About Stipple Bio:
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.