Associate Director/Director, Program Management (Drug Development)
HotSpot Therapeutics, Inc, Boston, MA, United States
Associate Director/Director, Program Management (Drug Development)
Part‑time hybrid role based in Boston, MA
About HotSpot Therapeutics, Inc.
At HotSpot Therapeutics, nature is inspiring us to create a wave of new medicines. Through a proprietary technology platform, we are uncovering privileged allosteric sites used by nature to control proteins – called regulatory hotspots – that can be exploited through small molecule drug discovery. Regulatory hotspots are allowing sought‑after targets to be drugged for the first time while delivering molecules with exquisite selectivity and attractive drug‑like properties.
HotSpot is supported by a syndicate of leading healthcare investors based in the US and Europe. You will be joining a seasoned team of drug hunters with an excellent track record in drug discovery.
Summary We are seeking a hands‑on Program Management leader to drive integrated planning and cross‑functional execution for a key pipeline program, with an immediate focus on advancing a lead asset from late discovery through IND and into early clinical development. This role is centered on owning and maintaining the integrated development plan, ensuring clear, high‑quality visibility across timelines, dependencies, critical path, and key assumptions. It focuses on driving cross‑functional alignment and integration across teams to keep the plan current, coordinated, and reflective of evolving program inputs.
Responsibilities
Own, build, and maintain the integrated development plan from late discovery through IND and early clinical development, including timelines, milestones, dependencies, and critical path.
Drive cross‑functional planning and execution across Research, DMPK/Toxicology, CMC, Regulatory, and Clinical, translating inputs into clear, actionable plans.
Coordinate IND‑enabling activities across toxicology, safety pharmacology, CMC readiness, and clinical start‑up, partnering closely with Regulatory on IND/CTA strategy and timelines.
Act as a hands‑on program driver, directly updating plans, tracking progress, and ensuring consistent follow‑through across teams.
Identify and manage program risks, dependencies, and trade‑offs, partnering with functional leads on mitigation strategies and timely escalation.
Lead program team meetings and governance, ensuring clear decision‑making, documentation, and concise communication to leadership.
Support a smooth transition from discovery into early clinical development while championing best‑practice planning tools and processes (e.g., Microsoft Project, Smartsheet).
Qualifications
7–10+ years of program or project management experience in biotech or pharmaceutical settings, including 5+ years supporting drug development programs.
Experience supporting small‑molecule programs across preclinical development and into early clinical stages.
Strong understanding of the drug development lifecycle, including IND‑enabling activities, GLP toxicology, CMC development, regulatory submissions (IND/CTA), and clinical start‑up.
Demonstrated ability to influence without authority and drive alignment in a matrixed environment.
Execution‑focused, detail‑oriented planner who brings clarity to complex dependencies and keeps programs moving forward.
Excellent communication skills, with the ability to synthesize across disciplines.
Boston‑area based with ability to work on‑site two days per week.
Benefits
Competitive salary and bonus plans.
Comprehensive package of benefits plans and fringe benefits.
Generous paid holidays, time off, including company‑wide shutdowns.
Equity ownership opportunities.
Supportive team environment and opportunities for growth and development.
HotSpot is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
At this time, HotSpot is not able to offer Visa sponsorship for this position. Candidates must be authorized to work in the United States without current or future sponsorship.
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About HotSpot Therapeutics, Inc.
At HotSpot Therapeutics, nature is inspiring us to create a wave of new medicines. Through a proprietary technology platform, we are uncovering privileged allosteric sites used by nature to control proteins – called regulatory hotspots – that can be exploited through small molecule drug discovery. Regulatory hotspots are allowing sought‑after targets to be drugged for the first time while delivering molecules with exquisite selectivity and attractive drug‑like properties.
HotSpot is supported by a syndicate of leading healthcare investors based in the US and Europe. You will be joining a seasoned team of drug hunters with an excellent track record in drug discovery.
Summary We are seeking a hands‑on Program Management leader to drive integrated planning and cross‑functional execution for a key pipeline program, with an immediate focus on advancing a lead asset from late discovery through IND and into early clinical development. This role is centered on owning and maintaining the integrated development plan, ensuring clear, high‑quality visibility across timelines, dependencies, critical path, and key assumptions. It focuses on driving cross‑functional alignment and integration across teams to keep the plan current, coordinated, and reflective of evolving program inputs.
Responsibilities
Own, build, and maintain the integrated development plan from late discovery through IND and early clinical development, including timelines, milestones, dependencies, and critical path.
Drive cross‑functional planning and execution across Research, DMPK/Toxicology, CMC, Regulatory, and Clinical, translating inputs into clear, actionable plans.
Coordinate IND‑enabling activities across toxicology, safety pharmacology, CMC readiness, and clinical start‑up, partnering closely with Regulatory on IND/CTA strategy and timelines.
Act as a hands‑on program driver, directly updating plans, tracking progress, and ensuring consistent follow‑through across teams.
Identify and manage program risks, dependencies, and trade‑offs, partnering with functional leads on mitigation strategies and timely escalation.
Lead program team meetings and governance, ensuring clear decision‑making, documentation, and concise communication to leadership.
Support a smooth transition from discovery into early clinical development while championing best‑practice planning tools and processes (e.g., Microsoft Project, Smartsheet).
Qualifications
7–10+ years of program or project management experience in biotech or pharmaceutical settings, including 5+ years supporting drug development programs.
Experience supporting small‑molecule programs across preclinical development and into early clinical stages.
Strong understanding of the drug development lifecycle, including IND‑enabling activities, GLP toxicology, CMC development, regulatory submissions (IND/CTA), and clinical start‑up.
Demonstrated ability to influence without authority and drive alignment in a matrixed environment.
Execution‑focused, detail‑oriented planner who brings clarity to complex dependencies and keeps programs moving forward.
Excellent communication skills, with the ability to synthesize across disciplines.
Boston‑area based with ability to work on‑site two days per week.
Benefits
Competitive salary and bonus plans.
Comprehensive package of benefits plans and fringe benefits.
Generous paid holidays, time off, including company‑wide shutdowns.
Equity ownership opportunities.
Supportive team environment and opportunities for growth and development.
HotSpot is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
At this time, HotSpot is not able to offer Visa sponsorship for this position. Candidates must be authorized to work in the United States without current or future sponsorship.
#J-18808-Ljbffr