Director, Program Management Full Life Cycle IND to Phase II
Monte Rosa Therapeutics
June 29, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Responsibilities:
- Serve as 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 to evaluate development pathways, indication sequencing, acceleration opportunities, and capital-efficient trade-offs.
- Pressure-test timelines and critical paths; streamline execution without compromising quality.
- Establish proactive risk identification and mitigation frameworks (biomarker risk, patient heterogeneity, regulatory complexity, competitive shifts).
- Lead Global Program Team risk discussions and timely escalation of high-impact issues.
- Develop contingency strategies for clinical, manufacturing, or regulatory inflection points.
- Monitor program-level budget and resource health; ensure functional accountabilities and decision rights in a lean, matrixed structure.
- Partner in long-range planning and portfolio prioritization.
- Build real-time tracking tools (e.g., dashboards, integrated timelines, risk logs) and prepare executive-ready materials.
- Lead continuous improvement initiatives in Program Management.
Qualifications:
- 12+ years in biotechnology/pharmaceutical drug development.
- Minimum 8 years program/project management leading cross-functional teams.
- Experience advancing immunology/inflammation assets through Phase 2 and Phase 3.
- Experience supporting major regulatory interactions (e.g., End-of-Phase 2 meetings, NDA/BLA).
- Experience in small-to-mid-sized biotech environments.
Education/Skills:
- BS required; MS/PhD/MBA strongly preferred; PMP desirable but not required.
- Strong understanding of immunology/inflammation biology, clinical endpoints, biomarker strategy, and regulatory considerations.
- Expertise in end-to-end development, integrated planning, risk management, scenario modeling; ability to lead through ambiguity.
- Proficiency with Smartsheet, MS Project, Teams; strong executive communication, organization, and conflict resolution.
Compensation: $150,000–$225,000 salary per year.
Application: Apply online with CV and cover letter in one document via the career portal.
- Serve as 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 to evaluate development pathways, indication sequencing, acceleration opportunities, and capital-efficient trade-offs.
- Pressure-test timelines and critical paths; streamline execution without compromising quality.
- Establish proactive risk identification and mitigation frameworks (biomarker risk, patient heterogeneity, regulatory complexity, competitive shifts).
- Lead Global Program Team risk discussions and timely escalation of high-impact issues.
- Develop contingency strategies for clinical, manufacturing, or regulatory inflection points.
- Monitor program-level budget and resource health; ensure functional accountabilities and decision rights in a lean, matrixed structure.
- Partner in long-range planning and portfolio prioritization.
- Build real-time tracking tools (e.g., dashboards, integrated timelines, risk logs) and prepare executive-ready materials.
- Lead continuous improvement initiatives in Program Management.
Qualifications:
- 12+ years in biotechnology/pharmaceutical drug development.
- Minimum 8 years program/project management leading cross-functional teams.
- Experience advancing immunology/inflammation assets through Phase 2 and Phase 3.
- Experience supporting major regulatory interactions (e.g., End-of-Phase 2 meetings, NDA/BLA).
- Experience in small-to-mid-sized biotech environments.
Education/Skills:
- BS required; MS/PhD/MBA strongly preferred; PMP desirable but not required.
- Strong understanding of immunology/inflammation biology, clinical endpoints, biomarker strategy, and regulatory considerations.
- Expertise in end-to-end development, integrated planning, risk management, scenario modeling; ability to lead through ambiguity.
- Proficiency with Smartsheet, MS Project, Teams; strong executive communication, organization, and conflict resolution.
Compensation: $150,000–$225,000 salary per year.
Application: Apply online with CV and cover letter in one document via the career portal.