Summary
About the Role
Key Responsibilities:
Partner with PCS Project Team Member (PTM) on their programs as DART development plans or issues need to be addressed, including interactions with the health authority.
Participate as an ad hoc member on Therapeutic Area strategic teams to address DART plans for portfolio.
Participate in PCS target teams to address project DART plans
Proactively maintain current knowledge of scientific and regulatory areas affecting drug safety issues worldwide including DART, Good Laboratory Practices (GLP), animal welfare regulations, and drug development process.
Respond to Health Authorities (Federal Drug Administration; EMEA, etc.) regarding questions and labeling discussions on DART issues
Liaise with Clinical Research Organizations on DART studies as Study Monitor and/or scientific expert in DART. May also serve as Study Monitor to coordinate the monitoring/reporting of sophisticated DART external studies. This includes facilitating effective communication between Study Director and Novartis PTM, Principal Investigators, etc., providing scientific input to study design, establishing study protocols, supervising the study conduct and raw data, evaluating study data, and finalizing study reports on time.
Maintain expertise in scientific field and knowledge of relevant regulatory guidelines.
Write Standard Operating Procedures, internal guidance documents where appropriate.
Participate in project teams/task forces as required.
May be PCS part-time PTM and serve on target teams.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $151,200 and $226,800/annually at the Associate Director level and $183,200 - $274,800/year at the Director level; 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.
Essential Requirements:
The ideal location for this role is East Hanover, NJ or Cambridge, MA site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 5% travel.
This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered (Associate Director/Director).
Minimum 8+ years’ experience required at the Associate Director level in a nonclinical drug development scientific field (e.g., study director, project team toxicologist or pharmacologist); 12+ years’ experience required at Director level.
PhD in Pharmacology, Toxicology or a related biological science (particularly Immunology, Cell Biology, Biochemistry and Virology) or an MD/DVM/ PharmD or equivalent with a strong background or equivalent work experience.
Awareness of global health authority guidance and expectations for nonclinical programs supporting regulatory applications.
Experience in direct or written communication of strategy and data to global health authorities.
Leadership in cross-industry organizations (discipline-related or related to drug development).
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.
Excellent interpersonal, leadership, organizational skills (e.g., planning and time management) and partnership skills. Excellent oral and written communication and influencing skills. Highly efficient, self-motivated, flexible and able to work independently and efficiently under time constraints.
Additional requirement at Director level is the ability to mentor and coach new Program Team representatives from PCS.
Desirable Requirements
• Preclinical development of small molecule, biotherapeutics and/or gene and cell therapies and the safety issue awareness of these modalities.
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.
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
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