• Oversees the execution and regulatory compliance of clinical studies • Conducts and oversees all aspects of clinical studies, ensuring strict compliance with regulatory standards (ISO, GCP, FDA) and Philips procedures • Optimizes study efficiency and data quality through process improvements • Collaborates with Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D, and other internal teams • Monitors study progress against milestones, timelines, and budgets; proactively identifies risks and resolves issues

Role Description We are looking for a Clinical Expert to support Bioptimus’ clinical and scientific strategy for digital twin and data generation programs. In this role, you will work closely with the science, data, and partnerships teams to support clinical prioritization, scientific interpretation, academic collaborations, and pharma engagement across our research programs. You will contribute clinical and translational expertise to help identify the most important clinical questions and modalities to focus on, support the interpretation of model outputs, and advise on partnerships and research programs aligned with Bioptimus’ data and scientific goals. This is a part-time engagement with the possibility of becoming full-time. What You'll Be Doing - Clinical Strategy: - Support the identification of the most important clinical questions and modalities to prioritize across training and validation cohorts. - Provide clinical input on tissue, drug class, disease, and modality prioritization. - Support the selection of clinical metadata, endpoints, and patient-level annotations required to maximize downstream model utility. - Identify and prioritize clinically relevant tasks including response prediction, toxicity prediction, biomarker discovery, indication expansion, and trial enrichment. - Scientific Interpretation: - Provide clinical and biological review of model outputs and scientific results. - Work closely with the science team to support results review and contribute to external-facing scientific narratives. - Translate model behavior into clinically credible language for pharmaceutical, key opinion leader, and regulatory audiences. - Data & Academic Partnerships: - Support connections with academic investigators running relevant clinical studies, including early-phase studies, novel-agent programs, immuno-oncology programs, and multimodal cohorts. - Advise on academic partnership structures that align research collaborations with Bioptimus’ data needs, including retrospective and prospective studies. - Pharma Engagement: - Support discussions with pharmaceutical R&D teams where relevant. - Advise on the positioning of model claims for translational medicine and clinical development audiences. Qualifications - MD/PhD with active or recent Principal Investigator experience designing and analyzing clinical studies, particularly studies involving translational endpoints, biomarker sub-studies, and multimodal cohorts. - Deep expertise in onco-immunology, including IO mechanisms, response and resistance biology, tumor microenvironment biology, IO combinations, and understanding of pharmaceutical pipelines and unmet clinical needs. - Working understanding of and genuine interest in machine learning and foundation model approaches applied to pathology, transcriptomics, and multimodal data integration. - Ability to work closely with scientific, clinical, and external stakeholder groups. - Strong communication skills with the ability to contribute to scientific discussions and external-facing narratives. - Comfortable operating in a startup environment with ambiguity and evolving priorities. How to Stand Out - Pharma R&D experience through an industry role or substantive pharmaceutical collaboration history. - Existing academic or hospital network in onco-immunology. - Experience designing and analyzing studies involving translational endpoints, biomarker sub-studies, or multimodal cohorts. - Familiarity with ML or foundation model approaches in pathology, transcriptomics, or multimodal biology. The Candidate Journey - Screening: Once you have applied, the hiring team will review your application to determine if your work experience and skills align with the necessary proficiencies of this position. - Hiring Manager (30 min): A discussion with the Hiring Manager focused on your clinical and translational research background, scientific expertise, and motivation for collaborating with Bioptimus. - Strategic Case Study Discussion (60 min): A collaborative discussion with members of the scientific and technical teams focused on clinical strategy, translational medicine, multimodal biology, and the application of foundation models in oncology and immunology. - Offer: Following the completion of the interviews, our hiring team will make a final decision and will be in touch to share the outcome of your interviews. If the team would like to move forward, the recruiter will discuss the details of our proposed offer with you. - Onboarding: We are happy to have you joining the team. Once you have accepted and signed your offer, we will be in touch to begin the process of onboarding you to Bioptimus. Why This is a Unique Opportunity - Be part of a trailblazing team working at the intersection of AI, biotech, and biomedical research. - Take on a high-impact leadership role, shaping the future of biomedical AI through strategic data partnerships. - Work in a collaborative, innovation-driven environment with top researchers and industry experts.

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) • Identify and develop training needs for CRAs and third-party vendors specific to the study • Generate potential site list from key stakeholders and drive site feasibility process • Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment • Develop and finalize the country recruitment/retention strategy • Develop timely and effective communication and good working relationships with investigators and study team • Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs • Address all CRA and site questions and maintains FAQ log • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies for assuring study timelines are met • Generate and utilize metric reporting to ensure that the study is conducted per plan • Responsible for eTMF implementation and management • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits • Work closely with PM for project-specific resourcing issues • Escalate pertinent CRA performance and site compliance issues when necessary • Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines • Manage processes for investigational product (IP) including drug accountability and reconciliation • Supports business development and marketing activities as appropriate

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work • Ensure that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) • Identify and develop training needs for CRAs and third-party vendors specific to the study • Generate potential site list...