Global Project Head, Clinical Complement Strategy
Cambridge, Massachusetts, Waltham, Massachusetts
This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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Global Project Head – Clinical Complement Strategy
The GPH is expected to help drive the growth of the rare blood disorders therapeutic area and build the overall complement strategy for Sanofi by being a leader in the area and challenging “the status quo”. The GPH position is responsible for shaping strategy as well as managing execution of the project/product. This is a highly visible role that will work closely with the development and research heads within the therapeutic area. The GPH should provide leadership, supervision, and coordination within the Global Project Team (GPT).
The GPH position requires an ability to achieve results through others and to support the senior management team in achieving corporate goals. The GPH establishes the goals for the staff within the program and participates in strategic planning for, and oversight of, the clinical, research and operational activities of his/her area of responsibility. The GPH are responsible for interaction with regulatory/health authorities, approval of protocols, informed consent documents, clinical study reports and product label. In addition, the GPH will be responsible for the communication strategy and scientific disclosures, and other documents related to the GPT’s work, and will interact with opinion leaders and consultants and directly manage the clinical development team.
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 R&D Organization and the Business Unit.
The GPHs core job responsibilities include those listed below, as well as all other duties which may be assigned.
Tasks, Scientific and Technical Expertise:
- Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders
- Owns the overall program strategy and leads the international cross functional team to meet program objectives
- Oversees development planning, execution and budget
- Participates in life cycle management strategy planning in collaboration with brand teams
- Proposes strategies for interactions with health authorities
- Establishes project goals in alignment with functional resource allocation, goals and objectives
- Ensures operational plans are integrated across all functions
- Is responsible for annual budget deliverables
- Has and maintains deep scientific, technical and clinical expertise in drug development
- Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
- Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
Management and Career Development:
- Ensures that team members are adequately qualified and trained in the task they are required to perform, including accountability for maintaining compliance training for direct reports
- 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
- Ensures clinical data meet all necessary regulatory standards
- Supports registrations, label submissions and modifications
- Manages Advisory Committee preparation and participation
- Scientific data dissemination
- Ensures timely submission and dissemination of clinical data
- Supports the planning of advisory board meetings
- Establishes and maintains appropriate collaborations with knowledge experts
- In addition to the above activities the GPH ensures that all activities of the GPT are conducted in compliance with current regulations, laws and guidance from FDA, EMeA, and CHMP, as well as with Sanofi’s policies and procedures.
- Medical Doctor preferably adult non-malignant hematologist or experience working with complement inhibitors
- Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)
- More than 5 years of clinical or scientific, or more than 10 years industry experience
- Fluent in English (verbal and written communication)
- Strong scientific and academic background with deep understanding of the disease
- 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 companion health care solutions (such as companion diagnostics or devices, as applicable) 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
- 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
The successful candidate will be required to sign and execute a restricted covenant upon hire.
The preferred location is in Cambridge/Waltham, Massachusetts, USA in order to be close to the majority of collaborators. For exceptional candidates, other locations may be considered.
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.
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.
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