Director, Program and Alliance Management

Role Overview:

This role is based in San Diego. The Director, Program and Alliance Management will be responsible for coordinating activities to support our client’s clinical pipeline programs as well as those preparing for IND submission.  The Director of Program and Alliance Management will contribute to strategic planning and lead implementation of activities across multiple clinical and preclinical functional groups to deliver on the strategic priorities of the Clinical Development group.  This position will report to the Chief Medical Officer.

Key Responsibilities:

• Contribute to strategic planning for clinical stage and IND-ready pipeline programs.
• Lead, drive, coordinate and track IND submission, clinical studies, and activities across internal functional groups and with external vendors/consultants.
• Develop, maintain, and manage high-quality detailed study timelines; interface regularly with project teams and cross-functional stakeholders to ensure key activities are well-coordinated and accurately reflected on the study- and program timelines, and align with corporate and program goals.
• Prospectively identify timeline risks, proactively communicate risks to management, internal and external stakeholders, and coordinate development and implementation of risk mitigation strategies to facilitate efficient, on-time execution of studies.
• Effectively partner with R&D Scientific Team Leads and Development Teams to drive projects and programs to successful outcomes
• Develop and drive project plans and timelines; track and manage milestones within the defined scope, time, and cost constraints; support coordination and communication between teams, ensuring senior leaders are frequently informed on project progress
• Manage routine status reporting including study timeline and budget dashboards and management updates.
• Provide monthly milestone and timeline updates.
• Work with study managers to collect and analyze forecasted and accrued costs to produce at-a-glance data displays summarizing project financial status.
• Coordinate KOL/MD interactions at ad boards and in 1:1’s.
• Lead and build out program and project management functions as appropriate based on growing needs of pipeline programs
• Lead and manage relationships and programs with client’s external partners based on a thorough knowledge and understanding of the collaboration agreements the collaborative scientific activities and the research goals
• Primary point of contact for partner organizations, driving and/or assisting in the review and all partner communications and ensuring client’s compliance with the collaboration agreement terms
• Monitoring and tracking partnership progress, ensuring timely achievement of milestones and contractual obligations

Qualifications/Experience:

• Bachelor’s degree in related discipline.
• Typically, 10 to 15 years in pharmaceutical/biotechnology industry, including 5+ years in project management in early-stage discovery; alliance management experience preferred.
• Experience submitting INDs and managing clinical programs, knowledge of cross functional groups including clinical research, regulatory sciences, translational medicine, CMC, biometrics, safety, toxicology, and DMPK.
• Strong influencing skills including negotiation, meetings management, and group dynamics, ability to balance concerns of senior leaders with objectives of cross-functional teams.
• Experience evaluating, selecting, and managing external vendors to support clinical programs.
• Solid understanding of drug development strategy and clinical operations.
• Familiarity with FDA and EMA regulatory requirements, Good Clinical Practice (GCP), and clinical trial processes.
• Experience building infrastructure and managing teams.
• Experience working on clinical stage oncology programs is preferred
• Excellent organizational and time management skills with strong attention to detail, and proven ability to handle multiple tasks efficiently and effectively.
• Excellent communication skills, with the ability to represent program and corporate messaging to external parties.
• Familiarity with project management software, and Microsoft Office.