Chief Development Officer

Hlx Life Sciences; United States; On-site; USD 450,000 - 900,000; Full time

Job summary

HLX Life Sciences is seeking a Chief Development Officer to lead Clinical Development, Clinical Operations and Regulatory Affairs for a renal and rare disease biotech in the clinical stage.

Reporting to the CEO and Board, the CDO will shape the development strategy, advance the pipeline through milestones and build high-performing teams across external partners and internal functions.

Qualifications

• Significant leadership experience in biotech/pharmaceutical clinical development.
• Experience overseeing Clinical Development, Clinical Operations and Regulatory functions.
• Strong knowledge of rare disease development and related complexities.
• Experience advancing assets through clinical and regulatory milestones.
• Ability to operate strategically at executive level while staying close to execution.
• Strong cross-functional leadership and communication skills.
• Renal/nephrology development experience desired.
• Previous CDO/Head of Development/SVP or equivalent leadership preferred.

Responsibilities

• Provide strategic leadership across Clinical Development, Clinical Operations and Regulatory.
• Own and execute overall clinical and regulatory development strategy.
• Oversee design and delivery of clinical programs with study/execution excellence.
• Lead interactions with regulators including the FDA.
• Partner with CEO, Board on pipeline and corporate strategy.
• Build and lead development teams and external partners.
• Establish relationships with investigators and KOLs.
• Support future pipeline expansion and broader development opportunities.

Skills

Leadership in clinical development

Regulatory affairs leadership

Cross-functional leadership

Strategic planning

Stakeholder engagement

Education

MD or PhD welcomed

Job description

Chief Development Officer – Renal / Rare Disease Biotech

We are partnering with an innovative, clinical-stage biotech company focused within renal and rare disease to appoint a Chief Development Officer (CDO).

This is a key executive leadership position with broad responsibility across Clinical Development, Clinical Operations and Regulatory Affairs. The CDO will work closely with the CEO, Board and wider leadership team to shape and execute the company’s development strategy and advance its pipeline through key clinical and regulatory milestones.

Key Responsibilities:

• Provide strategic leadership across Clinical Development, Clinical Operations and Regulatory Affairs
• Own and execute the overall clinical and regulatory development strategy
• Oversee the design and delivery of clinical programs, ensuring operational excellence across studies
• Lead interactions and strategy with regulatory authorities, including the FDA
• Partner closely with the CEO, Board and executive leadership team on pipeline and corporate strategy
• Build, develop and lead high-performing development teams and external partners
• Establish strong relationships with investigators, KOLs and other key external stakeholders
• Support future pipeline expansion and broader development opportunities

Experience Required:

• Significant leadership experience within biotech/pharmaceutical clinical development
• Demonstrated experience overseeing multiple functions across Clinical Development, Clinical Operations and Regulatory
• Strong understanding of rare disease clinical development and the complexities associated with rare disease studies
• Experience advancing clinical-stage assets through meaningful development and regulatory milestones
• Ability to operate both strategically at an executive level and remain close to program execution
• Strong cross-functional leadership and communication skills
• Renal/nephrology development experience is highly desirable
• Previous CDO, Head of Development, SVP or equivalent leadership experience preferred
• MD and/or PhD is welcomed but not essential

This is an opportunity to take a broad leadership role within a growing renal biotech and have significant influence over both the development organisation and future direction of the company.

For a confidential discussion, please contact: