Massachusetts Green Jobs

MassHire JobQuest Logo

Job Information

Sanofi Group Global Project Head, Rare Disease (Fabry) in Cambridge, Massachusetts

Position Overview: Global Project Head Fabry

The Global Project Head (GPH) is delegated various responsibilities by the Therapeutic Area Head to provide leadership, supervision, and coordination within the Global Project Team (GPT). The GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals.

The GPH establishes the goals and will support staff within the program and participates in strategic planning for, and oversight of, the development activities of his/her area of responsibility (marketed and investigational products for Fabry disease) to maximize the value propositions of the products across the life cycle. The GPH will be delegated such responsibilities as interaction with regulatory/health authorities (HA), execution of clinical studies, approval of documents and product label, as appropriate. In addition, the GPH will be responsible for the communication strategy and scientific disclosures, travel authorizations, expense reports and other documents related to the GPT’s work, and will interact with opinion leaders and consultants.

The GPH plays a role in several stages of drug development and helps assure that the group’s priorities are aligned with the strategic priorities of the research and development (R&D) Organization and the Business Unit. Some of the GPHs core job responsibilities include those listed below, as well as all other duties assigned.

Key Responsibilities:

Scientific and technical Expertise:

  • Has and maintains deep scientific, technical and clinical expertise in Fabry Disease and other lysosomal storage disorders (LSDs).

  • Understands and keeps updated with the clinical, clinical pharmacology, pre-clinical, and quality data relevant to venglustat.

  • Understands policies and procedures set forth by health authorities (regulatory and reimbursement agencies) globally and provides strategic oversight to ensure appropriate evidence is generated to support decision making.

  • Critically reads and evaluates relevant literature with deep understanding of the data and status from competitive products.

  • Interacts with internal (cross functional team leads and senior management) providing high level strategies and long-term vision of assigned work.

  • Takes a leadership role in the development of relationships, research collaborations and continued advocacy with external advisors in appropriate therapeutic areas.

  • Owns the overall program strategy and leads the international cross functional team to meet program objectives.

  • Proposes strategies for interactions with HAs.

  • Participates in life cycle management strategy planning in collaboration with medical affairs, market access, health economics and outcomes research (HEOR) and commercial teams.

  • Establishes project plan in alignment with functional resource allocation, goals and objectives.

  • Ensures operational plans are integrated across all functions.

  • Oversees development planning, execution and budget in cooperation with relevant team members.

  • Manages and oversees the execution of multinational clinical trials and research activities within R&D.

Management and Career Development:

  • Ensures that direct reports are adequately qualified and trained in the task they are required to perform. Works cross functionally to select appropriate team members

  • Sets team’s objectives, and works closely with direct reports to create individual performance and development goals

The major duties and responsibilities which the position is accountable for include:

  • Defines program strategy, target product profile, and target value proposition with all key stakeholder in GPT and Global Brand Team (GBT).

  • Defines global project plans and regulatory strategy together with the GPT members; leads the implementation of the global clinical plans and/or life-cycle management clinical development plans and post-marketing commitments aligned with the Target Product Profile, registration and market access objectives across regions.

  • Responsible for ensuring the input from the platforms and the elaboration of a clear mandate to ensure deliverables against the agreed clinical plans.

  • Working in matrix with cross-functional R&D and CMC functions he/she ensures deliverables of preclinical, clinical and quality studies needed for development and registration.

  • Responsible for the regulatory documents/registration dossier, answers to HA questions, labeling negotiations with HAs, and labeling enhancement together with the GPT members.

  • Ensures timely submission and dissemination of clinical and scientific data together with GPT members from all relevant functions.

  • Management and delegation of interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups, internal stakeholders and decision boards and alliance committees).

  • Contributor to R&D components of the brand optimization strategy in close collaboration with Market Access, HEOR. Global Commercial and Medical Affairs, as Active member of GPT.

  • Contributor to publication strategy with Medical Affairs and communication plans with Commercial and Investor Relations.

  • Direct management of clinical lead.

  • Matrix leadership and dotted-line management toward all GPT members, including e.g. project management, clinical operations, regulatory, safety, translational medicine, statistics, CMC, I.A.

Basic Qualifications:

  • Medical doctor (MD or equivalent)

  • More than 5 years of clinical or scientific, or more than 10 years industry, experience within the field of the specific therapeutic area compounds.

  • Fluent in English (verbal and written communication).

Preferred Qualifications:

  • Other advanced degree(s) (PhD, MS, MPH) in a relevant scientific discipline a plus.

  • Strong scientific and academic background with deep understanding of Fabry disease and other lysosomal storage disorders.

  • Knowledge of recent advances in drug development with respect to novel endpoints and clinical outcomes assessment (COA).

  • Experience in or demonstrated evidence for the capacity to lead and manage groups of professionals.

  • Strong leadership skills to manage international, cross-functional teams of highly skilled professionals.

  • Good networking ability in cross-cultural environment.

  • Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization.

  • In depth knowledge of global drug development activities including the development of other health care solutions along the whole value chain from research up to market access.

  • Skilled in project and/or budget/resource management.

  • Strategic thinking in combination with understanding science and technologies.

  • Track record of publications in high-impact peer-reviewed journals.

  • Knowledge of global regulatory processes and guidelines and experience with HA submissions.

  • Strong ability to collaborate with leaders from other functional areas.

  • Proficiency in principles of evidence-based medicine and clinical research methodology.

  • Performance oriented with ability to work along agreed timelines and a focus on strategy and execution.

  • Outstanding communicator, Excellent problem-solving, conflict-resolution and decision-making skills.

Key Performance Indicators:

  • Demonstrated contributions to product success.

  • Development and execution of strategies that address unmet medical needs and path to commercial success; anticipate scientific, regulatory and reimbursement/access trends and events that will affect Sanofi’s standing as a valued healthcare partner.

  • Expertise recognized within function, corporation and the healthcare field.

  • Anticipates communication needs to cross-divisional audiences and pre-empts issues with timely and effective action.

  • Maintain track record of scientific advancement in the Fabry disease.

  • Compliance with all relevant internal SOPs and external laws and regulations.

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.

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.

#GD-SA

#LI-SA

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.

DirectEmployers