Job Description Summary

#L1-Hybrid
About the role:
This position will be on-site with preference for Cambridge, MA and will not have the ability to be located remotely.
In the role of Associate Director in PKS you will provide ADME /PK/PKPD project support in the Cardiovascular and Metabolic Therapeutic Area by contributing to the transition of drug projects from discovery to First-in-Human studies and further clinical development. In this unique role you will collaborate and partner with PKS functions including in vitro and in vivo ADME, biotransformation, bioanalytics and modeling & simulation (M&S) and represent the PKS organization within project teams.

Job Description

Key responsibilities:

- Support teams in developing the strategy for, and coordinate the implementation of, the characterization of drug candidates with favorable PK/ADME properties, elucidating 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 PKS discipline (e.g., PK, PK/PD, metabolism and clinical pharmacology).
- Proactively contribute to develop candidate drug products by providing expert pharmacokinetic / drug metabolism / biopharmaceutics and clinical pharmacology input and plans.
- 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 and NDAs 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.

Novartis EVP Manifesto.mp4

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 four to six plus years in early/late drug development including 2 plus years of experience in a lead role overseeing ADME/DMPK strategy of drug development, clinical protocol and report writing, clinical pharmacology plans, modeling strategies, Health Authority interactions.
* 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 low molecular weight and biologics is required with oligonucleotide experience optional in drug development.
* Proven record as leader with good negotiation, organizational and project management skills.
* Strong coaching and mentoring skills desired.

Benefits and rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $151,200 - $226,800/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$151,200.00 - $226,800.00

Skills Desired

Chemistry, Clinical Pharmacology, Clinical Research, Clinical Study Reports, Clinical Trials, Data Entry, Drug Discovery, Due Diligence, Electronic Components, Gene Therapy, Lifesciences, Medical Research, Microsoft Office, Modeling And Simulation, Patient Care, Physics, Project Management, Translational Medicine