About this role
SJP Biotec GmbH is a clinical-stage precision oncology company pioneering a first-in-class Selective Translation Regulatory Inhibitor (STRI) platform powered to overcome treatment resistance in refractory cancers. Founded in 2024, SJP targets RAS-driven, hormone-receptor-positive, and immune-refractory tumors with a novel pipeline of small molecules developed in our lab and ready to proceed with regulatory-grade trials. Backed by a Scientific Advisory Board that includes world-leading authorities in RAS and breast cancer biology, and immuno-oncology, SJP has established clinical partnerships with leading medical centers world-wide including UCSF, NCI, MD Anderson, Baylor College of Medicine, MSKCC, and McGill, to name a few.
The Opportunity This is a stimulating and unique opportunity to join a scientifically exceptional, capital-efficient biotech company doing groundbreaking work at a pivotal inflection point. The CMO/SVP of Clinical Development will serve as the company's most senior clinical leader, responsible for designing and executing a multi-indication clinical development strategy across one of the most compelling areas in the current oncology drug development field - RAS/eIF4A/translation-pathway inhibition.
Key Responsibilities • Translate and deliver key directives from the board and senior management, and serve as the clinical face of the company. • Lead and manage all clinical development activities across the SJP portfolio • Design Phase 2 and 3 clinical protocols and oversee CTA/IND submissions to BfArM, FDA, and EMA • Develop and implement biomarker-driven patient selection strategies • Build and manage relationships with leading academic and clinical sites across Germany, the EU, and the US • Oversee Investigator Initiated Trials and partnerships, providing scientific leadership and interactions as required • Lead regulatory strategy, developing approaches for Fast Track Designation, Breakthrough Therapy Designation, and accelerated approval pathways as applicable • Support pharmaceutical partnering activities - prepare clinical data packages and respond to due diligence for potential licensing and out-licensing transactions • Build out of the clinical development and operations function, including recruitment of CRAs, medical monitors, and data management staff • Present clinical data at major oncology congresses and to key opinion leaders • Interact with potential investors and financial institutions to raise capital when needed.
Candidate Profile Essential Qualifications • MD, with specialization in medical oncology and hematology • 10+ years of experience in oncology clinical development within pharma, biotech, or CRO settings with hands-on clinical trial leadership • Demonstrated track record of successful IND/CTA submissions • Leadership of interactions with FDA and/or EMA • Experience with biomarker-driven trial design and companion diagnostic development • Expertise in breast cancer, NSCLC, and KRAS-mutant tumor biology • Strong understanding of the competitive treatment landscape in clinical oncology • Proven ability to manage investigator-initiated trials and academic site partnerships • Strong scientific publication and/or congress presentation record in clinical oncology • Excellent presentation skills • Emphasizing teamwork and leading a team of experts in their fields
Highly Desired (But not required) • Experience with RAS/KRAS biology, MAPK pathway inhibitors, or translation-pathway therapeutics • PhD in an associated area of cancer biology • Experience with basket trial design and multi-cohort oncology studies • Background in immuno-oncology combinations, particularly in checkpoint inhibitor resistance settings • Prior involvement in pharma partnering or licensing due diligence from the biotech side • Working knowledge of German regulatory frameworks alongside international GCP/ICH guidelines • Established professional network at leading cancer centres