Global Project Head (GPH), Ophthalmology

Job title: Global Project Head (GPH), Ophthalmology

Location: Morristown, NJ / Cambridge, MA

About the job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

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.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main 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

Management and leadership responsibilities:

• 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

Regulatory responsibilities:

• 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.

About You

Required Qualifications:

• 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

• Travel up to 20%, domestic and international

Preferred Qualifications:

• 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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. 

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.