Global Project Head

GLOBAL PROJECT HEAD
The Global Project Head (GPH) is delegated a number of responsibilities by the Therapeutic Area Head to provide leadership, supervision, and coordination within the Global Project Team (GPT). At the core, the GPH serves as the CEO of the GPT. The GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals. The GPH also serves as the face of the program in interaction with senior stakeholders internally.
The GPH establishes the goals and will support staff within the program and participates in strategic planning for, and oversight of, the clinical and research activities of his/her area of responsibility. The GPH will be delegated such responsibilities as 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, 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 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.
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 stakeholders in GPT and GBT
• Defines global clinical plans and regulatory strategy for the program. Leads the implementation of the global clinical plans and/or Life-cycle management clinical development plans & post-marketing commitments aligned with the Target Product Profile, registration and market access objectives across regions.
• Responsible for the regulatory documents/registration dossier, answers to HA questions, labeling negotiations with HAs, and labeling enhancement
• Responsible for all medical components needed for maintenance of product licenses, ensuring the deliverables of all clinical leader assignments (e.g., Core Data Sheet generation/revision; clinical benefit-risk assessments for license renewals, responses to Health Authority).
• Responsible for ensuring the input from the Clinical and Scientific Operation platforms and the elaboration of a clear mandate to ensure deliverables against the agreed clinical plans.
• Management and delegation of interactions with external stakeholders on clinical aspects (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, Global Commercial and Medical Affairs, as Active member of GPT.
• Interacts with external stakeholders such as regulatory agencies and HTAs. Need to maintain or develop strong external network to support the development and the implementation of the clinical development plan.

• Ensures timely submission and dissemination of clinical and Scientific data
• Represent project during media interviews and IR calls

• Leads implementation of agreed clinical communication plans. Contributor to publication strategy with Medical Affairs.
• Direct management of Clinical Lead, and Indication teams globally ensuring delegation to the group and individual development plans for these employees.
• Matrix leadership and dotted-line management toward all GPT members, including GPM, clinical operations, regulatory, safety, translational medicine, statistics, CMC, I.A., etc.

• Working in matrix with cross-functional R&D and CMC functions, he/she ensure deliverables of Preclinical studies, clinical pharmacology studies, PK/PD and Immunogenicity assessment to support clinical development and registration, toxicology studies, Safety surveillance and Risk Management Plan (with GPV), CMC activities for the program to support clinical Development and Registration (with CMC team), DS/DP industrialization processes, supply chain, and Devices Development (with Industrial Affairs team)

• Work in collaboration with the alliance partner (when applicable) to ensure program strategic alignment across indications
• The GPH will interface with I&I development franchise leadership, supporting the activities of the franchise development innovation/clinical science group.

• 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.

Management and Career Development:

• Ensures that team members are adequately qualified and trained in the task they are required to perform. Including accountability and 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

Scientific and technical Expertise:

• Has and maintains deep scientific, technical and clinical expertise in the specific therapeutic area
• 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
• Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders
• Oversees development planning, execution and budget
• Owns the overall program strategy and leads the international cross functional team to meet program objectives
• Participates in life cycle management strategy planning in collaboration with marketing teams
• Proposes strategies for interactions with health authorities
• Establishes project goals in alignment with functional resource allocation, goals and objectives
• Responsible for generating support and implementation of clinical studies
• Ensures operational plans are integrated across all functions
• Is responsible for annual budget deliverables

Basic Qualifications:

• MD or PhD in relevant scientific discipline (Immunology or associated therapeutic area). MD Preferred.
• 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:

• 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
• Previous clinical development experience in I&I TA
• Medical Specialty/Expertise (or PhD) in Immunology, Allergy, Pulmonology, Rheumatology, or Dermatology

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