Project Manager

Jobtailor; Thousand Oaks (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Jobtailor is seeking a seasoned Drug Development Program Manager in Thousand Oaks, CA to own integrated program plans across regulatory, clinical, CMC/supply, quality, and commercial streams. You will drive timelines from NDA to launch and coordinate with functional leaders to resolve issues.

You will monitor schedules, budgets, and resources, develop strategy with program teams, maintain current plans, and communicate risks along with mitigation plans. Excellent communication is essential.

Qualifications

• BA/BS or higher in life sciences or related field.
• Minimum six years' experience in Biotechnology, Pharmaceutical, or Healthcare.
• Minimum three years in direct drug development project management.
• Strong understanding of drug development and commercialization.
• Proficient in project management principles and tools like SmartSheet and Excel.
• Ability to manage multiple tasks in a fast-paced environment with minimal oversight.
• Demonstrated ability to influence without authority and communicate clearly.

Responsibilities

• Own 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 functional management to resolve program or resource issues.
• Monitor and manage program progress, schedules, resources, and deliverables.
• Collaborate with program teams to develop strategy and identify key program goals.
• Ensure program plans remain current and aligned with strategic shifts.
• Evaluate and communicate risks, risk-management plans, and their impact on overall program plans.
• Serve as the program team's single source of truth by converting meeting discussions into concise, decision- and action-oriented minutes.
• Drive timely information flow and capture accessible institutional knowledge.
• Support program budget development, tracking, and variance management.
• Challenge teams with disconfirming information and encourage innovative problem-solving.

Skills

Drug development project management

Program planning

Risk evaluation

Interpersonal communication

Influencing without authority

Written and verbal communication

Education

Bachelor's degree in life sciences

Tools

SmartSheet

Excel

Job description

Responsibilities

• Own 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 functional management to identify and resolve program or resource issues
• Monitor and manage program progress, schedules, resources, and deliverables
• Collaborate with program teams to develop strategy and identify key program goals
• Ensure program plans remain current and aligned with strategic shifts
• Evaluate and communicate risks, risk-management plans, and their impact on overall program plans
• Serve as the program team's single source of truth by converting meeting discussions into concise, decision- and action-oriented minutes
• Drive timely information flow and capture accessible institutional knowledge
• Support program budget development, tracking, and variance management
• Challenge teams with disconfirming information and encourage innovative problem-solving

Requirements

• 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
• 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
• Ability 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

Core Competencies

Demonstrates expertise in drug development project management, including program planning, risk evaluation, and resource management. Proficient in utilizing project management tools to drive program success within the Biotechnology and Pharmaceutical sectors.

Highest-signal resume keywords

• Drug Development Project Management
• Program Planning
• Risk Evaluation
• SmartSheet Proficiency
• Interpersonal Communication

Hard Skills

• Project Management Principles
• Drug Development
• Commercialization
• Program Budget Development
• Resource Management
• Timeline Management
• Risk Management
• Decision-Making
• Scenario-Based Planning
• Variance Management

Soft Skills

• Organizational Skills
• Influencing Without Authority
• Problem-Solving
• Written Communication
• Verbal Communication

Industry Keywords

• Biotechnology
• Pharmaceutical
• Healthcare
• NDA Submission
• PDUFA
• Clinical Development
• Nonclinical Development
• CMC/Supply
• Quality Management
• Commercial Workstreams

Tools & Technologies

• SmartSheet
• Excel