Director, PK Sciences Neuroscience Therapeutic Area

Job Description Summary

Job Description

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.

Essential Requirements:

• Ph.D. or Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related biologic background.
• A minimum of 10 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma) including 5 plus years of experience in a lead role overseeing DMPK/Clinical Pharmacology project strategy, either in discovery or clinical 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.
• Demonstrated success in working in a cross-functional, matrixed, project-team environment.

The salary for this position is expected to range between $185,500 and $344,500 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO 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 and 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 us.reasonableaccommodations@novartis.com 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.

Salary Range

Skills Desired