Head of Clinical Development

elemed; New York (NY); Hybrid; USD 300,000 - 550,000; Full time

Benefits offered by this job

Relocation package

Job summary

Elemed seeks a Head of Clinical Development to own oncology assets end to end in a hybrid New York environment. You will drive strategy, regulatory interactions, trial design, and go/no-go decisions while guiding a small, autonomous team and a fleet of AI agents for document drafting and data triage.

You will translate AI-enabled insights into biomarker-driven trial designs, maintain oversight of regulatory submissions with FDA/EMA, and shape the scientific narrative across asset development in

Qualifications

• MD or MD/PhD with substantial oncology drug development experience.
• Demonstrated end-to-end ownership of a clinical asset and regulatory strategy.
• Openness to working in an AI-first, non-hierarchical environment.

Responsibilities

• Own the development strategy for one or more oncology assets from IND through registrational planning.
• Lead regulatory strategy and sponsor interactions with health authorities.
• Oversee medical oversight across active studies and monitor safety signals in real time.
• Coordinate across biostatistics, data management, and clinical operations to align priorities.

Skills

Strategic leadership

Regulatory interactions

Cross-functional collaboration

AI-enabled development

Education

MD or MD/PhD in oncology

Job description

Hybrid- 3 days a week on site in New York

Relocation package offered

You have spent a decade or more leading oncology programmes inside large pharma or building out clinical teams at a biotech. The question is whether you want to keep doing it the same way, or do something genuinely different with what you know.

The Company

This company is not a traditional biotech that has bolted an AI tool onto its existing workflow. It was built from first principles around an AI and technology core, and that distinction shapes everything about how it operates.

Its model reads across DNA, RNA, pathology, and clinical text on a dataset of multimodal oncology records. Every major portfolio decision in Q1 2026 was informed by the platform. That is not a pilot. That is how the company runs.

The teams are small by design. Functions across clinical, regulatory, finance, legal, and engineering are each built as groups of three to six subject matter experts, each directing a fleet of AI agents to do work that would traditionally require dozens of people. The people who thrive here are deep experts who know exactly what needs to happen and can specify, oversee, and judge at pace.

The Opportunity

A growing AI-driven company with clinical-stage programmes and the capital to match its ambition needs someone to own those assets end to end.

As Head of Clinical Development, you will report directly to the CEO and serve as the single accountable leader for your programme(s). That means full ownership: strategy, regulatory interactions, trial design, go or no-go calls, and the scientific narrative of the asset. You will lead a small, autonomous team and direct a fleet of AI agents handling document drafting, literature surveillance, safety-signal monitoring, and data triage, freeing your time for the medical and strategic judgement that actually moves a programme forward.

In practice, this is a CMO-level remit in all but name. You will carry assets from IND-enabling work through to registrational strategy, translating the outputs of the oncology model into biomarker-driven trial designs built around the right patients from the start.

If you want to build, own, and ship at a pace that traditional drug development rarely allows, this is where that becomes possible.

What You'll Be Doing

• Own the full development strategy for one or more oncology assets, from IND-enabling activities through to registrational planning, and serve as the single voice into portfolio governance and investment decisions.
• Design precision, biomarker-driven protocols by translating foundation model predictions and real-world evidence into trial designs that identify the right patient populations sooner.
• Define regulatory strategy and act as senior sponsor in FDA and EMA interactions, owning the clinical and scientific content of briefing books, IND amendments, and key submissions.
• Lead medical oversight across active studies, using platform dashboards to track enrolment, safety signals, and biomarker data in real time from site activation through to closeout.
• Direct your cross-functional team of clinical and scientific staff and orchestrate a fleet of AI agents to execute document-heavy tasks that would traditionally consume a development leader's calendar.
• Provide matrix leadership across biostatistics, medical monitoring, data management, and clinical operations, aligning functional experts around the priorities of the asset.
• Own and develop investigator and KOL relationships for your programme, and maintain a sharp view of the competitive and scientific landscape to inform development decisions.
• Make the high-judgement scientific and commercial calls, including go or no-go decisions, that determine where the programme goes at each milestone.

What We're Looking For

• MD or MD/PhD with substantial oncology drug development experience, ideally including breast cancer or NSCLC programmes.
• Ten or more years in drug development, including senior leadership as a VP or SVP of Clinical Development at a pharmaceutical company, or as CMO at a biotech.
• Demonstrated end-to-end ownership of a clinical asset, covering regulatory strategy, protocol design, health authority interactions, and pipeline-level go or no-go decisions.
• Genuine openness to working in an AI-first, non-hierarchical environment