Overview
The Associate Director of Program Management will serve as a strategic and operational leader for priority immunology and inflammation programs, driving assets from mid- to late-stage development through regulatory submission. This role is designed for a hands-on, agile leader who thrives in a fast-paced biotechnology environment and can rapidly translate evolving science into executable development strategy.
As a core member of the Program Team, the Director will partner closely with Clinical, Regulatory, CMC, Nonclinical, Biomarkers, Translational Sciences, and Commercial leaders to integrate strategy and execution across the full development lifecycle. This individual will ensure alignment to the Target Product Profile (TPP) and Integrated Development Plan (IDP), while enabling flexibility as data emerge and scientific understanding evolves.
Success in this role requires deep familiarity with immunology and inflammation drug development, comfort operating amid uncertainty, and the ability to balance scientific rigor with speed, capital efficiency, and enterprise priorities.
Responsibilities
- Serve as a strategic and operational lead for one or more immunology/inflammation programs, ensuring alignment between clinical strategy, translational insights, and regulatory pathways.
- Develop and maintain integrated, cross-functional development plans across clinical, regulatory, CMC, manufacturing, and translational functions.
- Lead scenario planning exercises to evaluate alternative development pathways, indication sequencing, acceleration opportunities, and capital-efficient trade-offs.
- Continuously pressure-test timelines and critical paths, proactively identifying opportunities to streamline execution without compromising quality.
- Establish proactive risk identification and mitigation frameworks tailored to immunology/inflammation programs, including biomarker risk, patient heterogeneity, regulatory complexity, and competitive landscape shifts.
- Lead high-quality risk discussions at the Global Program Team level with timely escalation of high-impact issues.
- Develop contingency strategies for clinical, manufacturing, or regulatory inflection points.
- Monitor program-level budget and resource health in alignment with corporate priorities.
- Ensure clarity of functional accountabilities and decision rights in a lean, matrixed biotech structure.
- Partner with functional leaders during long-range planning and portfolio prioritization exercises.
- Build and maintain practical, real-time tracking tools (e.g., Smartsheet dashboards, integrated timelines, risk logs) that enable rapid visibility and decision-making.
- Prepare concise, executive-ready materials that distill complex scientific and operational issues into clear recommendations.
- Lead continuous improvement initiatives within Program Management to enhance agility, transparency, and execution discipline.
Qualifications
- 12+ years of experience in biotechnology or pharmaceutical drug development.• Minimum 8 years of program/project management experience leading cross-functional development teams.• Demonstrated experience advancing immunology and/or inflammation assets through Phase 2 and Phase 3 development.• Experience preparing for and supporting major regulatory interactions (e.g., End-of-Phase 2 meetings, NDA/BLA submissions).• Experience operating in small-to-mid-sized biotech environments where agility and hands-on leadership are required.
Education
- BS required; advanced degree (MS, PhD, or MBA) strongly preferred.• PMP certification desirable but not required.
Technical & Leadership Capabilities
- Strong understanding of immunology and inflammation biology, clinical endpoints, biomarker strategy, and regulatory considerations.• Deep knowledge of end-to-end drug development within a resource-conscious biotech setting.• Demonstrated ability to lead through ambiguity and adapt strategy as data emerge.• Proven success influencing senior stakeholders in a highly matrixed environment.• Expertise in integrated planning, risk management, and scenario modeling.• Strong executive presence with the ability to communicate complex scientific and operational topics clearly and concisely.• Proficiency with modern project management and collaboration tools (e.g., Smartsheet, MS Project, Teams).• Exceptional organizational skills with the ability to manage multiple interdependent workstreams simultaneously.• High emotional intelligence, strong conflict resolution skills, and the ability to build trust across scientific and operational teams.• Comfort operating with urgency, limited infrastructure, and evolving priorities typical of innovative biotech companies.