Factory Director Senior Leader - Greenfield site

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Reporting to the Executive Director, Regulatory CMC, you will lead Regulatory CMC initiatives, develop and execute global CMC regulatory strategies, partner with internal and external stakeholders, and oversee CMC regulatory submissions across our portfolio.

Centessa Pharmaceuticals, LLC

Senior Director, Regulatory CMC

Responsible for the planning, development, authoring, review, and finalization of clinical and regulatory documents, including clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), regulatory briefing documents, clinical summaries and overviews, responses to health authority questions, and other documents supporting global regulatory submissions. · Provides strategic medical writing leadership and develops document strategies in collaboration with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance/Safety, and other cross-functional stakeholders.

AVEO Oncology

Senior Director, Medical Writing

Brightmove

The Associate Director, Quality Operations will act as the primary quality liaison for CMOs, CDMOs, testing laboratories, distributors, and logistics partners and support batch certification by Viridian's contracted Qualified Person (QP). Reporting to the Director, Quality Operations, the Associate Director, Quality Operations will lead quality oversight of Viridian's external manufacturing and supply network supporting EU and international operations.

Viridian Therapeutics Inc

Associate Director, Quality Operations

Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung. Position Overview: The Senior Manager/Associate Director, Field Analytics and Insights, is a key member of the Commercialization Analytics and Operations team at PharmaEssentia USA and reports to the Senior Director, Commercialization Operations.

PharmaEssentia U.S.A.

Senior Manager/Associate Director, Field Analytics and Insights

Provides scientific and organizational leadership in model-informed drug development, including PBPK/PBBM, mechanistic oral absorption, food-effect prediction, relative bioavailability, exposure prediction, in vitro-in vivo correlation (IVIVC), and in vitro-in vivo relationship (IVIVR) development. Demonstrated expertise in developing, applying, interpreting, and evaluating mechanistic models to predict oral drug product performance and clinical pharmacokinetics, including scenarios involving poorly soluble compounds, modified-release drug products, food effects, and formulation changes.

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.

Takeda Pharmaceutical Co Ltd

Director, Head of Biopharmaceutics Predictive Modeling - Oral Drug Product

GENERAL SUMMARY: The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the application of statistical sciences across the product lifecycle, including process development, analytical development, manufacturing, process validation, continued process verification (CPV), stability, quality control, and regulatory submissions. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.

Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.  Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For six years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com

Vertex Pharmaceuticals Inc

CMC Statistics Director

Desirable: Demonstrated curiosity and working knowledge of artificial intelligence, digital health, real-world evidence, data analytics, device innovation, and other technology-enabled advances that can improve medical decision-making, education, and patient outcomes. Support design and execution of designated evidence generation led by Medical Affairs, including Phase IIIb/IV studies, disease registries, observational studies, and noninterventional research, in collaboration with Therapeutic Area Unit representatives and Global Clinical Operations.

Insurance Professional Jobs in Fayetteville, AR

Senior Director, Clinical Pharmacology Beeline Medicines

Factory Director Senior Leader - Greenfield site Hitachi Ltd

Senior Director, Regulatory CMC Centessa Pharmaceuticals, LLC

Senior Director, Medical Writing AVEO Oncology

Associate Director, Quality Operations Viridian Therapeutics Inc

Senior Manager/Associate Director, Field Analytics and Insights PharmaEssentia U.S.A.

Director, Head of Biopharmaceutics Predictive Modeling - Oral Drug Product Takeda Pharmaceutical Co Ltd

CMC Statistics Director Vertex Pharmaceuticals Inc

Global Medical Affairs Lead, PDT Immunology (Director) Takeda Pharmaceutical Co Ltd

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