NEW ENGLAND DRUG METABOLISM DISCUSSION GROUP

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PLEASE SEND SUBMISSIONS TO SECRETARY@NEDMDG.ORG

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Principal /Senior Principal Scientist PKS Oncology, Novartis

Careers (myworkdayjobs.com)

Cambridge (USA)
time type
Full time
posted on
Posted 9 Days Ago
job requisition id
REQ-10006554

Job Description Summary

Principal Scientist/Sr. Principal Scientist PK Sciences – Oncology

#LI-Hybrid

About the role:
The position is located in Cambridge, MA and will not have the ability to be located remotely.

About the role:
We are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement DMPK and/or clinical pharmacology strategies to support the pursuit of transformative new medicines from early discovery through late clinical development. Our unique organizational structure enables colleagues to work seamlessly in the discovery and/or clinical space, offering opportunities for development and bench-to-bedside-to-bench translation. Equally, deep expertise in either discovery or clinical areas are valued. The scope of the role potentially includes small molecules, biologics/therapeutic proteins, antibody drug-conjugates, radioligand therapies and/or cell therapies.

 

Job Description

Key responsibilities:

  • Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate.
  • Develop the PK strategy for lead optimization and oversee the execution of nonclinical studies to identify compounds with favorable DMPK properties.
  • Work with teams to elucidate the understanding of PK/PD relationships and develop dosing strategies and predictions.
  • Develop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late development.
  • PK, dosimetry (radiopharmaceuticals), PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections/radiation dosimetry of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions across the globe.

 

This role reports to a PK Sciences (PKS) Oncology group lead/unit head within Translational Medicine (TM) in Biomedical Research. PKS is a global organization of about 300 associates, situated within Translational Medicine (TM), the clinical research arm of Biomedical Research within Novartis. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise-wide organization, working across both Biomedical Research and the Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology. Particularly, in radioligand therapies, Novartis has become the industry leader and is now developing a wide range of targeted radioligand therapies, and precision radioligand imaging agents, targeting multiple tumor types through a phenotypic precision medicine approach.

 

Novartis EVP Manifesto.mp4

 

Essential requirements:

  • Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.
  • A minimum of 2 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma).
  • 4 plus years of experience required to be considered for Senior Principal Scientist level including 2 plus years of experience in a lead role overseeing ADME/DMPK 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.
  • Demonstrated success in working in a cross-functional, matrixed, project-team environment.
  • Strong oral and written communication skills.

 

Desirable requirements:

 

  • Hands-on project experience with drug conjugates and/or radiopharmaceuticals is a plus.

 

******

Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook

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 $130,400 – 195,600/year for Principal Scientist II and  $136,800 – 205,200/year for Principal Scientist II; 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

$130,400.00 – $195,600.00

 

Skills Desired

Chemistry, Clinical Pharmacology, Clinical Research, Drug Discovery, Initiative, Medical Research, Patient Care, Physiology, Quality Control, R&D (Research And Development), Simulation Software, Translational Medicine

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Associate Director, Pharmacokinetic Sciences (PKS), Novartis

Careers (myworkdayjobs.com)

Cambridge (USA)

time type
Full time
posted on
Posted 14 Days Ago
job requisition id
REQ-10005158

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

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Associate Director, M&S PBPK, Novartis
May 23, 2024
USA

About the Role

Hybrid

This position can be based at our East Hanover, NJ or Cambridge, MA campus and will not have the ability to be located remotely.

About the role:

Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS), within TM, collaborates across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.

The Modeling & Simulation group within PK Sciences is looking for an Associate Director, to develop and apply translational physiologically based pharmacokinetic (PBPK) modeling along with data analysis techniques to facilitate drug discovery, development, and translational research across disease areas. The candidate’s core responsibilities will include PBPK modeling to integrate in vitro and in vivo data for drug-drug interaction (DDI) assessments, impact of biopharmaceutics properties on absorption, and pharmacokinetic (PK) predictions in humans as well as in specific populations (e.g. disease, organ impairment, pediatrics). The ultimate goal of this work is to be on the forefront of applying PBPK models to inform the safe administration of our drug candidates in the clinic, to optimize clinical trial designs, and waive clinical trials, ultimately, to get our medicines to patients faster.

Your Key Responsibilities:

• Expert PBPK modeler to provide translational modeling support for global drug discovery and development projects
• Perform translational PBPK analyses to predict clinical drug exposure in specific populations, assess potential for DDI, understand clinical impact of disease on drug exposure, as well as apply biopharmaceutic PBPK modeling to support formulation changes and achieve clinical biowaivers
• Integrate PK/ PD data, ADME and DDI findings
• Ability to interpret and communicate modeling results and potential impact to project teams
• Prepare summary documents for use in regulatory submissions and ability to respond independently to health authority questions

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $166,400 – 249,600/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.

Diversity & Inclusion / EEO

We 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

  • Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
  • Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098

Role Requirements

As an Associate Director in PBPK you will have a deep understanding of ADME/DMPK principals and biopharmaceutics knowledge, experience with industry standard PBPK modeling packages (such as GastroPlus or Simcyp), have experience with regulatory submissions and in successful regulatory interactions, interdisciplinary thinking and great attention to detail. You will work in a dynamic and multidisciplinary environment to build, verify and apply quality translational/biopharmaceutical PBPK models.

Essential Requirements:
• PhD in pharmaceutical sciences or related discipline with experience in ADME/DMPK sciences, biopharmaceutics, and modeling and simulation
• 5+ years in pharmaceutical industry including demonstrated knowledge and experience with PBPK modeling.
• Hands on experience with PBPK modeling tools such as PK-Sim, Simcyp, or GastroPlus is required. In addition, experience with modeling software such as Monolix, R, Phoenix, or Nonmem is desired.
• Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidance
• Broad knowledge of drug discovery and development, e.g., pharmacokinetics, drug delivery, formulation, ADME, DDI, etc.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

.

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? https://www.novartis.com/about/strategy/people-and-culture

Join 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: https://talentnetwork.novartis.com/network

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Sr Principal Scientist/ Assoc Director, Translational Modeling (M&S), Novartis

About the Role

This role is located at our Cambridge, MA site and will not have the ability to be located remotely.

#LI-Hybrid

About the role:

We are seeking an experienced translational modeler eager to accelerate drug discovery & development by facilitating rigorous decision making with modeling & simulation, from target identification to first-in-human studies and beyond. You will work in a multi-disciplinary environment with opportunities to engage in projects that span different therapeutic modalities.

This role reports to a PK Sciences Translational Modeling team lead, in a group situated within Biomedical Research, the research engine of Novartis.

Key responsibilities:

• Act as the Translational M&S representative on programs in oncology, developing and executing modeling strategies, contributing to project team discussions, and guiding therapeutic design and dose selection decisions.

• Build and apply QSP and physiologically based PK (PBPK) models that link drug pharmacology, tissue biodistribution, mechanism(s) of action, and biological outcomes.

• Collaboratively develop integrated modeling platforms that bridge data and knowledge across preclinical species and patients, partnering with discovery project teams as well as the preclinical safety and pharmacometrics groups.

• Contribute to programs across therapeutic modalities and disease indications, as needed. Novartis has a broad portfolio of drug discovery and clinical development projects and you will have opportunities to grow and develop as you apply modeling insights to diverse projects.

• Proactively seek opportunities to increase the impact and awareness of translational modeling through communications with internal and external audiences.

• Contribute to group strategy and serve as an M&S subject area expert across PK Sciences and Biomedical Research initiatives.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $166,400 – $249,600/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.

https://www.linkedin.com/posts/novartis_novartis-careers-activity-7167819672107642880-Wh15/?utm_source=share&utm_medium=member_desktop

#ModelingAndSimulation #PKSciences #TranslationalMedicineQuants

Diversity & Inclusion / EEO

We 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

  • Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
  • Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098

Role Requirements

Essential requirements:
• Ph.D. in biology, pharmaceutical sciences, bioengineering, biophysics, or a related field with 6+ years of industry experience, or a master’s degree with 10+ years of industry experience. Candidates with a Pharm.D. or background in mathematics or other quantitative fields and a deep understanding of biological concepts will be considered.
• Extensive industry experience in pharmacokinetics and pharmacodynamics (PK/PD), quantitative systems pharmacology (QSP), and/or physiologically based PK (PBPK) modeling is required.
• Expert level proficiency in core modeling fundamentals is required, including scripting languages (e.g., MATLAB, R), construction of ordinary differential equation (ODE) models, parameter estimation, and data visualization.
• Demonstrated ability to communicate modeling results to a multidisciplinary audience to facilitate decision-making. Demonstrated ability to independently develop and implement modeling strategy across a disease area and/or modality platform.
• Fluent in English (oral and written)

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
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.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $166,400 – $249,600/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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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? https://www.novartis.com/about/strategy/people-and-culture

Join 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: https://talentnetwork.novartis.com/network

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Principal Scientist, Translational Modeling & Simulation, Novartis

About the Role

The position is located in Cambridge, MA and will not have the ability to be located remotely.

#LI-Hybrid

About the role:

We are seeking an experienced translational modeler eager to accelerate drug discovery & development by facilitating rigorous decision making with modeling & simulation, from target identification to first-in-human studies and beyond. You will work in a multi-disciplinary environment with opportunities to engage in projects that span different therapeutic modalities.

This role reports to a PK Sciences Translational Modeling team lead within Translational Medicine in Biomedical Research.

Key responsibilities:

• Act as the Translational M&S representative on programs in oncology, developing and executing modeling strategies, contributing to project team discussions, and guiding therapeutic design and dose selection decisions.

• Build and apply QSP and physiologically based PK (PBPK) models that link drug pharmacology, tissue biodistribution, mechanism(s) of action, and biological outcomes.

• Advance the development of integrated modeling platforms that bridge data and knowledge across preclinical species and patients, partnering with discovery project teams as well as the preclinical safety and pharmacometrics groups.

• Contribute to programs across therapeutic modalities and disease indications, as needed. Novartis has a wide portfolio with hundreds of drug discovery and clinical development projects and you will have opportunities to grow and develop as you apply modeling insights to diverse projects.

• Proactively seek opportunities to increase the impact and awareness of translational modeling through communications with internal and external audiences.

https://www.linkedin.com/posts/novartis_novartis-careers-activity-7167819672107642880-Wh15?utm_source=share&utm_medium=member_desktop

Diversity & Inclusion / EEO

We 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

  • Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
  • Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098

Role Requirements

Essential requirements:

Ph.D. in biology, pharmaceutical sciences, bioengineering, biophysics, or a related field, or a master’s degree with 4+ years of industry experience. Candidates with a Pharm.D. or background in mathematics or other quantitative fields and a deep understanding of biological concepts will be considered.

Prior experience in quantitative systems pharmacology (QSP), pharmacokinetics and pharmacodynamics (PKPD), and/or physiologically based PK (PBPK) modeling is strongly preferred.

Expert level proficiency in core modeling fundamentals is required, including scripting languages (e.g., MATLAB, R), construction of ordinary differential equation (ODE) models, parameter estimation, and data visualization.

Demonstrated ability to communicate modeling results to a multidisciplinary audience to facilitate strategy and decision-making.

Fluent in English (oral and written).

#ModelingAndSimulation #PKSciences #TranslationalMedicineQuants

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards

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

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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,400 – $195,600/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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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? https://www.novartis.com/about/strategy/people-and-culture

Join 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: https://talentnetwork.novartis.com/network

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Director, Scientific Governance PKS, Novartis
May 16, 2024
USA

Summary

About the role: This position will be located in Cambridge, MA and will not have the ability to be located remotely. #LI-Hybrid As the Director, Scientific Governance PKS you will provide regulatory expertise and scientific leadership in the drug development process of Biotherapeutics including Cell and Gene (C&G) therapies, in close collaboration with internal and external partners.

About the Role

Your Key Responsibilities:

  • Derive recommendations and propose solutions for tailor-made and integrative drug disposition questions in the Bx arena (Bx Portfolio risk management)
  • Support development of an integrated pre-clinical, clinical, and bioanalytical strategy for Bx compounds (incl PK/PD/IG data integration assessment) and, in collaboration with subject matter experts for small molecules, the LMW component of new modalities (as e.g. protein conjugates)
  • Propose and review ADME/BA solutions and action plans to guide the drug development process
  • Act as a Scientific Liaison to identify, test and implement new and emerging BA-related technologies to enable BA support of a very diverse drug pipeline
  • Work with key stakeholders in the Novartis Biologics Research Center (BRC), participate in biotherapeutics consortia (such as IQ), develop a sustainable support model for C&G programs including consideration of BA needs, leveraging of Vendor Center of Excellence expertise, and, in collaboration with line function leaders, optimizing the outsourcing strategy incl. quality assessment of Bx assays
  • Support Due Diligence, Asset Integration activities and Deep Dives. Coordinate strategy and execution with all BA functions
  • Review of Submission Documentation (e.g. IND, CTD) and responses to Health Authority Queries
  • On-demand, resume a (part-time) PTM role for one or more new modalities projects in the pre-clinical and clinical arena. Ad hoc participation in Project GPTs together with PKS PTM
  • Connect scientists across PK Science (PKS) department, encourage use of existing tools and processes, leverage models and resources and assure appropriate interpretation and presentation of (non)clinical and bioanalytical data
  • Foster optimal compound characterization during (pre)clinical development
  • Practice streamlined/consistent development approach in line with internal and external guidelines. Maintains current scientific and regulatory/legal expertise within the scope of Bx
  • Recommend on the optimal use of different tools across BA expert areas and line functions. Advice on assay designs and protocols
  • Provides training and mentoring opportunities to DD associates for the entire spectrum of technical disciplines
  • Capture learnings and themes across projects, leverage experience from one project to another and across TA’s

 

Novartis EVP Manifesto.mp4

 

Essential Requirements:

  • PhD/MD in Natural Biological Sciences or related field.
  • In-depth directly related experience in Bx-sciences
  • 10+ years of experience in the Bioanalytics/C&G therapeutics field
  • Several publications or opinion papers in the field
  • Active involvement in inter-company consortia such as AAPS, EBF, IQ, etc.
  • Current knowledge of scientific and regulatory areas (including GxPs) affecting Bx issues worldwide
  • Familiarity with regulatory agencies/functions
  • Excellent interpersonal, leadership and teamwork skills.
  • Excellent understanding of drug development processes in Bx arena
  • Excellent knowledge of design/structure of Bx studies and good knowledge of closely related areas
  • Strong communication and writing skills
  • Well-developed, effective organizational skills (e.g. planning, project management, time management)

 

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 $183,200 – $274,800/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.

 

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? https://www.novartis.com/about/strategy/people-and-culture

Join 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: https://talentnetwork.novartis.com/network

Biomedical Research

Pharma Research

USA

Cambridge (USA)

Research & Development

Full time

Regular

No

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