What are the responsibilities and job description for the Director, Toxicology Multiple Therapeutic Areas position at Novartis?
Summary
Director, Toxicology Multiple Therapeutic Areas
This position will be located in the US (Cambridge, MA)
We are seeking a Director Toxicology that will provide nonclinical regulatory toxicology expertise on R&D project teams supporting the successful initiation of clinical trials and achievement of registration for drug candidates of various modalities. The Director level Project Team Member leads cross functional associates (i.e. Preclinical Safety Target Team) to develop and implement integrated nonclinical toxicology study plans, drafts regulatory responses and all required submission documentation and manages the respective project communication strategy within Preclinical Safety (PCS) and Novartis
About The Role
Key Responsibilities:
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.
To learn more about the culture, rewards and benefits we offer our people click here.
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
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
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 & 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.
Director, Toxicology Multiple Therapeutic Areas
This position will be located in the US (Cambridge, MA)
We are seeking a Director Toxicology that will provide nonclinical regulatory toxicology expertise on R&D project teams supporting the successful initiation of clinical trials and achievement of registration for drug candidates of various modalities. The Director level Project Team Member leads cross functional associates (i.e. Preclinical Safety Target Team) to develop and implement integrated nonclinical toxicology study plans, drafts regulatory responses and all required submission documentation and manages the respective project communication strategy within Preclinical Safety (PCS) and Novartis
About The Role
Key Responsibilities:
- Leads PCS Target Teams to design, integrate and interpret results of nonclinical safety assessment program including impact to drug development and/or project timeline
- Represents PCS on cross functional R&D project teams to design appropriately compliant and scientifically relevant nonclinical safety package
- Recognize the need for a “fit for purpose and modality” nonclinical program as needed and collaborate with line functions outside of PCS to accomplish this goal
- Participates in internal Novartis initiatives to improve use of nonclinical/translational safety data for drug development decisions.
- Manages communications and builds relationships between PCS and R&D project teams
- Negotiates with Global Health Authorities (HA) worldwide regarding safety issues, scientific interpretation and acceptability nonclinical safety package to support clinical trials and market approval.
- Responsible for authoring nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval
- May evaluate in/out-licensing opportunities and carries out technical Due Diligence activities upon request.
- Participates or leads internal and/or external cross-functional groups on key initiatives focused on PCS objectives and/or current nonclinical safety topics.
- Mentors colleagues on drug development strategy and project-related matters
- Minimum of 5 years experience as a nonclinical safety Project Team member; Demonstrated experience in the preclinical development of small molecule, oligonucleotides and/or biotherapeutics and the safety issue awareness of these modalities.
- 8 years experience in a nonclinical drug development scientific discipline (e.g. study director, project team toxicologist or pharmacologist).
- Demonstrated experience in direct or written communication of strategy and data to global health authorities, supporting clinical development and market approval.
- Knowledge of drug development strategy for immunomodulatory drugs
- Leadership in cross-industry organizations (discipline-related or related to drug development).
- Excellent interpersonal, leadership, organizational skills (e.g. planning and time management) and teamwork skills. Excellent oral and written communication and influencing skills. Highly efficient, self-motivated, flexible and able to work independently and efficiently under time constraints.
- Ability to focus and work on several projects simultaneously and to effectively manage conflicting expectations from the line unit, TA Strategy team and project teams in a matrix management environment.
- Customer focused thinking. Recognized ability to represent PCS on Novartis cross functional decision boards or other cross functional project teams.
- Recognized expertise in technical and scientific problem solving in a project driven, multi-disciplinary international environment.
- Ability to mentor and coach
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.
To learn more about the culture, rewards and benefits we offer our people click here.
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
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
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 & 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.
Salary : $185,500 - $344,500
