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This position can be based in Cambridge, MA or East Hanover, NJ (Cambridge preferred) and cannot be located remotely. This position will require 25% travel as defined by the business (domestic and or international).
About the role :
With 400+ projects from discovery through development in PK Sciences (PKS). PK Sciences (PKS) is a global organization of about 300 associates, situated within Translational Medicine (TM), the clinical research arm of NIBR. 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 organization, working across both Biomedical Research (BR) and the Global Drug Development (D) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology from discovery through approval and life-cycle management.
As a globally recognized leader in the discipline with specific subject matter expertise as it pertains to Global Health, you will lead a team of project team representatives comprised of drug discovery and development experts to ensure optimal support at all stages of R&D, all modalities, and across the therapeutic area for all applicable sites. As the PKS TA Head Global Health you will be responsible for delivering the PK science strategy and scientific excellence for the Global Health Disease Areas, Franchise, and the associated marketed products portfolio within PK sciences. You will drive the strategy and oversees the implementation of preclinical and clinical drug discovery and development activities, and all scientific activities within PK Sciences to ensure the success of the Global Health portfolio. Our goal is to change the practice of medicine for patients around the world, including previously underserved populations in developing regions.
About the Role
Key Responsibilities:
• Being the principal face of PK Sciences to Global Health Disease Area and Franchise / Business Unit partners. As such, the TA Head represents PK Sciences at TA governance boards (DADBs, Franchise / Business Unit leadership teams) and speaks with full authority for the department at those boards. The TA Head will develop close strategic partnerships with peers at the level of these governance boards to drive overall portfolio and project decisions and plans, and to contribute to and align on portfolio priorities.
• Assuming ultimate authority and responsibility to ensure that scientifically tailored, medically and regulatory compliant project specific plans are in place for every identified project at all stages, every modality and every geography within the portfolio.
• Working closely with BioMedical Research and Development project management to understand priorities and inform PTRs to adapt project plans in real time as appropriate. Working with Operations / Planning partners within PK Sciences to ensure that overall project and portfolio priorities are planned and executed as required.
• Developing and sustaining the therapeutic area specific expertise relevant to drug discovery, competitive landscape, risk benefit, regulatory requirements, best practices, and global Health Authority requirements and expectations. This knowledge is expected to be highly developed for the specific TA.
• Ensuring the high quality and timely execution of preclinical and clinical development plans and registration strategies, study protocols, reports, summaries and publications. Assists in ensuring seamless transfer of a project across the different phases of R&D using innovative tactics to solve complex scientific and operational problems that threaten to delay projects.
• Supports all regulatory filings and post approval commitments for compounds. Ensures high quality representation for all health authority interactions.
• Driving close interdisciplinary collaboration among the PK Science disciplines (Drug Disposition (ADME, BA) and Modeling & Simulation and Operations through the PTM and PK science sub teams to achieve a holistic and integrative perspective of the clinical pharmacology properties of candidates and drugs. Partner with other line functions to nominate members to PK Science sub teams.
• Leading high performing global team of high potential scientists, mentoring them to enable the highest level of strategic partnership with colleagues and innovative problem-solving on projects.
• Ensures recruitment and career development of PTMs through active participation in the performance management and talent planning processes. Provides on-boarding, training, and mentoring support.
Essential Requirements :
Education – PhD or MD required preferably in life science/healthcare or a related discipline.
Experience/professional requirement:
• Demonstrated managerial and leadership skills a in pharmaceutical or equivalent life sciences organization
• A minimum of 10 years’ experience in a pharmaceutical based company, Clinical Research Organization (CRO) or equivalent academic experience
• Track record of demonstrated expertise and experience in all aspects of drug discovery and development (as it pertains to PKS)Familiarity and experience with respective health authority, GCP and ICH requirements and interactions.
• Therapeutic area expertise, encompassing business strategy and trends is preferred.
• Innovative and critical thinking. Process and performance orientation, characterized by constant drive to improve both the science and working practice.
• Experience in either the successful development and/or registration of new medicines. Filing experience is extremely desirable.
• Successful development and implementation of innovative programs and processes.
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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 $222,400 to $333,600/annually 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
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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 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 & 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.
