VP, Clinical Development

Hlx Life Sciences; Massachusetts; On-site; USD 320,000 - 520,000; Full time

Job summary

Hlx Life Sciences in the Greater Boston area is seeking a Vice President of Clinical Development to lead the company’s clinical strategy and advance its rare kidney disease programs. This is a senior appointment reporting to the CMO with cross-functional responsibility across R&D functions and external partners.

You will drive development plans for multiple programs, oversee Phase II/III programs, interact with global regulators, and mentor clinical teams as the portfolio grows.

Qualifications

• MD or equivalent medical degree with significant industry clinical development experience.
• Strong expertise in nephrology, renal medicine, or rare kidney disease.
• Track record leading clinical programs through meaningful development milestones.
• Experience across Phase II and Phase III with late-stage development preferred.
• Experience interacting with regulatory authorities including the FDA.
• Exposure to regulatory submissions and NDA/BLA experience is advantageous.
• Strong understanding of trial design, data interpretation and development strategy.
• Ability to operate in cross-functional, matrixed R&D environments.
• Capability to balance portfolio strategy with hands-on clinical decisions.
• Excellent communication with executive leadership and external partners.

Responsibilities

• Lead clinical development strategy across multiple programs from planning to regulatory milestones.
• Provide senior medical leadership for kidney and rare disease programs.
• Develop and oversee plans including design, endpoints and program progression.
• Lead programs through mid- and late-stage development and regulatory interactions.
• Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics and Medical Affairs.
• Represent Clinical Development in interactions with global regulators and external partners.
• Evaluate emerging data and translate findings into strategic recommendations.
• Contribute clinical input to pipeline expansion and business development.
• Build and mentor clinical development teams; partner with senior leadership.
• Serve as a strategic partner to the CDO and executive leadership.

Skills

Clinical development leadership

Regulatory interactions (FDA)

Strategic portfolio planning

Cross-functional collaboration

Communication skills

Mentorship and team development

Education

MD or equivalent medical degree

Job description

We are partnering with an established, commercial-stage biotechnology company to appoint a Vice President of Clinical Development to join its R&D leadership team.

The organization has an established commercial presence alongside a growing development pipeline focused on areas of significant unmet medical need, with a particular emphasis on rare and specialist kidney diseases.

This is a senior and highly visible appointment that will play an important role in shaping the company's clinical development strategy and advancing its pipeline. The successful individual will work closely with the CMO, executive leadership team and cross-functional R&D functions, providing both strategic and hands-on leadership across clinical programs.

The position represents an opportunity to join an organization with an established infrastructure and commercial footprint while helping shape the next phase of its R&D growth.

The VP, Clinical Development will provide strategic and medical leadership across the company's clinical development portfolio, with responsibilities including:

• Lead clinical development strategy across multiple programs, from development planning through execution and regulatory milestones.
• Provide senior medical and scientific leadership for programs focused on kidney and rare disease.
• Develop and oversee clinical development plans, including study design, protocol development, endpoint strategy and overall program progression.
• Lead and support programs through mid- and late-stage clinical development, including preparation for key regulatory interactions and submissions.
• Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics, Medical Affairs, Translational Medicine and other R&D functions.
• Represent Clinical Development in interactions with global regulatory authorities, external experts, investigators and development partners.
• Evaluate emerging clinical data and translate findings into clear strategic recommendations for individual programs and the broader portfolio.
• Provide clinical and scientific input into pipeline expansion, business development and external opportunities where appropriate.
• Build strong relationships with leading investigators, KOLs and the wider nephrology community.
• Provide leadership, mentorship and development to clinical development colleagues as the organization and portfolio continue to grow.
• Act as a senior strategic partner to the CDO and broader executive leadership team.

We are looking to speak with senior physician leaders who combine strong scientific and medical credibility with extensive experience developing therapeutics within biotech or pharmaceutical organizations.

The ideal candidate will bring:

• MD or equivalent medical degree with significant industry clinical development experience.
• Strong expertise within nephrology, renal medicine and/or rare kidney disease.
• A track record of leading clinical programs through meaningful development milestones.
• Experience across Phase II and Phase III development, with late-stage development experience strongly preferred.
• Experience interacting directly with regulatory authorities including the FDA.
• Exposure to regulatory submissions and ideally experience contributing to an NDA/BLA or successful approval.
• Strong understanding of clinical trial design, benefit/risk assessment, data interpretation and development strategy.
• Experience operating effectively within cross-functional and matrixed R&D environments.
• The ability to move between high-level portfolio strategy and hands-on clinical decision-making.
• Strong communication skills and the credibility to engage with executive leadership, Boards, external partners, investigators and KOLs.
• Previous experience building, managing and developing clinical teams would be highly advantageous.

This is an opportunity to take on a significant clinical leadership position within an established biotechnology organization at an important stage of its development.

The successful individual will have the ability to influence development strategy, advance important programs for patients with kidney disease and help shape the future clinical portfolio, while working alongside an experienced senior leadership team.

The position will be based in the Greater Boston area, with relocation support available for the right individual.

This search is being conducted on a confidential basis.