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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in biotechnology or pharmaceutical drug development, with a strong focus on program management across clinical, regulatory, and CMC workstreams. Proficient in utilizing AI tools and automation to enhance program planning and execution.
Highest-signal resume keywords
Biotechnology Or Pharmaceutical Drug Development ExperienceProgram Or Project Management On Clinical-Stage ProgramsCross-Functional Development Plan ManagementAI Tools Fluency And Workflow AutomationStrong Written And Verbal Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Integrated Development Plan ManagementProgram Budget ManagementDrug Development Lifecycle KnowledgePhase 3 ExperienceRegulatory Submissions KnowledgeRisk Management And MitigationScenario Analysis And Forward PlanningClinical Operations IntegrationDecision Framework ImplementationCross-Functional Team Facilitation
Soft Skills
LeadershipCollaborationCommunicationProblem-SolvingDecision-Making
Tools & Technologies
SmartsheetMicrosoft 365AI ToolsLow-Code AutomationBI Platforms
Certifications & Qualifications
PMP CertificationAdvanced Degree In Life Sciences Or Business
Industry Keywords
IND/CTA SubmissionsGlobal Health Authority InteractionsCo-Development PartnershipsClinical-Stage OrganizationLean Operations
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Translate the CLYM116 Integrated Development Plan into an integrated program timeline and own it end to end
- Build and maintain the detailed schedule, interdependencies, critical path, and resourcing across all functions
- Lead day-to-day execution in partnership with the Program Leader
- Maintain a shared, current view of program commitments and status from regulatory interactions and clinical studies through registrational development and launch readiness
- Prepare regular program updates for leadership and materials supporting Board presentations
- Lead forward planning and scenario analysis covering timeline, enrollment, study design, and investment options
- Manage program-level risks, issues, and dependencies; drive mitigation and contingency plans
- Run the program team operating rhythm, including agendas, pre-reads, decision and action logs, minutes, and follow-through
- Implement program governance processes, decision frameworks, and accountability mechanisms
- Integrate study-level plans and status from Clinical Operations into the program plan
- Align workstream plans and dependencies with CMC, Regulatory, and Nonclinical
- Coordinate joint governance with the development partner, including JSC, JDC, and working groups
- Track partner actions, contract milestones, and deliverables, and surface issues early
- Contribute to annual and long-range planning inputs with functional leaders and Finance
- Use AI tools, automation, and integrated systems such as Smartsheet and Microsoft 365 to streamline planning, reporting, and communication
- Build reusable templates, dashboards, and workflows that scale across programs
- Lead or support cross-functional initiatives such as portfolio planning, process improvement, and shared program management tools
Requirements
What you’ll need- 8+ years of biotechnology or pharmaceutical drug development experience (10+ for Director)
- 5+ years of program or project management on clinical-stage programs (7+ for Director)
- Demonstrated drug development experience from pre-IND through Phase 2
- Experience managing an integrated, cross-functional development plan across clinical, regulatory, CMC, and nonclinical workstreams
- Proven ability to facilitate a cross-functional matrix team to decisions and drive delivery without direct reporting authority
- Working knowledge of program budgets and experience partnering with Finance on spend tracking and planning inputs
- Hands-on fluency with AI tools and ability to build AI-enabled ways of working
- Excellent written and verbal communication skills, including preparing materials for executive audiences
- Bachelor's degree in life sciences, business, or a related field
- Phase 3 experience strongly preferred
- Advanced degree or PMP certification preferred
- Experience supporting a program through Phase 3 start-up, registration, or launch readiness preferred
- Strong working knowledge of the drug development lifecycle, including IND/CTA submissions, global health authority interactions, major regulatory submissions, and transition to registrational studies
- Experience supporting a co-development, licensing, or collaboration partnership preferred
- Experience building and scaling AI-enabled workflows preferred
- Experience with low-code automation, APIs and data integration, or BI platforms preferred
- Experience operating in a lean, clinical-stage organization preferred
Benefits
Comp & perks- Discretionary annual bonus
- Medical, Dental and Vision benefits
- Life & Disability benefits
- 401k company match
- Generous paid time off
- Equity
