Program Lead, Clinical Delivery - FSP

• Lead the creation and execution of clinical asset strategies and Phase 1 development plans, applying sound decision-making principles and strong knowledge of relevant therapeutic areas, trial designs, operational risks, and industry best practices.


• Provide scientific and operational input into clinical and regulatory documentation, including protocols, Investigator Brochures, risk profiles, annual reports, briefing documents, regulatory submissions, safety updates, clinical study reports, abstracts, publications, and manuscripts.


• Lead clinical project management processes, tools, timelines, and process maps, ensuring that development plans remain current and that progress, milestones, risks, and key decisions are clearly communicated across the broader molecule team.


• Oversee global clinical trial operations from planning through execution, including implementation timelines, trial activities, vendor selection and management, outsourcing plans, operational deliverables, and budget oversight.


• Partner with financial, regulatory, medical, cross-functional, and regional teams to manage clinical budgets, safety and monitoring processes, project changes, and operational priorities while ensuring milestones are delivered on time and within budget.


• Proactively identify clinical risks, root causes, and potential delivery challenges, developing mitigation and contingency plans and serving as a key point of contact for resolving implementation issues across internal and external teams.


• Build strong partnerships and lead effective communication across clinical teams, governance forums, leadership, affiliates, and external stakeholders, ensuring clear information is available to support timely decision-making.


• Work effectively through ambiguity and influence outcomes in a matrix environment through persuasion, negotiation, strategic thinking, problem-solving, and solution-oriented leadership.


• Contribute to a culture of learning agility and innovation while coaching and providing constructive feedback to colleagues and supporting the development of clinical capabilities.


• For applicable roles with people-management responsibilities, recruit, develop, and retain high-performing and diverse teams; manage workload and resources; support training, succession planning, talent assessment, performance and promotion processes; and foster an inclusive environment focused on learning and results.

Requirements

• Bachelor’s degree in a science-related field from an accredited college or university is required, with an advanced scientific degree considered an advantage.


• At least 3 years of pharmaceutical industry experience with direct responsibility for managing clinical studies is required, with 5+ years preferred, particularly experience in exploratory and biopharmaceutics clinical development.


• Strong knowledge of regulations and guidelines governing the conduct of clinical trials, combined with practical understanding of clinical development operations and submission requirements.


• Demonstrated experience using clinical project management processes and tools, with strong organizational skills and the ability to manage complex timelines, budgets, vendors, and multiple stakeholder groups.


• Proven ability to oversee third-party organizations and vendors, influence internal and external stakeholders, and build effective working relationships across functions, geographies, and cultures.


• Strong problem-solving capabilities, including the ability to anticipate systemic issues, identify root causes, implement corrective actions, and develop effective risk mitigation and contingency strategies.


• Excellent leadership, networking, influencing, negotiation, and interpersonal skills, with the ability to work effectively in a matrixed and virtual environment and deliver results through others.


• Strong self-management, adaptability, and organizational skills, with the flexibility to operate effectively across changing environments and multiple customer groups.


• Excellent written and verbal communication skills, with the ability to present clear, concise information to team members, stakeholders, governance groups, and senior leadership.


• Strong computer proficiency, including Microsoft Word, Excel, PowerPoint, and Microsoft Project, with advanced end-user skills in document preparation, spreadsheets, presentations, tables, graphics, and templates.


• Vendor management and contracting experience, along with proven coaching and mentoring experience, is preferred.


• Ability and willingness to travel up to 10% as required.

Benefits

• Flexible remote work arrangement based in Brazil.


• Opportunity to contribute to global clinical development programs with meaningful impact on the advancement of new therapies.


• Exposure to cross-functional, international, and virtual collaboration across the clinical development environment.


• Opportunities to develop leadership, scientific, project management, and strategic capabilities.


• Opportunities to coach, mentor, and contribute to the development of colleagues and clinical teams.


• An environment that values learning agility, innovation, strategic thinking, inclusion, and continuous improvement.


• Opportunities to work across the molecule lifecycle and contribute to high-impact clinical development decisions.