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Global Project Head, Rare

5+ years
$258,750.00 - $373,750.00
10 Sept. 12, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Project Head, Rare – AATD (SAR447537)

Location: Morristown, NJ | Cambridge, MA
Department: Development
Salary Range: USD 258,750.00 – 373,750.00


About the Role

The Global Project Head (GPH) leads and coordinates the Global Project Team (GPT), driving program strategy, execution, and alignment with corporate R&D priorities. Reporting to the Senior GPH and/or Therapeutic Area Head, this role requires strong leadership, scientific expertise, and cross-functional collaboration to guide drug development from early stages to lifecycle management.

The GPH ensures regulatory strategy, scientific disclosures, communication, and stakeholder interactions are executed with excellence, while also supporting team growth and organizational goals.


Key Responsibilities

Scientific & Technical Expertise

  • Maintain deep expertise in the therapeutic area, including clinical, pre-clinical, pharmacology, and quality domains.

  • Continuously monitor literature and competitive products for strategic insights.

  • Own program strategy and lead cross-functional international teams.

  • Propose and implement health authority (HA) interaction strategies.

  • Support lifecycle management in collaboration with marketing teams.

Program & Strategy Leadership

  • Define program strategy, Target Product Profile (TPP), and value proposition.

  • Lead development of global project plans and regulatory strategies with GPT members.

  • Implement clinical development and lifecycle management plans aligned with registration and market access goals.

  • Ensure integration across R&D and CMC functions for program deliverables.

  • Oversee program budget, timelines, and execution.

Regulatory & External Engagement

  • Oversee preparation of regulatory documents, dossiers, and labeling negotiations with HAs.

  • Manage responses to HA questions and labeling enhancements.

  • Ensure timely dissemination of clinical and scientific data.

  • Lead and delegate interactions with:

    • Health authorities

    • Advisory boards

    • Patient advocacy groups

    • Key opinion leaders

    • Alliance partners and committees

Collaboration & Communication

  • Chair Joint Development Committees and represent team in alliance partner steering committees.

  • Contribute to brand optimization strategy alongside Market Access, Global Commercial, and Medical Affairs.

  • Support publication strategy with Medical Affairs and communication with Commercial and Investor Relations.

Team & People Leadership

  • Select, mentor, and develop cross-functional international GPT members.

  • Set team objectives and support creation of individual development goals.

  • Ensure direct reports are trained and qualified.

  • Provide matrix leadership across GPT functions, including:

    • Clinical Operations

    • Regulatory Affairs

    • Safety

    • Translational Medicine

    • Statistics

    • CMC

    • Project Management


Qualifications

Basic Requirements

  • MD, PhD, or equivalent advanced degree.

  • 5+ years of clinical/scientific experience or 10+ years of industry experience in therapeutic area.

  • Pulmonary disease experience preferred.

  • Fluency in English (written and spoken).

Preferred Qualifications

  • Strong academic/scientific background with deep therapeutic expertise.

  • Proven ability to lead cross-functional, global teams.

  • Excellent networking, communication, and negotiation skills.

  • Strong knowledge of global drug development and market access pathways.

  • Skilled in project management, budgeting, and resource allocation.

  • Strategic thinker with ability to execute operationally.

  • Strong problem-solving, conflict resolution, and decision-making skills.

  • Embraces Sanofi’s values, vision, and mission.


Why Join Us?

  • Contribute to breakthrough science and rare disease innovation.

  • Access global career opportunities with promotions, lateral moves, and international roles.

  • Comprehensive rewards package including:

    • Competitive compensation

    • High-quality healthcare coverage

    • Prevention and wellness programs

    • Minimum 14 weeks gender-neutral parental leave

  • Be part of a diverse, inclusive, and future-focused team.


Diversity & Inclusion

Sanofi is an Equal Opportunity Employer committed to diversity, equity, and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, veteran status, or other protected categories.