Success Profile

Courageous
Results-driven
Proactive
Problem-Solver
Leadership
Team player

Description

Drug Metabolism & Pharmacokinetics (DMPK)

Sanofi’s Global Research Platform is comprised of the following departments: Integrated Drug Discovery; Large Molecule Research; Pre-clinical Safety; Translational In vivo Models; and Drug Metabolism & Pharmacokinetics with each department focusing on specific enabling technologies, with development resources available in each Hub.

Working in close collaboration with the other entities in Sanofi’s Global Research Platform and the Hubs, the mission of DMPK is to support Therapeutic Area clusters to optimize, select and evaluate development candidates for optimal properties of target engagement and minimal risks related to bioavailability, duration of exposure or covariates driving variability. Main outcomes include selection of most promising scaffolds; optimization of chemical series, therapeutic proteins, and other modalities; demonstration of target engagement and establishment of PK/PD relationships; and continuous evaluation and refinement of translational parameters affecting probability of success in clinical studies. At Sanofi multiple modalities are at the TAs' disposal including synthetic molecules, mono-, bi & tri specific antibodies, fusion proteins, Nanobody compounds and gene therapies (not inclusive).

The Global Head of Modelling & Simulation, DMPK, is responsible to provide leadership and functional management of modelling & simulation (M&S) activities for all therapeutic areas including Rare and Neuro Diseases, Oncology, Inflammation & Immunology and Genomic Medicine. The M&S team plays a key role in designing, analyzing, interpreting and integrating preclinical and clinical data to enable dose projections, study design, and early regulatory submission enabling quantitative decision making during drug discovery and early development programs. The team members employ various model informed drug discovery and development approaches such as mechanistic disease and quantitative systems pharmacology (QSP) modeling, preclinical and clinical empirical PK/PD, and population mixed-effect PK/PD/efficacy modeling. This position oversees all functional quantitative activities and provide strategic leadership at portfolio level within M&S and cross functionally. The position expected to provide mentorship and foster state of art modeling and simulation approach using empirical and mechanistic mathematical framework including AI and machine learning if applicable using totality of internal and external databases supporting new modalities including RNA based therapies, gene therapy, bispecific and directed monoclonal antibodies (mAbs) and small molecules.

Additional responsibilities will include, but are not limited to

• Lead the global team of M&S scientists within DMPK to support the Sanofi Research and Early Development portfolio up to first-in human studies

• Lead the global team of M&S scientists to support the project experts within DMPK and to collaborate with the M&S scientist of other R&D functions e.g., Clinical Pharmacokinetics, Translational Disease Modelling, and Biopharmaceutics

• Lead, mentor, and provide strategic guidance for all therapeutic areas of interest within M&S function and provide strategic oversight and tactical support for preclinical and translational modeling and simulations

• Building center of excellence in M&S using appropriate quantitative frame works such as QSP, empirical PK/PD, disease progression modeling, and AI/machine learning approaches to provide quantitative input for new modalities such as RNA based therapies, gene therapy, bispecific and directed mAbs and small molecules utilizing totality of internal and external data

• Provide strong employee centric environment fostering sense of project ownership and employee development opportunities

• Work cross functionally with other members of Research & Development, Clinical Pharmacokinetics, Translational Disease Modeling, Toxicology, Biomarker and Clinical Bioanalyses and the Therapeutic Area units to coordinate drug research & development strategies and provide portfolio level quantitative input to enhance drug development and decision making in appropriate milestones

• Provide expertise and guidance to the Quantitative Pharmacology Alignment Committee

• Ensure staffing and processes are in place to enable adherence to drug discovery and development timelines for critical preclinical and clinical translational MIDD deliverables.

• Apply deep domain experiences to conceptualize MIDD approaches to provide model-based insights for development decisions in the early development phase.

• Identify critical capabilities and resources needs to achieve functional needs. Oversees academic collaborations and outsourcing and build the right balance of internal versus external capabilities.

• Provide appropriate leadership to project team members and regional heads

• Drive towards publication paths & branding of Sanofi DMPK.

Requirements

• PharmD, MD, or PhD level degrees (minimum of 12 years) in relevant area such as Pharmacy and Pharmaceutical Sciences, Pharmacokinetics and Biopharmaceutics, Drug Metabolism and Pharmacokinetics, Pharmacology, Toxicology, Medicine, Engineering degree with PhD and relevant biological experiences or System Biology/Data Sciences.

• Demonstrated leadership experiences and capability in the biotech and pharmaceutical industry with people management experiences to provide strategic leadership and mentoring.

• Deep and broad experience in non-clinical and clinical drug development.

• Strong track record of regulatory filing (IND/NDA/BLA) and responding to regulatory agency questions.

• In depth knowledge of global regulatory requirements and guidance on modeling and simulations.

• Experienced matrix team member and a leader of skilled professional scientists

• Good communicator, with the ability to influence as needed

• Strong organizational and interpersonal skills

• Expertise in developing people & teams

• Proven ability to develop innovative solutions to organizational and scientific problems

• Able to balance big picture thinking without missing key details

• A change agent with new ideas and the energy and vision to create a more agile and functioning organization

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.