Project Head – Rare

Project Head – Rare

Requirements

• Medical doctor or doctor/scientist
• More than 5 years of clinical or scientific, or more than 10 years industry, experience within the field of the specific therapeutic area compounds; pulmonary experience a plus
• Fluent in English (verbal and written communication)

Responsibilities

• 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)
• Work in collaboration with alliance partner to ensure program strategic alignment across indications, as appropriate
• Chair Joint Development Committee, and represent team at Joint Stirring Committee for all key decision making with Alliance partner, as appropriate
• Contributor to R&D components of the brand optimization strategy in close collaboration with Market Access, 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 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.

Preferred Qualifications

• 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 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
• 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
• Embraces Sanofi’s values, vision and mission