Associate Director, PK Sciences Neuroscience Therapeutic Area
Novartis - Cambridge
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Overview
Associate Director, PK Sciences Neuroscience Therapeutic Area
Join to apply for the Associate Director, PK Sciences Neuroscience Therapeutic Area role at Novartis
Associate Director, PK Sciences Neuroscience Therapeutic Area
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Join to apply for the Associate Director, PK Sciences Neuroscience Therapeutic Area role at Novartis
Summary
This position will be on-site in Cambridge, MA or East Hanover, NJ and will not have the ability to be located remotely.
Summary
This position will be on-site in Cambridge, MA or East Hanover, NJ and will not have the ability to be located remotely.
In the Associate Director in PK Sciences you will provide ADME /PK/PKPD project support to the Neuroscience Therapeutic Area contributing to projects from Discovery to IND filing and First-in-Human studies and beyond. In this unique role you will collaborate and partner with PK Sciences functions including in vitro and in vivo ADME, biotransformation, bioanalytics and modeling & simulation and represent the PK Sciences organization within project teams.
About The Role
Key Responsibilities:
- Support teams in developing the strategy for, and coordinate the implementation of, the characterization and selection of lead compounds and drug candidates with favorable PK/ADME properties, elucidate PK/PD relationships driving efficacy/safety and contribute to human PK prediction and dose and regimen selection.
- Provide matrixed leadership across the organization to align and influence across the cross-functional team to identify and mitigate key project issues related to the pharmacokinetic sciences (PKS) discipline (PK, PK/PD, metabolism and clinical pharmacology).
- Proactively contribute to developing drug candidates across the Research Development and Commercial continuum, providing expert pharmacokinetic / drug metabolism and clinical pharmacology input.
- Be responsible for the PK, PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs/NDAs/BLAs within agreed timelines and which meet regulatory requirements as well as prepare appropriate responses to Health Authority questions (globally).
- Oversee or perform PK and PK/PD analyses using a variety of tools and approaches and integrate, interpret and report data to project teams and other customers. Our organization further offers the opportunity to seamlessly gain exposure to different stages of development, different drug modalities and cross-train in multiple indications.
- Ph.D. or Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related biologic background.
- A minimum of 6 plus years in drug discovery or development function including 2 plus years of experience in a lead role overseeing ADME/DMPK or clinical pharmacology strategy of compound development.
- Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.
- Proficient in the application of PK and PK/PD analysis with working knowledge of software such as WINNONLIN/Phoenix
- Hands-on project experience with compounds of various modalities including low molecular weight and biologics drug discovery and development.
- Proven record as leader with good negotiation, organizational and project management skills.
- Strong coaching and mentoring skills desired.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to (email protected) or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Seniority level
Seniority level
Mid-Senior level
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Full-time
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Research, Analyst, and Information TechnologyIndustries
Pharmaceutical Manufacturing
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