Executive Director / VP Program Management
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets, including two novel humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.
The Executive Director/Vice-President of Program Management will work closely with multi-functional development project teams (US and China) to support regulatory submissions from IND to NDA, and on planned and active preclinical and clinical studies to create drive execution of, and track detailed project timelines, budgets, and deliverables.
This will include:
- Working in partnership with project and clinical study teams to ensure timely, efficient, and effective meetings to ensure adequate progress on team activities; and document/track rationale behind key decisions.
- Provide oversight of data exchange with partners with whom we share compound rights.
- Assemble comprehensive Gantt charts including specific resource allocation (person responsible) for all pre-clinical and clinical stage programs integrating cross functional activities to validate the project plans. Review Gantt charts with team members on a regular basis to update, provide reminders, identify critical path items, develop action plans to solve critical issues, and elevate specific concern to senior management.
- Keep project team, senior management, and strategic/co-development partners informed on progress to goals, as well as communicating issues and risks, and proposing and implementing plans to resolve such issues and execute corrective actions.
- Contribute to team strategy and operational logistics, including developing, reviewing critical documents, and vendor management, in order to ensure they are in line with project goals and objectives. Identify program related risks and work with team to develop mitigation path.
- Manage program wide communication of goals, progress, critical issues; provide formal information briefings on project status to team members, function heads, senior management, and alliance partners.
- Actively collaborates with internal stakeholders and partners to establish a governance structure (JDC) and ensure appropriate communication, operational alignment, and success.
- Ensure contract compliance and day-to-day management of the alliance.
- Work with internal matrix and alliance partner to ensure alliance success in terms of milestones and strategic initiatives.
- Partner with Apollomics and business partner senior management/communications colleagues to ensure alignment on US and China public communications.
- Build the Project Management function commensurate with organizational growth.
- Provide project management skills to add value to each cross-functional project by ensuring excellent communication and clear direction of objectives, milestones, and timelines in cross-border internal teams (US and China) and with external stakeholders.
- Ensure bridging and integrating tasks and processes with clinical development activities and Business Development as well as, CMC, preclinical, clinical pharmacology, translational medicine, biometrics, Quality Assurance, Regulatory Affairs, and Pharmacovigilance.
- Lead project team meetings to proactively identify, manage, and quickly resolve issues and problems.
- Collaborate closely with each functional area to ensure projects are moving effectively toward their milestones. Contributes to the creation of clinical development and PM budgets, study budgets, and resource estimates for each functional area.
- Inform senior management of operational, budgetary, or resource issues/obstacles in a timely fashion.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Extensive experience in project management in a drug development environment and has successfully advanced a drug product from research through clinical trials (pre-IND, IND, Ph I, II, III, NDA), and commercialization.
- Minimum of a Master’s degree in life sciences or related field with 10 or more years in the biopharmaceutical industry in project management roles. Advanced degree (PhD, PharmD) is preferred as is a PMP certificate.
- Strong organizational, management, teamwork, interpersonal skills, and professionalism required.
- Excellent clinical and scientific judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Outstanding communication skills (verbal and written). Reading and writing Chinese is a plus.
- Collaborate effectively with the study team, cross-functional team members, and external partners.
- Attention to detail and ability to organize and prioritize tasks in a timely and accurate manner with the big picture in mind.
- Ability to work and manage multiple projects collaboratively in a fast-paced dynamic environment.
- Understanding of the pharmaceutical culture and the special requirements of completing projects within a regulated environment.
- Proficient with Windows: MS Office – Word, PowerPoint, Excel, Project, and ability to learn new programs as needed.