Sanofi Group Head of BPIV Clinical Sciences in Cambridge, Massachusetts

Head of BPIV Clinical Sciences (Clinical Team Leader)

The Sanofi Pasteur organization's vision is a world in which no one suffers or dies from a vaccine-preventable disease.

The Company:

  • Produces more than 1 billion doses of vaccines yearly to immunize more than 500 million people in the world

  • Is the world’s largest producer of seasonal influenza vaccines

  • Is the world’s leading provider of inactivated poliomyelitis vaccine

  • Has broadest range of modern pediatric combination vaccines for children throughout the world

  • Is the world’s main provider of meningococcal vaccines with an unfaltering commitment to provide meningococcal vaccine for outbreaks control in West Africa

  • Has largest portfolio of vaccines for travelers and people living in tropical areas: typhoid, rabies, yellow fever, Japanese encephalitis, meningococcal meningitis, cholera, hepatitis A, hepatitis BToday, according to the World Health Organization (WHO), vaccines are available to protect against more than 26 infectious diseases. Sanofi Pasteur has the broadest available range of vaccines, protecting against 20 infectious diseases:Bacterial diseases:CholeraDiphtheria Haemophilus influenzae type b InfectionsMeningococcal InfectionsPertussisPneumococcal InfectionsTetanusTuberculosisTyphoid FeverViral diseases:Hepatitis AHepatitis BInfluenzaJapanese EncephalitisMeaslesMumpsPoliomyelitisRabiesRubellaYellow Feverand smallpox, eradicated in 1980 (vaccine produced as a measure in response to the threat of bioterrorism)Worldwide, Sanofi Pasteur is at the forefront of developing immunological solutions to prevent diseases for every stage of life. We are continuously harnessing new scientific knowledge and technologies to design safe and effective single-entity and combination vaccines against complex diseases for the world’s population.Working alone or in collaboration with third parties, the Company is developing vaccines against diseases for which there are pressing needs. Many are currently in development or submitted for approval, focusing on new targets and improved vaccines for every stage of life including:

  • new vaccines against infectious diseases for which no vaccines are currently available, such as hospital-acquired infections, e.g. Clostridium difficile and enterotoxigenic Escherichia coli (ETEC) infections;

  • new vaccines against the diseases that plague emerging countries, such as Zika;

  • new combination vaccines

  • vaccines to face a potential influenza pandemic

  • Quadrivalent influenza vaccines adapted for the elderly.The Head of BPIV Clinical Sciences is a key position to develop a clinical strategy for the broadly protective influenza vaccine (BPIV) project within the R&D organization. The position will be a dual reporting relationship to a biotech-like unit within Sanofi Pasteur R&D to develop BPIV, and the Clinical Sciences team. As BPIV has not entered into the clinic yet, novel, creative areas of clinical research are deemed necessary to complement our already successful and proven pipeline and portfolio of influenza vaccines by Sanofi Pasteur. The candidate should feel comfortable between the translational science space between discovery and proof of concept Phase 1/2 clinical trials. A track record in successful proof-of-concept achievement is a plus.This newly-created position has been established to primarily contribute to the strategic planning, design, management and execution of BPIV clinical trials covering all age groups and on a global scale. The Director of Clinical Research for BPIV will work with the Clinical Sciences team, in conjunction with the Clinical Programs team, and be responsible for conducting BPIV Phase I – III clinical trials on a global scale. Clinical trials are conducted to support vaccine products in the development pipeline and are conducted internationally, depending upon the geographic location of the affected areas and populations. It is essential that the right candidate believes in the positive impact that industry can make in the advancement of vaccines. Duties: The primary responsibilities for this position are:

  • Be able to work in preclinical space to design impactful and meaningful proof of concept influenza clinical trial designs and create the clinical and regulatory pathway through licensure of BPIV including discovery of biomarkers from the clinical trials

  • Medical monitoring of individual clinical trials or set of studies within a program to maintain patient safety and secure:

  • Compliance with ICH-GCP guidelines and internal procedures

  • Communication with principal investigators and study site coordinators in order to address any scientific and medically-related inquiries

The Director of Clinical Research is the medical expert on call for all relevant aspects associated with the trial and the program (including during site audits and inspections)

  • Clinical trial management from research to licensing, including ownership and strategic direction of Clinical Development Plans (CDP) and the subsets of the Common Technical Document (CTD)

  • Contribution to the strategic vision of the project and support of the project team as Clinical Sciences representative

  • Alignment of the CDP with Franchise objectives by working with the respective Clinical Franchise Leader or Clinical Portfolio Head

  • Clear, timely and consistent strategy across the clinical trials, reflected in the CDP and communicated internally in the organization

  • Lead the interpretation and critical evaluation of study results

  • Contribute to the generation and submission of documentation to Regulatory and Health Authorities including submission files, study reports, program dossiers, etc.

  • Oversee the operational aspects of the clinical trials and interact with internal team members and external clients

  • Review safety data from ongoing clinical trials as a key member of a Safety Management Team

  • Ensure the timelines and quality requirements of trials are clearly communicated and followed

  • Be a contributing member of the BPIV biotech unit and the Clinical Sciences organizations

  • Timely and accurate accomplishment of key project milestones including the design of the clinical development strategy, licensure submissions, and integration of clinical data for milestone decision processes

  • Participate actively in process improvement and other initiatives

  • Interact with members of the Program/Project Teams and other internal members (Research and Development, Chief Medical Office, Commercial Operations, Industrial Operations) in a positive and collaborative manner

  • Present Clinical data internally to senior management and externally to investigators, outside partners, regulatory agencies and public health agencies

  • As appropriate, serve as an ambassador for Sanofi Pasteur:

  • Representing the Company at scientific meetings

  • Author publications

  • Establish, develop and maintain a network of Key Opinion Leaders (KOLs) and leading scientists in the field

Performance expectations in the first year include:

  • Assimilate into the internal Clinical R&D team on a global scale - this includes working well with Central and Regional Clinical Sciences and Clinical Programs representatives

  • Assimilate into the BPIV biotech unit and the BPIV project team as the clinical representative to design and implement clinical studies for the broadly protective influenza vaccine project.

  • Ensure that project timelines and quality milestones are met

  • Contribute to the strategy for the clinical proof of concept and advanced development of BPIV and other assigned vaccines

  • Maintain the state of the art knowledge on clinical development for infectious diseases vaccines and particularly for influenza

  • Contribute to the internal and external distribution and communication of clinical data Position Location: This position is based in Cambridge Massachusetts. Compensation: This role will consist of a competitive overall package including base and bonus. THE ORGANIZATION: Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, oncology, innovative drugs, human vaccines, consumer healthcare, orphan products, emerging markets and animal health. Sanofi Pasteur is the vaccines division of Sanofi. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company is the largest in the world that is entirely devoted and dedicated to vaccines. Every day, the company invests more than €1 million in Research and Development. The mission of Sanofi Pasteur is to protect and improve human health worldwide by providing superior, innovative vaccines for the prevention and treatment of disease and by playing an active role in the immunization community to maximize vaccination coverage rates. Sanofi Pasteur is committed to providing vaccines to persons of all ages, developing technologies to facilitate the distribution and administration of vaccines locally, participating in the training of personnel who administer vaccines in the field, and conducting research on needed vaccines, especially including those that are needed primarily in developing countries, e.g. dengue fever and pandemic influenza. Sanofi Pasteur is continuously investing in state-of-the-art technologies to meet the anticipated growing demand of new and existing vaccines, expected to double over the next 5-10 years. The organization has 14 major production sites on 4 continents. Sanofi Pasteur has a strong commitment to Research and Development partnerships with major universities, research institutes, government bodies, biotechnology companies and contract research organizations. The Company's collaborations cover virtually all aspects of vaccine development, including early-stage research. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). www.sanofipasteur.com at http://www.sanofipasteur.com/ THE PERSON: Education:

  • Medical Degree Required

  • Infectious Diseases certification highly desirable; Immunology acceptable Specific Skills & Experience:

  • Experience in Infectious Diseases, vaccines, adjuvants, and influenza preferred; experience in Immunology acceptable

  • Experience in conducting clinical trials preferred; clinical trial protocol and writing, working knowledge of ICH/GCP guidelines and clinical research ethics preferred

  • Experience designing and conducting clinical trials to understand immune mechanism of action or to demonstrate proof of concept in vaccine development a plus

  • Experience conducting and designing non-clinical experiments a plus

  • EIS training very advantageous

  • Biotech or start-up experience a plus

  • Some regulatory experience a plus

  • Familiarity with IND submission process Personal Characteristics:

  • Team player, independent and with demonstrated initiative

  • Demonstrated organizational skills

  • Ability to network and communicate clearly

  • Personal drive to surpass timelines on projects

  • Politically astute, able to successfully architect internal and external networks to support the team mission

  • Ability to work well under pressure

  • Positive and welcoming personality

  • Intuitive drive for novel science

  • Inquisitive and willing to try novel approaches

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.