VP/Head of Clinical Development

Engine Biosciences is seeking a highly experienced and dynamic Head of Clinical Development to lead the transition of our novel oncology therapeutics from preclinical development into clinical trials. This key leadership role will be responsible for designing and executing clinical strategies, overseeing clinical operations, and ensuring the successful advancement of our programs. The ideal candidate will bring deep expertise in oncology drug development, a strong strategic mindset, and the ability to collaborate effectively across multidisciplinary teams and external partners.

• Lead the clinical development strategy and execution for Engine Biosciences’ oncology pipeline, ensuring alignment with regulatory requirements and corporate objectives.
• Oversee the design, implementation, and management of early-phase clinical trials, including protocol development, site selection, and patient recruitment strategies.
• Work cross-functionally with preclinical, regulatory, and translational science teams to optimize clinical development plans and biomarker-driven patient selection approaches.
• Serve as the primary clinical expert, interfacing with regulatory agencies (FDA, EMA, etc), key opinion leaders (KOLs), and strategic partners.
• Establish and maintain strong relationships with clinical investigators, CROs, and external collaborators to ensure high-quality clinical trial execution.
• Drive data analysis and interpretation, contributing to regulatory submissions, investor presentations, and scientific publications.
• Provide leadership and mentorship to the clinical development team, fostering a high-performance culture within a fast-paced biotech environment.
• Participate in development of clinical budgets, working with clinical operations and finance teams to budget and ensure cost-effective execution of clinical trials while maintaining high-quality and regulatory compliance.
• Contribute to strategic decision-making on portfolio prioritization, risk assessment, and long-term development planning.
• Support financing and business development efforts by effectively communicating clinical strategy, progress, and impact to investors and potential partners.

The above listed responsibilities are essential duties associated with this position; however, they are not an exhaustive list. Changes to individual responsibilities may occur due to business needs.

• MD or MD/PhD with board certification in oncology, or a related field.
• 10+ years of experience in clinical development within the biotech or pharmaceutical industry, with a strong focus on oncology.
• Proven track record of leading early-phase clinical trials and successfully advancing therapeutics from IND-enabling studies to clinical proof-of-concept.
• Expertise in precision medicine approaches, biomarker-driven clinical development, clinical trial design, and regulatory interactions.
• Strong leadership, communication, and strategic-thinking skills, with the ability to work collaboratively in a multidisciplinary environment.
• Experience managing relationships with external stakeholders, including regulatory agencies, investigators, and corporate partners.
• Hands-on experience in biotech in early-phase trial settings, with ability to thrive in a fast-paced, entrepreneurial setting and drive clinical programs efficiently.
• Strong business acumen, with experience in supporting investor and business development communications.

To apply, please e-mail your CV to Careers@enginebio.com