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. Neurology Development is responsible for projects from before first in human to Phase 4. We are responsible for project strategy, clinical development plans and delivery. Development is the key “central hub” for clinical projects, and lead large teams from various line functions including clinical operations and translational medicine.
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.
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
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
- Ensures clinical data meets 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.