Global Project Head, Rare

Role Summary

Global Project Head, Rare – Responsible for leadership, supervision, and coordination within the Global Project Team to achieve program objectives across development activities, regulatory interactions, and strategic planning. Plays a key role in multiple stages of drug development and ensures alignment with R&D and Business Unit priorities.

Responsibilities

• Defines program strategy, target product profile, and value proposition with GPT and Global Brand Team stakeholders
• Defines global project plans and regulatory strategy; leads global clinical plans and life-cycle management plans and post-marketing commitments across regions
• Ensures input from platforms and clear mandates to deliver against clinical plans
• Leads cross-functional R&D and CMC deliverables for preclinical, clinical, and quality studies
• Manages regulatory documents and labeling negotiations with health authorities
• Ensures timely submission and dissemination of clinical and scientific data with GPT members
• Manages interactions with external stakeholders (regulatory authorities, KOLs, advisory boards, patient groups, internal stakeholders, and alliance committees)
• Collaborates with alliance partners for program alignment across indications
• Chairs Joint Development Committee and represents team at Joint Steering Committee with Alliance partner
• Contributes to R&D components of brand optimization, and to publication and communication strategies
• Direct management of clinical leads; matrix leadership across GPT members (project management, clinical operations, regulatory, safety, translational medicine, statistics, CMC, IA)

Qualifications

• Medical doctor or doctor/scientist
• More than 5 years of clinical or scientific experience, or more than 10 years industry experience in the therapeutic area; pulmonary experience a plus
• Fluent in English (verbal and written)

Preferred Qualifications

• Strong scientific and academic background with deep understanding of the disease
• Experience leading and managing groups of professionals
• Strong leadership to manage international, cross-functional teams
• Strong networking ability in cross-cultural environments
• Excellent interpersonal, communication, presentation, and negotiation skills
• Extensive knowledge of global drug development and market access; skilled in project and budget/resource management
• Strategic thinking with scientific and technological understanding
• Performance-oriented with ability to meet timelines and execute strategy
• Outstanding communicator with problem-solving, conflict resolution, and decision-making skills
• Aligns with company values and mission; knowledge of AATD (alpha-1 antitrypsin deficiency)

Skills

• Strategic program management
• Regulatory strategy and HA interactions
• Cross-functional leadership and matrix management
• Clinical development and lifecycle management
• Stakeholder engagement and communication
• Publication and medical affairs collaboration

Education

• Medical degree or equivalent doctoral qualification