Global Project Head, Rare

Global Project Head -AATD

• SAR

Development

The Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and / orTherapeutic 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.

The GPH establishes the goals and will support staff within the program and participates in strategic planning for, and oversight of, the development activities of his / her area of responsibility. The GPH will be delegated such responsibilities as interaction with regulatory / health authorities (HA), approval of documents and product label, as appropriate. 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 clinical, clinical pharmacology, pre-clinical, and quality data relevant to the molecule of interest

Critically reads and evaluates relevant literature with deep understanding of the data and status from competitive products

Interacts with internal and external stakeholders

Owns the overall program strategy and leads the international cross functional team to meet program objectives

Proposes strategies for interactions with HAs

Participates in life cycle management strategy planning in collaboration with marketing teams

Establishes project goals in alignment with functional resource allocation, goals and objectives

Ensures operational plans are integrated across all functions

Oversees development planning, execution and budget in cooperation with relevant team members

Management and Career Development :

Ensures that direct reports are adequately qualified and trained in the task they are required to perform. 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

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 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.

Basic Qualifications :

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)

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

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.