Job Description Summary

About the role:

#LI-Hybrid

This position can be based in East Hanover, NJ or Cambridge, MA.

Translational Medicine (TM) is the clinical research arm of the Novartis Bio Medical Research organization and includes over 900 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.

TM Clinical Pharmacology is a cross-functional team, which is specialized on the design, clinical execution and reporting of First-in-Human (FiH) and Clinical Pharmacology studies across all TM therapeutic areas. The operating model is built upon a strategic outsourcing partnership with qualified and specialized CROs, in which the Novartis team maintains sponsor oversight and retains the strategic elements of the studies. As part of TM Clinical Pharmacology, you will help to develop therapies for patients by providing clinical operations leadership and expertise to support both early and late-stage global programs across all BR therapeutic areas in a role that significantly affects the entire Novartis drug development pipeline.

The Clinical Sciences Director in Clinical Pharmacology (CP) is accountable for the clinical, scientific and operational strategy of all assigned global TM projects, including leading the planning, implementation and delivery of all aspects of TM studies. The Clinical Sciences Director will have a high impact on the overall clinical pharmacology strategy and decision making by providing expert guidance, input and recommendations on CP activities and process.

Job Description

Key Responsibilities:

Provide clinical leadership and strategic and scientific input for all clinical deliverables across assigned projects and programs within BR/TM. Focused on Clinical Pharmacology (CP) portfolio of early phase and submission-enabling profiling clinical trials for Novartis.
Lead and successfully implement strategic initiatives for CP, CS&I, and/or TM/ BR, as assigned. Provides input and insight to CP strategy and implements the vision of the function. Organizes and coordinates the CP strategy.
Drive operational excellence through oversight of internal CP operations and CP Partnership model processes to ensure continuity, consistency and quality.
Lead key aspects of the CP portfolio in close collaboration with the Clinical Pharmacology Global Head and CS&I Clinical Pharmacology Head. Represents CP/CS&I at TM/BR project team meetings, inputs to and drives CP and project strategy.
Partner with line functions to gain input and alignment and manage internal and external stakeholder expectations. Develop strong partnerships with key internal and external partners to optimize quality/innovation of clinical study design, execution, reporting and publication.
May lead highly scientific, complex BR studies end-to-end, directing all aspects of strategic planning, execution and study management. As independent leader of the global, cross functional, cross-divisional clinical study team delivers on BR and Development objectives.
Responsible for implementation of best practices and standards for trial management and clinical operations including sharing lessons learned. Represent group on initiatives; may serve as Subject Matter Expert as appropriate. Contribute to talent and career development of staff. In collaboration with the relevant manager, contribute to hiring/interview/onboarding and mentoring process for new hires.
May have accountabilities for leading and managing a team of clinical pharmacology project managers, ensuring the quality and timeliness of the clinical pharmacology deliverables, and representing the clinical pharmacology function in internal and external forums. Accountable for talent attraction and retention; supporting career growth and development.

Essential Requirements:

Education: Bachelors in life science/healthcare required; Advanced degree (or equivalent education) in life sciences/healthcare preferred (Masters, PhD/PharmD)
Approximately 10+ years in clinical operations with clinical trial and drug development experience.
Demonstrated success in developing, leading and implementing key strategic projects and initiatives. High learning agility and proficiency in managing multiple priorities.
Demonstrated knowledge and ability to confidently and independently drive complex collaborations in a team environment through unpredictable circumstances and higher paced change.
Track record of successfully managing multiple complex global clinical trials or clinical projects concurrently, supported by experience in clinical operations. Superior leadership and problem-solving skills.
Excellent operational project and program management experience including excellent planning, prioritization, problem solving and organizational skills. Demonstrated operational excellence and scientific contribution to clinical projects.
Strategic thinking: create major innovations, ability to network with and influence opinion leaders, clear and logical presentation of complex strategic issues.
Clear written and verbal expression of ideas, an active/proactive communicator. Excellent interpersonal skills, with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships.
High level of customer orientation awareness and focus. Excels working independently and in a team environment, being flexible and adapting in a changing environment.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $222,400 and $333,600/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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com 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 Range

$222,400.00 - $333,600.00

Skills Desired

Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring