Job: Project Manager
Location:Thousand Oaks, CA or San Francisco CA
Position type: Full Time
Reports to: ED, Acute Program Lead
Position Summary
Latigo is seeking a Manager of Program Management to work closely with the Acute Program Lead and serve as the operational backbone of the acute pain program team as the asset advances toward NDA submission and U.S. launch. This role drives the development and execution of cross-functional program plans that enable the overall program strategy, coordinating regulatory, nonclinical, clinical, CMC/supply, quality, and commercial workstreams across the path to filing and the pre-launch build. Scientific competency and drug development knowledge are essential to interact with cross-functional stakeholders, contribute to development strategy, and translate that strategy into execution. The successful candidate will bring a solution-oriented attitude, a sharp eye for detail, and a willingness to learn in a team environment.
Primary responsibilities include (but are not limited to):
- Accountable for the integrated program plan and timelines across regulatory, nonclinical, clinical, CMC/supply, quality, and commercial workstreams; maintain scenario-based critical-path timelines from NDA submission through PDUFA and launch.
- Drive decision-making and coordinate with the team or functional management to identify and resolve program or resource issues; monitor and manage program progress, schedules, and resources to meet or exceed program goals.
- Collaborate with program teams to develop strategy, and
identify key program goals.
- Monitor and manage program progress, schedules and resources to meet or exceed program goals.
- Ensure program plans are current and in alignment with any strategic shifts.
- Evaluate and communicate the probability and impact of risks, risk management plans and ensure integration into the overall program plans for monitoring deliverables.
- Serve as the program team's single source of truth - convert meeting discussions into concise, decision- and action-oriented minutes and drive timely information flow so stakeholders and leadership stay aligned and institutional knowledge is captured and accessible.
- Support program budget development, tracking and variance management.
- As necessary, challenge teams by providing disconfirming information and encourage innovative problem- solving.
Basic qualifications:
- B.A. degree or higher in life sciences or related disciplines.
- Minimum six (6) years' experience within the Biotechnology, Pharmaceutical, or other Healthcare related field, with minimum three (3) years in direct drug development project management.
- Solid understanding of all aspects of drug development and commercialization.
- Proficient in project management principles and tools such as SmartSheet and Excel.
- Self-motivated and highly flexible individual who is able to manage multiple tasks, and priorities within a fast-paced environment with minimal oversight.
- Demonstrated ability to influence without authority.
- Excellent interpersonal, organizational, written and verbal communication skills.
