Executive Director, Program Management - Pharmaceutical
Description
Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.
We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.
Position Summary:
The Executive Director, Program Management will work closely with product teams and R&D functions to translate asset strategy into integrated development plans and drive execution of key program objectives. Working closely with the product team members across non-clinical development, clinical development/science, clinical operations, regulatory, medical writing and biometrics, this role will guide strategic planning, manage timelines and interdependencies, identify and mitigate risks, integrate project plans, and facilitate timely decision-making. This role will report to the Vice President, Asset Strategy.
This is a hybrid role (2-3 days a week) at our Newark, CA office. We will only consider local candidates at this time.
Responsibilities:
- Lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, and identification of resource constraints, ensuring appropriate escalation
- Partner with R&D functions and manage overlapping timelines and interdependent deliverables to ensure timely execution of clinical operations activities and regulatory submissions.
- Support Product Team meetings and discussions using meeting management best practices to drive, scenario planning, cross-functional communication, decision-making, and execution of program objectives
- Develop agendas and summarize key meeting discussions and decisions, including providing program updates and recommendations to senior leadership
- Develop, track and maintain project development timelines (integrated project plans), project deliverables and milestones
- Provide project management guidance by communicating interdependencies, critical path activities, and alignment with corporate goals
- Work closely with and build strong working relationships with cross-functional team members and external vendors to develop a collaborative team environment.
- Lead scenario planning to evaluate development options and their implications for timelines, costs, resources, and program risk
- Establish and improve program management practices, tools, and reporting to strengthen execution across the development portfolio
Qualifications:
- Bachelor’s degree with 15+ years of project management experience in drug development, or equivalent experience
- Strong understanding of Drug Development process and US and ex-US regulatory requirements, including demonstrated NDA/BLA submissions experience
- Essential experience in early-stage programs (pre-clinical through Phase I/II) and late-stage program development (Phase II/III pivotal)
- Proven project management leadership with ability to drive complex programs with alignment from the cross-functional teams to meet business needs
- Proven ability to balance the strategic needs of the program with tactical day-to-day activities
- Excellent communication and interpersonal skills, including conflict resolution, diplomacy, and the ability to influence others
- Highly collaborative team player who promotes open communication and responds effectively to urgent needs
- Proven ability to develop and manage accurate integrated project plans and timelines, with proficiency in Microsoft Project, PowerPoint, and Excel
- PMP certification preferred
Disclaimer
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.