About the Role
Lead clinical science and scientific affairs for a Class III program, designing and executing the clinical evidence strategy for a successful PMA. Build a strong scientific foundation through KOL engagement, publications, and medical education in a startup environment.
Responsibilities
- Own the clinical evidence strategy in support of the Class III PMA pathway, including IDE strategy, pivotal trial design, endpoints, and statistical considerations.
- Lead the development of clinical protocols, investigator brochures, clinical investigation plans, and related study documents.
- Drive clinical data interpretation, evidence synthesis, and preparation of clinical sections for regulatory submissions.
- Partner closely with Regulatory, Quality, and R&D to ensure clinical evidence aligns with design controls, risk management, and overall product strategy.
- Lead scientific affairs strategy, including KOL identification, advisory board development, and long-term scientific partnerships.
- Drive publication and congress strategy (abstracts, manuscripts, presentations) to build clinical awareness and scientific credibility.
- Represent the company at key scientific and medical meetings; support medical education and training initiatives.
- Serve as a scientific spokesperson with clinicians, investigators, and external stakeholders.
- Provide clinical and scientific input to Board updates, investor materials, and due diligence processes.
- Contribute to reimbursement and health economics strategy through clinical evidence planning.
Requirements
- Advanced degree (MD, PhD, PharmD, or equivalent) in a relevant scientific or clinical field.
- Demonstrated success leading clinical strategy and evidence generation for at least one Class III PMA (or equivalent high-risk pathway).
- Strong expertise in clinical trial design, endpoints, biostatistics interpretation, and GCP/FDA clinical regulations.
- Proven ability to engage and manage KOLs, build advisory boards, and drive high-impact publications and scientific communications.
- Experience operating in a startup or high-growth environment, with comfort being both strategic and hands-on.
- Excellent written and verbal communication skills; ability to translate complex clinical science for diverse audiences (regulators, investors, clinicians, Board).
- Direct experience with IDE submissions, pivotal trial execution, and PMA clinical modules.
- Background in complex devices (e.g., implants, interventional systems, or software-enabled technologies).
- Prior leadership of a clinical or scientific affairs function in a Series A–C company.
- Experience contributing to health economics/outcomes research or reimbursement strategy.
- Existing network of relevant KOLs and investigators in the target therapeutic area.
Skills
- Clinical Science
- Scientific Affairs
- Clinical Evidence Strategy
- PMA Pathway
- IDE Strategy
- Pivotal Trial Design
- Clinical Protocols
- Investigator Brochures
- Clinical Investigation Plans
- Data Interpretation
- Evidence Synthesis
- Regulatory Submissions
- KOL Engagement
- Advisory Boards
- Publication Strategy
- Congress Strategy
- Medical Education
- Scientific Communication
- Health Economics
- Reimbursement Strategy
Experience Level
- Experienced VP
- Prior leadership of a clinical or scientific affairs function in a Series A–C company
Education Level
- Advanced degree (MD, PhD, PharmD, or equivalent) in a relevant scientific or clinical field
Salary/Compensations
- $260,000—$320,000 USD
Benefits
- Competitive compensation, including stock options.
- Comprehensive benefits package.
- 401(k) program with matching contributions.
About the Company
- Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions.
- Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life.
- Join a small, dedicated team of knowledgeable and motivated professionals.
- Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact.
- We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success.
Equal Opportunity
- Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.
