Therapeutic Area Biomarker Lead/Biomarker Strategy – Cardiovascular and Metabolism

Novartis • Cambridge, MA

5d • Hybrid

About The Position

As a Cardiovascular and Metabolism (CVM) Therapeutic Area Biomarker Lead (TABL) (Director) you will lead the CVM disease area biomarker matrix team and be responsible for the development and implementation of “fit for purpose” biomarker strategies and providing an effective interface for transitioning projects from early to later stage clinical development. You will be a core member of CVM clinical project teams, engaged in Translational Data Science teams, and provide therapeutic area line function review for clinical protocols. As a TABL you will lead efforts to identify, develop, and drive disease, mechanistic and compound biology that serves the clinical and precision medicine approaches for the multi-indication CVM portfolio that focuses on heart failure, atherosclerosis, obesity and atrial fibrillation indications.

Requirements

• MD, MD/PhD, or PhD degree required, plus additional PhD/postdoc or equivalent level research
• Deep understanding of cardiovascular and metabolic disease epidemiology with particular emphasis on Atherosclerotic Cardiovascular Disease (ASCVD) that can be applied to questions of diagnosis, biomarker development and treatment monitoring strongly preferred
• Scientific excellence supported by recognized high quality publications; clinical and/or biological expertise in cardiovascular and metabolic diseases (Board certified or similar level preferred) with impact in ASCVD literature
• 5 plus years of independent leadership experience and external leadership/partnership in consortia and/or health authority initiatives
• Proven success in leading and partnering in multidisciplinary matrix teams across Pharma/biotech (clinical research thru healthcare applications), academic institutions, or commercial business functions including a mature biomarker strategy to support registration and/or launch
• Demonstrated ability to own an entire section of the portfolio as well as the phase package; Well-developed interpersonal skills with good presence and ability to influence and negotiate with senior leadership; experienced presenter and communicator
• Significant relevant experience after your MD/PhD/postdoc including quantitative expertise in biostatistics, bioinformatics, computer biology, statistical genetics, clinical imaging, machine learning, or data science; interpreting and publishing studies consisting of “omics” data e.g. genetics, genomics, proteomics; closely partnering with/leading data scientists
• Fluent in oral and written English; other languages e.g. German, French, Italian useful but not required

Responsibilities

• Delivering clinical project and disease biomarker strategies and plans across the early through late phase within the Cardiovascular and Metabolism portfolio and support relevant mature assets in the late phase portfolio
• Leading a dedicated matrixed group of Subject Matter Experts and project team representatives as well as key program stakeholders, to together develop biomarkers strategies for disease and/or assets across the Research-Development-Commercial continuum
• Representing Biomarker Development on Cardiovascular and Metabolism early and late Disease Area Decision Boards to identify, develop, and drive cardiovascular and metabolic disease and compound mechanistic biology, and precision medicine approaches for the portfolio
• Leading strategic translational data working groups centered on integrating and analyzing large-scale patient muti-modal data sets (omics, imaging, digital, etc.) to identify new indications, endpoints, and responsive patient subpopulations
• Representing BMD line functions in Therapeutic Area Line Function committees for clinical protocol development and operational milestone reviews
• Leading biomarker strategies and drive plans at the clinical team level as a Biomarker Strategy Lead
• Lead and/or contribute to BMD/TM/BR wide initiatives e.g. genetics, inflammation, imaging depending on background and expertise
• Stay up to date on clinical, disease, biology and scientific literature and competitor data for their respective disease areas
• Implementing strategies in close collaboration with the BMD global organization which includes over 150 associates with expertise in all aspects of biomarker science i.e. genetics, genomics, molecular and cellular, digital devices, imaging and data sciences
• Design and present the RDC biomarker strategy for transitioning and mature assets for late phase within their key pillar and ensuring study level alignment across the portfolio segment of focus

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees