Director – Program Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the operational leader for the cross-functional program team.

• Ensure strategic alignment, timelines, resources, risks, and governance across Clinical Development, Regulatory, CMC, Biometrics, Medical Affairs, Commercial, Quality, and Corporate functions.

• Promote cross-functional cooperation and facilitate operational excellence within Clinical Development, Regulatory Affairs, and CMC.

• Guarantee timely achievement of program milestones.

• Create and maintain integrated timelines that outline critical paths, regulatory submissions, and clinical milestones.

• Drive accountability and communicate with the broader organization to support prompt decision-making, risk management, and mitigation strategies.

• Balance strategic vision with disciplined execution to advance programs through development and regulatory approval.

• Implement best practices, tools, and governance processes for program management.

• Lead continuous improvement initiatives in development operations.

• Standardize planning methodologies, reporting, and metrics.

• Advocate for operational discipline across cross-functional teams.

• Report directly to the Vice President of Program Management.

⛳️ Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, or a related discipline is required; Ph.D., MS, or MBA is preferred.

• 12+ years of experience in the biotechnology or pharmaceutical industry.

• At least 7+ years of experience in oncology or hematology drug development.

• A minimum of 7+ years specifically focused on dedicated program or project management.

• Familiarity with tyrosine kinase inhibitors (TKIs) or hematologic malignancies is highly desirable.

• Strong preference for experience in supporting NDA/BLA/MAA regulatory submissions.

• Preferred experience within a clinical-stage biotechnology company.

• In-depth understanding of FDA/EMA regulations, CMC, and the phases of clinical trials.

• Advanced proficiency in Smartsheet or similar enterprise planning tools.

• PMP certification is a significant advantage.

• Proven ability to align cross-functional teams, resolve conflicts, and facilitate decision-making.

• Capacity to work 40 hours per week; occasional evening, weekend, holiday, and on-call work may be required.

• Anticipated travel of approximately 30% may be necessary.

• Successful completion of a background screening is required for employment.

🏝️ Benefits

• Bonus and equity opportunities may be available.

• Full-time remote work arrangement.

• Commitment to equal opportunity employment.

• Background screening process for employment offers.