Global Project Head (GPH), Ophthalmology

Sanofi•Cambridge, MA

23h•Onsite

About The Position

The Ophthalmology Development Global Program Head (GPH) is a key position that oversees early and late development activities and is responsible for shaping asset strategy as well as managing execution. This role is focused on multiple projects from IND-enabling studies, first in human studies to proof of concept and registrational trials. This is a highly visible role that will work closely with the Research and Development teams and leaders in the therapeutic area to build and expand the portfolio in Ophthalmology. The GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals. The GPH establishes the goals for the global project team (GPT) 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 with regards to the projects and scientific disclosures and will interact with opinion leaders and consultants. Success in this role requires the ability to influence and lead at the highest possible level. This role will require scientific excellence, integrative thinking and strong interpersonal skills as well as ability to innovate and think creatively, engage multiple internal and external stakeholders, and make key decisions.

Requirements

Medical Doctor, or PharmD/PhD in relevant area
Deep expertise in Ophthalmology or Retina/Gene Therapy Clinical development
Must have either 6 yrs of experience in drug development or 10 years in the industry, within therapeutic area
Excellent communication skills
Fluent in English (verbal and written communication)
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 individuals

Nice To Haves

Strong scientific background with deep understanding of drug development; background in ocular gene therapy clinical development is highly preferred
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

Responsibilities

Owns the overall program strategy and leads the international cross functional team to meet program objectives
Demonstrates deep scientific, technical and clinical expertise in Ophthalmology and/or gene therapy
Oversees development planning, execution and budget
Participates in life cycle management strategy planning in collaboration with commercial 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
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
Demonstrates excellent analytical and judgement skills
Ensures that team members are adequately qualified and trained in the task they are required to perform.
Leads cross functional team with appropriate responsibility and accountability across team members; ensures 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
Ensures timely submission and dissemination of clinical data
Supports the planning of advisory board meetings
Establishes and maintains appropriate collaborations with knowledge experts
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.