Head of Program Management
Location: Redwood City, CA
- Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (Congenital HI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
- The company’s second clinical-stage asset, currently in Phase 1, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
- Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com
The Head of Program Management will report to the CEO and will work in collaboration with numerous functions at all levels of the organization. This person will be a highly strategic partner to the executive team providing strong leadership and expertise to optimize program management at company. This role is responsible for developing and leading the Program Management function while leading the planning and supporting the execution of all development programs at the company, including two ongoing clinical trials. S/he will establish high performance processes and practices throughout the organization, ensure organizational alignment across RZ358 and RZ402, and drive planning and execution to successfully deliver on program objectives. S/he will also develop insights into strategic and execution risks, surface pivotal questions for the executive team, and recommend critical investments in capabilities, human capital and infrastructure. Responsibilities also include day-to-day planning, coordinating and tracking of critical activities and information flow between team members, as well as driving project timelines to keep the project on schedule and within budget and scope.
- Develop the Program Management function, processes, roles, and responsibilities in collaboration with colleagues and the leadership team.
- Shape the strategy, goals and plans for clinical programs/projects in close collaboration with key stakeholders; establish alignment at all levels of the organization and across projects to optimize execution.
- Institute, and, as appropriate, lead, cross-functional program/project teams that effectively define and manage deliverables and timelines, facilitate decision making, and outline risk mitigation strategies.
- Proactively, and independently, identifies and resolves project team challenges. Drives scenario planning in support of strategic decision making.
- Directs cross-functional project team(s) and drives information compilation and information flow. Communicates project status to all stakeholders.
- Works with project team to define program-related budget assumptions for annual operating plan.
- Maintains effective communication within project team through oral and written correspondence.
- Demonstrates problem solving and good judgment in which analysis of situations or data requires an in-depth evaluation of various factors.
- Develops knowledge of current therapeutic environment and drug development trends as needed.
- This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
- Ensures that resources assigned to the program are adequate to meet program objectives and identifies resource constraints.
- Makes recommendations as to whether program or project activities should be outsourced for greater resource efficiency.
- Reviews and revises project work plans to accommodate changes in technical, marketing, or business objectives and communicates changes accordingly.
- Participates in work related professional organizations and represents the Company in appropriate professional public forums.
- Integrates scientific and business objectives to maximize program success.
- Other Duties as assigned.
- Minimum of a BA/BS in a scientific discipline is required, while an advanced degree (PharmD, PhD, MS, MBA, MD) is desirable in a discipline related to drug development or business.
- Certification in Project Management is preferred.
- Continuing education in Project Management best practices is required.
- A minimum of 10 years of experience in the Pharmaceutical, Medical Products or other related industry is required.
- A minimum of 8 years management experience is preferred.
- Prior experience in managing interdisciplinary or cross functional pharmaceutical or medical device product development teams is required.
- Prior experience in managing cross-functional teams through strategic Regulatory plans and related key milestones is required.
- Specifically, experience in driving teams to BLA/MAA filings is strongly preferred.
- Previous experience working with corporate partners or acting as a liaison is required.
- Understanding of FDA regulatory processes and prior experience with regulatory filings is highly desired.
- Participation in an executive steering committee for pharmaceutical or medical device product development is required.
- A working knowledge of basic financial accounting is required.
- Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint and Project is required.
- Demonstrated ability to develop, manage and lead cross-functional teams.
- Ability to relate and work with wide range of people (internal and external) to achieve results.
- Ability to drive project plan and timelines (across multiple functional areas) essential.
- Proven success in goal setting, prioritization and time management.
- Proactive individual with strong leadership, facilitation, teamwork and influence management/negotiation skills.
- Proven ability to proactively identify risks and drive resolution of issues.
- Ability to work independently for decision-making and resolution of project obstacles and conflicts.
- Familiarity with developing budgets and forecasting desirable.
- Keen insight, independent judgment and tactful discretion are required.
- Business acumen a big plus.
- Ability to deal with ambiguity. Self-motivated, flexible and resilient.
- Commitment to professional development of oneself, team members and department.
- Must be able to demonstrate strong analytical and problem-solving capabilities.
- Excellent oral and written communication skills are required.
- Must be able to demonstrate strong organizational skills.
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Melissa Quinn.