Director Clinical Development

Director Clinical Development at Hlx Life Sciences Director Clinical Development at Hlx Life Sciences in Winthrop, Massachusetts Posted in 1 day ago.

Type:

full-time

Job Description:

HLX Life Sciences is partnering with an innovative, renal biotech based in Boston that is advancing a differentiated pipeline of therapeutics targeting serious kidney diseases with high unmet medical need. Leveraging cutting-edge science and a patient-centric development strategy, the company is building a robust clinical portfolio focused on transforming outcomes for patients across rare and chronic renal indications. Backed by a highly experienced leadership team and top-tier investors, the organisation is entering an exciting phase of clinical expansion and is seeking a Director of Clinical Development to play a central role in shaping and executing its development strategy. The Opportunity The Director, Clinical Development will provide medical and scientific leadership across ongoing and planned clinical programmes within the renal portfolio. Working cross-functionally with Clinical Operations, Translational Medicine, Regulatory Affairs, Biometrics, Medical Affairs, and external investigators, this individual will contribute to the design, execution, interpretation, and communication of clinical studies from phase 2 onwards. This is a highly visible role offering the opportunity to influence programme strategy, engage directly with key opinion leaders, and help build a best-in-class clinical development organisation. Key Responsibilities Contribute to the overall clinical development strategy for renal assets across multiple stages of development. Lead the medical design and execution of Phase II-III clinical trials, including protocol development, endpoint selection, eligibility criteria, and safety monitoring plans. Serve as a medical lead for assigned studies and support cross-functional study teams. Interpret clinical data and contribute to integrated analyses, study reports, publications, abstracts, and regulatory submissions. Participate in interactions with global regulatory authorities, ethics committees, and external stakeholders. Build and maintain strong relationships with key opinion leaders, investigators, academic institutions, and patient advocacy groups within nephrology. Provide clinical and scientific input into translational and biomarker strategies. Support safety review activities, data monitoring committees, and benefit-risk assessments. Collaborate closely with Clinical Operations to ensure high-quality study execution and delivery against timelines. Represent Clinical Development at internal governance meetings and external scientific congresses. Mentor and support junior clinical team members as the organisation continues to scale. Required Qualifications MD, DO, or equivalent medical degree required. Significant industry experience within Clinical Development in biotech or pharmaceutical environments. Prior experience supporting or leading clinical studies in nephrology, renal disease, or adjacent therapeutic areas. Strong understanding of clinical trial methodology, GCP, regulatory requirements, and drug development processes. Experience contributing to NDAs / regulatory submissions, and health authority interactions. Demonstrated ability to interpret and communicate complex clinical and scientific data. Strong cross-functional collaboration and stakeholder management skills. Excellent written and verbal communication capabilities. Ability to thrive in a fast-paced, collaborative biotech environment. Preferred Qualifications Board certification in Nephrology or Internal Medicine preferred. Experience in rare renal diseases, CKD, glomerular diseases, or immunology-related renal disorders. Exposure to early-stage biotech or high-growth environments. Experience working with global clinical programmes and international trial sites. Why Join? Opportunity to join a high-growth renal biotech at a pivotal stage of development. Highly collaborative and scientifically driven culture. Direct exposure to executive leadership and strategic decision-making. Competitive compensation package including salary, bonus, equity, and comprehensive benefits. Hybrid working environment based in Boston. Chance to make a meaningful impact for patients living with serious kidney diseases. To learn more, please apply directly or email George.

Pyett@hlxlifesciences.com