Partnology
A Bay Area-based venture-backed biotech company pioneering the development of large molecule antibody therapeutics designed specifically to transform the treatment of autoimmune diseases is seeking a
Head of Development
to join their leadership team. The Head of Development will lead all aspects of development — spanning clinical development, clinical operations, regulatory strategy, CMC oversight, and external partnerships — with the goal of advancing their lead antibody programs from preclinical through Phase 1 trials. This is not a traditional Clinical Development role; they are looking for a versatile development leader who can operate across functions including Regulatory, CMC, Translational and Clinical, move quickly with partners and CROs, and build the roadmap to patients in record time. The Head of Development will define and deliver the clinical development roadmap, with clear near-term milestones that drive programs from preclinical to patients: 6 months:
Define clinical development strategy, align CMC and regulatory planning, oversee tox and IND-enabling activities. 12 months:
Establish regulatory strategy, prepare FDA/EMA/China interactions, and ready first IND/CTA packages. 24 months:
Dose first patients in autoimmune indications across U.S. and ex-U.S. sites. Key Responsibilities Strategic Leadership
Own the end-to-end development function, from CMC through clinical execution. Partner with the CEO and R&D leadership to define development strategy and milestones. Align trial design, regulatory, and manufacturing to accelerate Phase 1 entry. Clinical Development & Operations
Oversee design and execution of early-phase clinical trials. Manage CROs and external partners to ensure efficient, high-quality trial conduct. Define biomarker and translational strategies to de-risk early studies. Regulatory Affairs
Develop and lead global regulatory strategy, including FDA, EMA, and ex-U.S. filings. Oversee IND/CTA preparation and submission. Partner with regulatory consultants to support rapid international trial initiation. CMC & Preclinical Interface
Oversee integration of CMC deliverables with clinical timelines. Ensure tox studies and safety data are aligned to enable rapid IND filing. Leadership & Culture
Build and inspire a small, world-class development team while leveraging fractional FTEs and external partners. Thrive in a lean, scrappy, fast-paced startup environment where speed, adaptability, and accountability are essential. Patient-first urgency: hungry, mission-driven, and committed to getting therapies into the clinic. Qualifications
Advanced degree required: M.D. strongly preferred; Ph.D. with exceptional development leadership will be considered. 12+ years of biotech/pharma experience with a track record of advancing biologics or antibody therapeutics into early clinical trials. Expertise in autoimmune disease drug development required. Bonus: experience with T cell engagers, cell depletion approaches, or global trial initiation (China, EU, AU). Strong understanding of CMC and translational interface with clinical development. Demonstrated ability to run lean programs with CROs/partners and deliver results quickly. Passionate, entrepreneurial, and “hungry” — more than a title-seeker, you are driven by urgency to get therapies to patients. Why Join?
Lead development at one of the most exciting AI-powered biotech startups in autoimmune disease. Work directly with a founder-led executive team and world-class partners. Opportunity to build the entire development function from scratch in a lean, high-impact environment. Competitive compensation, equity participation, and benefits. A mission-first culture where every milestone is celebrated and every role is critical.
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Head of Development
to join their leadership team. The Head of Development will lead all aspects of development — spanning clinical development, clinical operations, regulatory strategy, CMC oversight, and external partnerships — with the goal of advancing their lead antibody programs from preclinical through Phase 1 trials. This is not a traditional Clinical Development role; they are looking for a versatile development leader who can operate across functions including Regulatory, CMC, Translational and Clinical, move quickly with partners and CROs, and build the roadmap to patients in record time. The Head of Development will define and deliver the clinical development roadmap, with clear near-term milestones that drive programs from preclinical to patients: 6 months:
Define clinical development strategy, align CMC and regulatory planning, oversee tox and IND-enabling activities. 12 months:
Establish regulatory strategy, prepare FDA/EMA/China interactions, and ready first IND/CTA packages. 24 months:
Dose first patients in autoimmune indications across U.S. and ex-U.S. sites. Key Responsibilities Strategic Leadership
Own the end-to-end development function, from CMC through clinical execution. Partner with the CEO and R&D leadership to define development strategy and milestones. Align trial design, regulatory, and manufacturing to accelerate Phase 1 entry. Clinical Development & Operations
Oversee design and execution of early-phase clinical trials. Manage CROs and external partners to ensure efficient, high-quality trial conduct. Define biomarker and translational strategies to de-risk early studies. Regulatory Affairs
Develop and lead global regulatory strategy, including FDA, EMA, and ex-U.S. filings. Oversee IND/CTA preparation and submission. Partner with regulatory consultants to support rapid international trial initiation. CMC & Preclinical Interface
Oversee integration of CMC deliverables with clinical timelines. Ensure tox studies and safety data are aligned to enable rapid IND filing. Leadership & Culture
Build and inspire a small, world-class development team while leveraging fractional FTEs and external partners. Thrive in a lean, scrappy, fast-paced startup environment where speed, adaptability, and accountability are essential. Patient-first urgency: hungry, mission-driven, and committed to getting therapies into the clinic. Qualifications
Advanced degree required: M.D. strongly preferred; Ph.D. with exceptional development leadership will be considered. 12+ years of biotech/pharma experience with a track record of advancing biologics or antibody therapeutics into early clinical trials. Expertise in autoimmune disease drug development required. Bonus: experience with T cell engagers, cell depletion approaches, or global trial initiation (China, EU, AU). Strong understanding of CMC and translational interface with clinical development. Demonstrated ability to run lean programs with CROs/partners and deliver results quickly. Passionate, entrepreneurial, and “hungry” — more than a title-seeker, you are driven by urgency to get therapies to patients. Why Join?
Lead development at one of the most exciting AI-powered biotech startups in autoimmune disease. Work directly with a founder-led executive team and world-class partners. Opportunity to build the entire development function from scratch in a lean, high-impact environment. Competitive compensation, equity participation, and benefits. A mission-first culture where every milestone is celebrated and every role is critical.
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