Program Lead, Clinical Delivery

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

📋 Description

• Lead the development and execution of exploratory and biopharmaceutics clinical development plans at the molecular level.

• Provide technical guidance and operational oversight for clinical research trials.

• Plan and ensure clinical trial and submission milestones are met on schedule and within budget throughout the molecule lifecycle.

• Supervise global clinical trial operations from design to execution.

• Create and manage timelines, outsourcing strategies, vendor relations, operational outputs, and financial plans.

• Offer scientific and therapeutic-area expertise for Phase 1 clinical asset strategies.

• Advise on protocols, Investigator Brochures, risk assessments, annual reports, briefing documents, NDAs, safety updates, CSRs, abstracts, publications, and manuscripts.

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

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

• Maintain clinical plan timelines and process maps, and communicate progress to the molecule team.

• Develop and manage the overall clinical budget and change-control process.

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

• Oversee clinical trial operations and the achievement of project milestones.

• Select and manage vendors while ensuring their operational deliverables are met.

• Act as the global clinical team contact for implementation issues, risk assessments, contingency planning, and communication.

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

• Document decisions, actions, scope, resources, timelines, and clinical metrics; ensure proper archiving.

• Manage partnerships and integration with the clinical team, including governance forums.

• Communicate information across different organizational levels to facilitate decision-making.

• Collaborate within a matrix organization and deliver results through others.

• Coach and provide constructive feedback to team members.

• For select roles: recruit, develop, retain, train, mentor, and manage department staff; support talent, succession, performance, workload, and resource planning.

⛳️ Requirements

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

• Minimum of 3 years of experience in the pharmaceutical industry with direct management of clinical studies; 5+ years preferred.

• Strong understanding of regulations and guidelines applicable to clinical trial conduct.

• Capability to influence and oversee Third Party Organizations (TPOs) to ensure delivery of trial-level outputs.

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

• Demonstrated ability to work efficiently across cultures and in a virtual work environment.

• Proven ability to influence both internal and external environments and build strong working relationships.

• Strong problem-solving skills, including root-cause analysis and corrective action implementation.

• Excellent self-management, organizational, interpersonal, leadership, and networking abilities.

• Adaptability to varied environments and multiple customer groups.

• Exceptional oral and written communication skills.

• Strong computer proficiency; adept in Word, Excel, PowerPoint, and Microsoft Project.

• Willingness to travel, up to 10% of the time.

• Advanced scientific degree preferred.

• Experience in exploratory and biopharmaceutics clinical development preferred.

• Experience in vendor management and contracting.

• Proven track record of coaching and mentoring others.

• Demonstrated high-level end-user computer skills.

🏝️ Benefits

• No specific benefits, perks, or compensation extras are stated in the posting.