Department: R&D: Clinical
Reports To: Executive management
FLSA Status: Exempt
Location: San Diego or Remote
Reporting directly to the Vice President and Head of Operations, the Sr Director, Program Management (PM) will provide the overall planning, management, and oversight for a cross-functional Development Team. The PM helps design and support program strategies, develops integrated program plans, and schedules, monitors, and tracks team progress. The PM will facilitate team and sub-team meetings associated with assigned projects as well as develop and manage the budget. The PM is a key team member and subject-matter-expert (SME) for program management’s processes, procedures, protocols, and general best practices.
- Manages one or more cross-functional development teams, facilitates and documents project team meetings, driving cross-functional planning and communication, leading risk management planning, and monitoring the program and status of the plan.
- Applies project management expertise, methodologies, and department standards to assist in building a world-class program management function.
- Builds and maintains a positive and dynamic working relationship with the team leader, team members, other internal stakeholders, and vendors.
- Works with various cross-functional colleagues (Nonclinical/Clin Pharm, Clinical Development, Clinical Operations, Regulatory, Biostats, Safety, Tech Ops, and QA) to make the appropriate recommendations to the Program Team for assigned assets.
- Communicates effectively with team members, senior leaders, and key stakeholders on assigned program(s) progress, issues, risks, needs and opportunities.
- Escalates critical issues and relays to leadership with an appropriate plan-of-action to address
- Develops and drives continuous improvements; tracks KPIs and metrics; and implements best practices in support of the advancement of a portfolio of drug candidates.
- Helps develop, maintain, track, and manage high quality, integrated product plans, including clearly identified critical paths and key risks as needed.
- Facilitates and coordinates group/team meetings, ensuring results-oriented meetings and positive team dynamics – including sending out agendas and minutes on a timely basis.
- Models and coaches on high-performing team best practices.
- Contributes to the development of a risk register for the assigned therapeutic indication(s).
- Manages program content buildout for assigned programs, and frequently updates content to the program team collaboration site, including any organizational and productivity tools to help teams stay on target with program deliverables.
- Manages team-level and corporate processes effectively, using strong process and project knowledge to drive team deliverables.
- Helps develop and improve critical business processes, program management tools, templates, and best practices.
- Supports Financial Planning & Analysis in developing, maintaining, tracking, and managing budgets and by identifying budgetary impacts of strategic and critical issues.
- Tracks progress against approved program plans; produces timely and accurate status update reports.
- Other duties as assigned.
- Bachelor’s degree in life science or other relevant field required; advanced degree (e.g., MBA or PhD) is preferred
- A minimum of 15+ years of relevant and progressive drug development experience in the pharmaceutical industry including a minimum of 8+ years of program management experience leading or managing cross functional drug development programs required.
- Significant experience in full-cycle drug development/pharma required, especially Ph 2 – Ph 3 clinical development experience and working knowledge of regulatory requirements for product registration globally.
- Significant to advanced experience using Microsoft Office Suite including Project, Excel, PowerPoint and SharePoint required; experience with Smartsheet is helpful.
- Ability and passion to work in demanding, dynamic, fluid, and fast-paced environment.
- Advanced understanding of program management processes, tools, and techniques; PMP or similar certification highly preferred.
- Clear understanding of the critical path and a drive to find solutions to meet or exceed timelines.
- Demonstrated ability to act/think strategically and see “the big picture”, all the while being hands on by initiating and driving teams for clarity, action, and solutions to move the program forward.
- Demonstrated ability to handle high volumes of work in a fluid, dynamic, stressful, and fast-paced environment.
- Demonstrated ability to lead, mentor and manage others, even if not direct reports/formal authority.
- Demonstrated ability to manage and influence stakeholders, including decision making.
- Demonstrated ability to organize multiple priorities and projects, and to deliver high-quality work according to tight timelines.
- Demonstrates sound judgment and leadership skills.
- Demonstrates strong facilitation and interpersonal skills.
- Detail-oriented with effective problem-solving and troubleshooting skills.
- Process-oriented with the ability to understand complex data and information.
- Travel up to 5% (US and International)