Sr. Director

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, ADC STP-100, designed to avoid on-target/off-tumor toxicity, is expected to enter clinical studies in early 2027 with a significant number of indications and product concepts which can evolve into additional future programs. Stipple Bio is well capitalized and has announced a $100M Series A financing which supports the company into 2029. Summary: The Sr. Director / Vice President, Clinical Operations will build and lead Stipple's clinical operations function as STP-100 enters the clinic in early 2027. Reporting to the Chief Medical Officer, they will be the company's first clinical operations hire and will own execution of the STP-100 first-in-human master protocol, which covers dose escalation, backfill and dose expansion cohorts in biomarker-selected solid tumors, along with combination arms with other targeted agents. They will select and manage the CROs, sites and vendors that run the study in the US and international site locations, keep enrollment, data quality and budget on plan, and work with CMC to keep clinical drug supply ahead of demand. Over 2027 and 2028 they will hire a clinical operations team and put in place the processes and systems Stipple needs to add indications and combination cohorts. This is a hands-on role: early on, the Sr. Director / VP will do much of the operational work directly while building the team around it. Job Duties:
• Build and lead the clinical operations function, hiring clinical trial managers, CRAs and clinical trial associates in line with 2027/28 workforce plans, and decide what to staff in-house versus outsource.
• Own operational delivery of the STP-100 master protocol through dose escalation, backfill and dose expansion cohorts, and combination arms.
• Lead study start-up in the US and internationally, including site feasibility and selection, site contracts and budgets, IRB/HREC submissions, site activation and first-patient-in readiness.
• Select, contract and oversee CROs and specialty vendors (central and specialty labs, biomarker testing, imaging, EDC, IRT), set performance metrics, and hold vendors accountable for quality, timelines and cost.
• Drive enrollment, including biomarker-selected cohorts, through strong relationships with investigators and site staff, and adjust recruitment plans when enrollment falls behind.
• Partner with CMC on clinical supply planning, including drug product forecasting, labeling, distribution and site resupply, and coordinate supply of combination agents provided by partners.
• Build and manage the clinical operations budget and forecast with Finance, including accruals, CRO and site payments, and tracking of eligible expenses for the Australian R&D tax incentive.
• Make sure studies run in compliance with ICH-GCP, FDA and Australian (TGA/CTN) requirements, and establish the SOPs, trial master file practices and oversight plans needed for inspection readiness.
• Work with the CMO, drug safety, clinical regulatory, biostatistics and data management to deliver clean, timely data for dose escalation decisions, safety review meetings and data readouts.
• Plan protocol amendments that add indications or combination cohorts, including feasibility, timeline and cost scenarios for the leadership team and Board.
• Manage the operational side of clinical collaborations with partners, including combination study logistics and data sharing.

Qualifications:
• 12+ years of clinical operations experience in biotech or pharma, including at least 5 years leading clinical operations staff and outsourced studies.
• Hands-on experience running oncology trials, ideally first-in-human dose escalation and expansion studies. Experience with ADCs or other targeted therapies is strongly preferred.
• Track record of starting up and running studies in the US and outside the US. Experience with Australian and other international sites and the CTN scheme is a plus.
• Experience with biomarker-selected enrollment, combination studies, and master or multi-cohort protocols.
• Demonstrated success selecting and managing CROs and vendors, including contracting, budget management and performance oversight.
• Deep working knowledge of ICH-GCP and FDA regulations, and experience preparing for audits and inspections.
• Experience building a clinical operations team at a small company is strongly preferred, along with a willingness to do the work directly while that team is being built.
• While real world accomplishments will be the primary source of calibrating candidacies, a degree in the life sciences or nursing is expected and an advanced degree is a plus.