Translational Medicine Director/Associate*- Cardiovascular & Metabolic

Job Description Summary

Novartis BioMedical Research (BR) is the innovation engine of Novartis that collaborates across the company and beyond, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. Translational Medicine (TM) is the clinical research arm of Novartis BR, and includes about 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.

The TM Discovery & Profiling (TMDP) is a group of physicians and clinical researchers who drive innovative science from discovery to the patient through the selection, profiling, and effective development of medicines. Translational medicine experts oversee Phase 1 and 2 clinical trials to demonstrate proof-of-mechanism and proof-of-concept (PoC) in patients, as well as support for later Phase 3 development.

Translational medicine experts are key and highly visible members of global cross-functional project teams that design and implement early research and discovery projects, that then culminate in clinical PoC studies. Translational medicine experts collaborate with colleagues in biology and chemistry to identify targets in diseases with significant unmet medical needs and provide input on likely clinical development pathways.

The early clinical trials led by our translational medicine experts are among the most critical steps in drug development at Novartis. After PoC and if the program proceeds to full development, the translational medicine expert continues as a key member of the full development team up to and including registration.

As a Cardiovascular Metabolism (CVM) TM Expert, you will collaborate with the CVM TM Head or other experienced TM Experts to develop high value decision-strategies for the Translational Medicine component of drug development projects and to lead global cross-functional project teams through the PoC phase and beyond.

About the role

TME Director Cardiovascular Metabolism

Oversees the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations, serving a leadership role in the matrixed trial team. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements

Key Responsibilities

• Lead global project teams through PoC phase to drive implementation of the PoC strategy; participate in project teams through program life cycle from NTRC to registration
• Responsible for clinical portions of the Integrated Development Plan (IDP) through PoC.
• Acts as medical monitor for one or more clinical studies.
• Communicate clinical team matters to project teams and relevant decision boards (such as the Disease Area Decision Board).
• Convene relevant (internal and external) leaders to consider proposed approach to PoC.
• Evaluate clinical centers and foster communication with crucial collaborating investigators.
• Oversee publication and external presentation of PoC clinical study results.
• Accountable for compound related biomarker strategies; work closely with biomarker experts in implementation.
• In collaboration with research scientists identify, develop and implement strategy for preclinical support of program related objectives; this includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications and other relevant activities
• Participate in team presentations to Health Authorities as TM Expert

Essential Requirements

• Doctoral degree, MD required with clinical subspecialty training preferred in cardiovascular disease or endocrinology/metabolic disease; Additional PhD/post-doctoral equivalent research preferred.
• At least 1-2 years' experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience; 5 plus years to be considered for Director level.
• Recognized for medical expertise.
• Recognized for scientific expertise and passion for science: respected by colleagues internally and externally, having made significant contributions to the field and created / established new concepts; record of high quality publications in international scientific journals.
• Excellent written and oral communication/presentation skills.
• Independence: Able to work independently on study planning and execution, and with supervision on project planning.
• Leadership of Collaborations: Able to lead multidisciplinary teams in a matrix organization.
• Innovation: Seeks out new clinical discovery opportunities and PoC approaches.
• Additional consideration for candidates with advanced research experience in data science, genetics/genomics, artificial intelligence applied to clinical research, or digital/wearable health science.
• Fluent oral and written English

Additional information

This is a dual level 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.

The salary for this position is expected to range between

Associate Director: $ 225,400.00 - 322,000.00 - 418,600.00 USD Annual

Pay and benefits

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

Skills Desired

Clinical Trials, Cross-Functional Teamwork, Data Analysis, Data Monitoring, Drug Development, Drug Discovery Process, Medical Research, Medical Strategy (Inactive), People Management