Program Lead, Clinical Delivery

🔥 3 minutes ago

🌐 Brazil, Argentina – Remote

🇧🇷 Brazil – Remote 🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead the creation and execution of exploratory and biopharmaceutics clinical development plans at the molecule level • Provide technical leadership and operational oversight of clinical research trials within the development plan • Plan and deliver clinical trial and submission milestones on time and on budget throughout the molecule lifecycle • Serve as the single operational point of contact for trials from design through execution • Create and manage timelines, outsourcing plans, vendor management, and budgets • Lead development of clinical asset strategies for Phase 1 • Consult on clinical and regulatory documents, including protocols, Investigator Brochures, risk profiles, annual reports, briefing documents, NDAs, safety updates, CSRs, abstracts, publications, and manuscripts • Maintain knowledge of relevant disease states, targets, competitors, industry trends, and best practices • Lead implementation and integration of clinical project management processes and tools • Work with Third Party Organizations to execute clinical strategy and oversee trial deliverables • Develop and maintain clinical plan timelines and process maps • Develop and manage the overall clinical budget and change process • Identify and communicate clinical risks and mitigation or contingency plans • Oversee clinical trial operations and delivery of milestones • Manage implementation timelines and clinical trial activities • Select and manage vendors and oversee operational deliverables • Resolve clinical implementation issues and lead risk assessments and contingency planning • Partner with regulatory and medical teams on safety management and monitoring processes • Document key decisions, actions, modifications, metrics, and clinical information • Manage partnerships and participate in governance forums • Communicate information across the organization to support decision-making • Collaborate across levels and work through others in a matrix environment • Develop and evaluate molecule-level strategies • Coach and provide constructive feedback to coworkers • For select roles: recruit, develop, retain, train, coach, mentor, and manage department personnel; support succession planning, talent assessment, performance, promotion, workload, and resource management

🎯 Requirements

• Bachelor’s degree in a science related field from an accredited college or university • 3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred) • Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials • Ability to influence and oversee TPOs to enable delivery of trial level deliverables • Demonstrated knowledge and experience with project management tools and processes • Demonstrated ability to work effectively cross-culturally and in a virtual work environment • Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships • Demonstrated problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes, and take corrective actions to prevent recurrence within the team • Strong self-management, organizational and interpersonal skills, and the ability to be flexible in varying environments and with multiple customer groups • Strong leadership and networking skills • Excellent oral and written communication skills; able to communicate clearly with and team members and leadership • Strong computer skills; skilled at using Word, Excel, PowerPoint, and Microsoft Project • Ability to travel (up to 10% expected) • Advanced scientific degree preferred • Exploratory and biopharmaceutics clinical development experience preferred • Vendor management and contracting experience • Proven experience of coaching and mentoring others • Demonstrated high-level, end-user computer skills

🏖️ Benefits

• Ability to work in a virtual work environment • Ability to travel (up to 10% expected)