Program Lead, Clinical Delivery

This is a fully remote position, open to applicants in Brazil, +1 more country.

📋 Description

• Spearhead the development and implementation of exploratory and biopharmaceutics clinical development plans at the molecular level.

• Offer technical direction and operational management for clinical research trials within the development strategy.

• Strategize and execute clinical trial and submission milestones promptly and within budget throughout the molecule's lifecycle.

• Act as the primary operational liaison for trials from design through to execution.

• Develop and oversee timelines, outsourcing strategies, vendor management, and budgets.

• Guide the formulation of clinical asset strategies for Phase 1.

• Provide consultation on clinical and regulatory documents, encompassing protocols, Investigator Brochures, risk profiles, annual reports, briefing documents, NDAs, safety updates, CSRs, abstracts, publications, and manuscripts.

• Stay updated on relevant disease states, targets, competitors, industry trends, and best practices.

• Direct the implementation and integration of clinical project management processes and tools.

• Collaborate with Third Party Organizations to execute clinical strategies and monitor trial deliverables.

• Create and maintain clinical plan timelines and process maps.

• Develop and manage the overall clinical budget and change management process.

• Identify and communicate clinical risks along with mitigation or contingency strategies.

• Supervise clinical trial operations and the achievement of milestones.

• Manage implementation timelines and clinical trial activities efficiently.

• Select and oversee vendors while ensuring operational deliverables are met.

• Address clinical implementation challenges and lead risk assessments and contingency planning.

• Collaborate with regulatory and medical teams on safety management and monitoring protocols.

• Document significant decisions, actions, adjustments, metrics, and clinical information.

• Manage partnerships and engage in governance forums.

• Disseminate information across the organization to facilitate decision-making.

• Collaborate at various organizational levels and work through others in a matrix environment.

• Formulate and assess molecule-level strategies.

• Mentor and provide constructive feedback to colleagues.

• For select positions: recruit, develop, retain, train, coach, mentor, and manage departmental personnel; assist in succession planning, talent assessment, performance evaluation, promotion, workload, and resource management.

⛳️ Requirements

• Bachelor's degree in a science-related field from an accredited institution.

• A minimum of 3 years in the pharmaceutical industry with direct experience managing clinical studies, preferably in exploratory and biopharmaceutics clinical development (5+ years preferred).

• Strong understanding of regulations and guidelines governing clinical trial conduct.

• Ability to influence and oversee Third Party Organizations to ensure the successful delivery of trial level outcomes.

• Proven knowledge and experience with project management tools and methodologies.

• Demonstrated capability to work effectively across cultures and within a virtual work environment.

• Proven ability to appropriately influence both internal and external stakeholders and build strong professional relationships.

• Strong problem-solving abilities; capable of identifying systemic issues, diagnosing root causes, and implementing corrective actions to prevent recurrence within the team.

• Excellent self-management, organizational, and interpersonal skills, with the capacity to adapt in diverse environments and with multiple customer groups.

• Strong leadership and networking capabilities.

• Exceptional oral and written communication skills; able to convey information clearly to team members and leadership.

• Proficient in computer skills; experienced in using Word, Excel, PowerPoint, and Microsoft Project.

• Willingness to travel (up to 10% expected).

• Advanced scientific degree is preferred.

• Experience in exploratory and biopharmaceutics clinical development is preferred.

• Experience in vendor management and contracting.

• Proven track record of coaching and mentoring others.

• Advanced end-user computer skills demonstrated.

🏝️ Benefits

• Opportunity to work in a virtual work environment.

• Willingness to travel (up to 10% expected).