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Biotechnology

Associate Director/Director Project Management

RemoteHybridFull TimeDirector$180,000–$230,000 /yrPosted 19 days ago

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Required skills

  • Clinical Development
  • Clinical Operations
  • Biometrics
  • Regulatory Affairs
  • Safety
  • CMC
  • Medical Affairs
  • Commercial
  • Quality
  • PMP

Nice to have

  • Comparable qualification

Role summary

We are seeking an Associate Director / Director, Project Management to partner strategically with cross-functional drug development teams and enterprise initiatives. This role will drive integrated planning, execution oversight, governance, risk management, and decision support as the company progresses through Phase 3 development, NDA preparation, and commercial launch readiness. Embedded within program teams, you will collaborate with leaders across various departments including Clinical Development, Regulatory Affairs, Commercial, and Quality. The ideal candidate possesses strong project and program management leadership skills, a hands-on approach, and the ability to thrive in a dynamic environment.

Summary

We are seeking an Associate Director / Director, Project Management who will serve as a strategic project management partner for cross-functional drug development program (sub) team(s) and other key enterprise initiatives. The role is responsible for driving integrated planning, execution oversight, governance, risk management and decision support across complex projects as the company advances through Phase 3 development, NDA preparation and commercial launch readiness.
Working within the Project Management & Operational Excellence function, this individual will be embedded within program (sub) teams or strategic enterprise initiatives and will collaborate closely with leaders across Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Safety, CMC, Medical Affairs, Commercial, Quality and Corporate Functions. The successful candidate combines strong project and program management leadership skills with a pragmatic, hands-on approach and the ability to operate effectively in a dynamic environment.

Responsibilities

  • Serve as project manager for one or more development program (sub) teams or strategic corporate initiatives, driving execution against goals and proactively resolving issues that could impact delivery.
  • Develop and maintain integrated cross-functional project plans with clear milestones, dependencies, assumptions and critical paths, ensuring objectives, deliverables and timelines are aligned across functions.
  • Coordinate cross-functional readiness for Phase 3 execution, data readouts, NDA preparation, regulatory interactions and launch planning.
  • Facilitate effective collaboration among internal teams and external partners.
  • Run governance meetings, steering committees and leadership reviews, and maintain action, decision and risk logs.
  • Prepare concise updates, dashboards, risk assessments and decision materials for senior management, escalating critical issues promptly to support informed decision-making.
  • Identify, assess and monitor risks and opportunities, propose mitigation strategies, and support scenario planning and evaluation of strategic alternatives.
  • Partner with functional leaders on resource requirements, constraints and trade-offs, ensuring the impact of changes in scope, timelines or assumptions is understood and communicated.
  • Apply and continuously improve project management standards, tools, and governance, planning and reporting processes, including lessons learned, while avoiding unnecessary bureaucracy.

Required Qualifications & Experience

  • 8-12+ years of experience and Bachelor's degree in Life Sciences, Pharmacy, Medicine, Business or a related discipline. PMP or comparable qualification preferred.
  • Strong knowledge of clinical development processes from Phase 1 through Phase 3 and major regulatory submissions (e.g. IND, NDA, MAA, BLA)..
  • Strong command of integrated planning, critical-path analysis, scenario planning, risk management, governance, budgeting and lifecycle management.
  • Proven leadership of complex global cross-functional teams, with the ability to influence without formal authority in a matrix environment, resolve conflict and manage senior stakeholders.
  • Strong risk management and problem-solving capabilities.
  • Demonstrated judgement, accountability and delivery focus while balancing speed, cost, quality and compliance.
  • Excellent executive communication, facilitation, influencing and decision-support skills.
  • Ability to operate effectively at both strategic and hands-on levels in a dynamic matrix organization.
  • Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
  • Please note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.
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