Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
Rezolute has initiated a global Phase 3 trial for RZ358 as a treatment for congenital hyperinsulinism (cHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
Rezolute will be initiating a global Phase 3 trial for RZ358 as a treatment for tumor hyperinsulinism (tHI), an ultra-rare co-morbidity of insulinomas and some other non-islet cell tumors, characterized by excessive production of insulin or IGF-2 by cancerous tumors.
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 for the cHI program; and will file for breakthrough status on the tHI program.
The Director of Project Management will report to the CFO and 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 own and manage the project timelines, task interdependencies and estimated resource requirements for all major projects within the organization. The Director of Project Management will establish high performance processes and practices throughout the organization; ensure organizational alignment across RZ358’s various clinical programs, CMC program and commercial launch efforts; and drive planning to successfully deliver on program objectives. They 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, as needed. Responsibilities also include day-to-day planning, coordinating and tracking of critical activities, and information flow between team members and across teams.
This position is a hybrid role and is expected to work in our Redwood City, CA office at least 2-3 days per week, with the option to work remotely a few days per week. Working in the office setting will allow for regular engagement with key staff members, including executive management (i.e., the CEO, CFO, CMO and others).
Responsibilities Include:
- Manage the project management timelines in collaboration with colleagues and the leadership team.
- Support the planning of strategies and goals for clinical programs/projects in close collaboration with key stakeholders; establish alignment at all levels of the organization and across projects to optimize execution.
- Support cross-functional program/project teams to help effectively define and manage deliverables and timelines, facilitate decision making, and outline risk mitigation strategies.
- Maintain the integrated project timelines, risk registers and associated project management tools for each program. Work with project teams to ensure accuracy and completeness, communicate project status to all external stakeholders and maintain effective communication within project team through oral and written correspondence.
- Proactively, and independently, identify and resolve project team challenges. Drive scenario planning in support of strategic decision making.
- Review and revise project work plans to accommodate changes in technical, marketing, or business objectives and communicate changes accordingly.
- Work with project team to define program-related budget assumptions for annual operating plan.
- Demonstrate problem solving and good judgment in which analysis of situations or data requires an in-depth evaluation of various factors.
- Develop knowledge of current therapeutic environment and drug development trends as needed.
- Participate in work related professional organizations and represent the Company in appropriate professional public forums. Integrates scientific and business objectives to maximize program success.
Candidate Profile
Qualifications/Requirements:
- Minimum of a BA/BS in a scientific discipline is required, while an advanced degree is desirable in a discipline related to drug development.
- Certification in Project Management is preferred.
- Continuing education in Project Management best practices is required.
- A minimum of 7 years of experience in the Pharmaceutical, Medical Products or other related industry is required, with a strong preference for experience as a project manager in a biologics-based drug development capacity.
- A minimum of 4 years of formal project management experience.
- Prior experience in managing interdisciplinary or cross-functional pharmaceutical or medical device product development teams is required. Ability to drive project plan and timelines (across multiple functional areas) essential.
- Prior experience in managing cross-functional teams through late-stage clinical and regulatory projects and related key milestones is required. Specifically, experience in driving teams to BLA/MAA filings is strongly preferred.
- 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.
- Good computer skills are required, with a strong knowledge of the MS office suite, SharePoint and MS Project, SmartSheet or other standard project management software is required.
- Ability to relate and work with a wide range of people (internal and external) to achieve results.
- 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 in a hybrid-remote context, with an instinctive understanding of when to escalate or seek assistance from others.
- Familiarity with developing budgets and forecasting desirable.
- Keen insight, independent judgment and tactful discretion are required.
- 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.
Rezolute (RZLT) currently anticipates the base salary for the Director of Project Management role could range from $210,000 to $225,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
Qualifying employees are eligible to participate in benefit programs such as:
- Health Insurance (Medical / Dental / Vision)
- Holiday Pay
- Tracking Free Vacation Program
- Educational Assistance Benefit
- Fitness Center Reimbursement
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
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