Director, Program and Portfolio Management

Stipple Bio; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Stipple Bio, Inc. is seeking a Director of Program and Portfolio Management to lead the STP‑100 program from IND‑enabling work to first‑in‑human studies.

You will own the integrated plan, timeline and budget, coordinating with research, nonclinical, CMC, regulatory, clinical operations and finance, and report risks and trade‑offs to the leadership team. This hands‑on role will establish planning processes, governance and tools that scale as the company grows, including scope for follow‑on

Qualifications

• 8+ years of drug development experience in biotech or pharma with cross‑functional leadership.
• Experience taking a program through IND submission into first‑in‑human studies.
• Knowledge of nonclinical, CMC, regulatory and clinical operations and their dependencies.

Responsibilities

• Lead cross‑functional STP‑100 program, set cadence, agendas and decision logs.

Skills

Cross-functional leadership

IND submission

Budget management

Program planning

Vendor management

Strategic decision making

Communication to leadership

Education

Advanced degree (PhD, PharmD, MS or MBA) or PMP

Tools

Smartsheet

MS Project

OnePager

Job description

Stipple Bio, Inc. is a private biotechnology company harnessing epitope-level precision to create targeted cancer therapies. We have pioneered a Pointillist ‘epitomics’ discovery platform to unlock unique tumor-specific epitopes and develop a pipeline of next-generation precision oncology therapeutics with a high therapeutic index. Our lead candidate, STP-100, designed to avoid on-target/off-tumor toxicity, is expected to enter clinical studies in early 2027 , and is followed by several platform derived product concepts which could evolve into additional future pipeline programs. Stipple Bio is well capitalized and has announced a $100M Series A financing which supports the company into 2029.

Summary:

Reporting to the Chief Business Officer, the Director, Program and Portfolio Management will lead cross-functional preclinical and clinical programs including STP-100 as it moves from IND-enabling work into a first-in-human study in early 2027. Working day to day with research, nonclinical, CMC, regulatory, clinical operations and finance, they will own the integrated cross-functional program plan, timeline and budget, keep the team on track to IND submission, first patient dosed and throughout the programs development lifecycle, and give the leadership team a clear, current view of program risks, decisions and trade-offs. As Stipple's first dedicated program management hire, they will also set up the planning processes, tools and governance the company will rely on as STP-100 advances and new programs advance from the platform. This is a hands‑on role: in a company of our size, the Director will often draft the plans, run the meetings and chase the action items themselves.

Job Duties:

• Responsible for program and portfolio management for Stipple’s cross‑functional STP‑100 program team: set the meeting cadence, agendas and decision log, and hold functions accountable to agreed deliverables and dates.
• Build and maintain the integrated program plan from IND‑enabling studies through IND submission, first patient dosed and early clinical readouts, combination studies, and including the critical path, cross‑functional dependencies and scenario plans.
• Coordinate IND preparation and amendments across Regulatory, Nonclinical, CMC and Clinical, tracking module authoring, review cycles and pre‑IND meeting preparation so the submission stays on schedule.
• Work with CMC and CDMO partners to track antibody, linker‑payload, conjugation and fill/finish timelines, and tie drug supply plans to clinical start‑up and enrollment projections.
• Partner with Clinical Operations on study start‑up, including CRO selection, site activation and first‑patient‑in readiness.
• Oversee program‑level timelines and deliverables for CROs, CDMOs and other vendors, and flag scope changes and slippage early.
• Build and maintain the program budget with Finance, reconcile actuals to forecast, and model the cost and timeline impact of alternative plans.
• Identify, assess and track program risks and mitigation plans, and bring decisions that need leadership input forward with clear options and a recommendation.
• Prepare program updates for the executive team and Board and, as needed, for investors and potential partners.
• Put in place program management processes and tools (planning software, dashboards, templates, stage‑gate criteria) that fit a small company and can scale to a multi‑program pipeline.
• Support development planning for follow‑on programs from the discovery platform, including target product profiles and early development plans, in collaboration with the CSO and CBO.

Qualifications:

• 8+ years of drug development experience in biotech or pharma, including at least 4 years managing or leading cross‑functional programs or project teams.
• High analytical and strategic decision‑making capacity under conditions of scientific uncertainty
• Direct experience taking a program through IND (or CTA) submission and into first‑in‑human studies with multi‑country clinical sites. Experience with biologics or ADCs is strongly preferred, and oncology experience is preferred.
• Working knowledge of nonclinical, CMC, regulatory and clinical operations, and of how their timelines and dependencies interact.
• Track record of managing outsourced work through CROs and CDMOs, and of building and tracking program budgets with Finance.
• Proficiency with planning tools such as Smartsheet, MS Project or OnePager.
• Comfortable in a small company where the role covers both strategy and execution, and able to lead through influence without direct authority over functional leads.
• Clear, concise written and verbal communicator who can present to senior management.
• While real world accomplishments will be the primary source of calibrating candidacies, a degree in the life sciences is expected and an advanced degree (PhD, PharmD, MS or MBA) or PMP certification is a plus.