Director/Senior Director, Pharmacometrics (Early Development)

Job DescriptionThe Pharmacometrics community at Novartis comprises a group of about 80 quantitative scientists supporting a portfolio of more than 80 clinical development projects in 10 therapeutic areas every day. Quantitative sciences are a critical part of bringing these new medicines to patients. Pharmacometric Scientists bring innovative modeling and simulation skills to every aspect of clinical drug development over a wide range of disease areas and drug modalities. We are dedicated to creating a collaborative and supportive culture where teamwork and learning is emphasized and innovative problem solving is encouraged. Come and join an industry leader where you will have the opportunity to grow and contribute as a quantitative drug development scientist in early- and late-stage projects.
We have an opportunity for a Director, Pharmacometrics to lead strategy for clinical development programs with the Development Unit Leader. In this role, you will be responsible for driving the design and implementation of methodologies that help optimize drug development programs at the Development Unit and/or disease area level and manage a portfolio at the disease area level. You will lead and integrate input from different quantitative scientists impacting, clinical development, health authority interactions and represent the PMX function at internal and external decision boards, develop and mentor other pharmacometricians, and provide strategic, technical, operational and scientific leadership and solutions to the organization.
What you'll be doing: Your responsibilities include, but are not limited to:

• Lead the PMX contributions to the integration of relevant technical and disease area knowledge in the planning and execution of robust development programs.

• Represent Early Development Analytics (EDA) internally at decision boards and externally as the pharmacometrics expert, including regulatory interactions.

• Foster the integration of pharmacometric methodology into clinical development programs, and ensure that the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) are aligned on the pharmacometric strategy, its execution and delivery.

• Anticipate needs for PMX and strategic support at the disease/therapeutic area levels.

• May manage portfolio at Disease/Therapeutic Area level to support integration of pharmacometrics and relevant (target, compound, disease) knowledge in the planning and execution of robust development programs and strategies, independently but in coordination with the EDA PMX leader.

• Lead or significantly contribute to initiatives at global line function level, or cross-functional Analytics level, requiring coordination of diverse of team members.

• Lead the review and implementation of Health Authority guidances

• Develop and mentor pharmacometricians.

• May serve as manager of up to 6 PMX scientists providing support to the disease/therapeutic area.
This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require 1% travel as defined by the business (domestic and/ or international).
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. Minimum requirementsWhat you'll bring to the role:

• Ph.D. in pharmacology, biology, engineering, mathematics, statistics, computational science, or a field with significant modeling-related content (or equivalent) with 8+ years relevant work experience; 6+ years in applying, and mentoring model-based methods in pre-clinical and clinical drug development.

• Track record of identifying and leading contributions to external white-papers/policy that shape best practice in pharmacometrics. Has internally and externally established track record of developing/establishing pharmacometrics excellence. Record in contributing to scientific improvement/change initiatives.

• Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development

• Evidence of consulting skill in the drug development context, i.e. within project teams and management boards; experience interacting with regulatory agencies.

• Clinical, pharmacological and therapeutic knowledge in one or more disease areas

• Proven expert scientific leadership skills demonstrated in facilitating and
optimizing the (pre/early/full-) clinical development strategy.

• Fluent in English (oral and written)
Desirable

• Excellent communication and presentation skills and in particular the ability to effectively represent pharmacometrics issues to a wide range of target audiences.
Why Novartis
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
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.
The pay range for this position at commencement of employment is expected to be between $192,000-288,000 a year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.DivisionGlobal Drug Development Business UnitCD&A GDD CountryUSA Work LocationBoston, MA Company/Legal EntityNovartis PharmaceuticalsFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular Shift WorkNoEarly TalentNo