VP, Clinical Development — Sleep Medicine & Regulatory Strategy

Apnimed; Cambridge (MA); On-site; USD 350,000 - 750,000; Full time

Benefits offered by this job

401(k) with company match

Generous time off for vacation

Flexible working environment

Motivated and experienced team

Winner of 2024 Boston Business Journal

Job summary

Apnimed is seeking a Senior Director/Vice President, Clinical Development to lead the design and execution of clinical trials across programs from early-phase through late-stage, in support of regulatory submissions. The successful candidate will shape clinical development strategy and partner with cross-functional teams and external vendors to deliver high-quality, regulatory-ready data.

This is an exciting opportunity to be at the forefront of sleep apnea treatment advancement.

Qualifications

• MD or equivalent in life sciences with board certification in a relevant area preferred.
• 12+ years of clinical development experience in biopharma, leading programs from early development to regulatory submission.
• Deep expertise in trial design, GCP, and regulatory frameworks (FDA/EMA/ICH).
• Experience managing data strategies and CRO/vendor collaborations to deliver regulatory-ready data.
• Proven ability to lead cross-functional teams in a fast-paced, mission-driven environment.

Responsibilities

• Provide scientific and operational leadership for assigned clinical programs from early phase to late-stage, including post-marketing.
• Lead clinical development plans and trial protocols aligned with regulatory and scientific standards.
• Oversee study planning, timelines, budgets, and decisions on in‑house vs. CRO partnerships.
• Oversee data management strategy to ensure data integrity for regulatory filings.
• Ensure compliance with GCP and regulatory requirements; contribute to IND/NDA submissions.
• Collaborate with regulatory, preclinical, medical affairs, and commercial teams to align strategy.
• Recruit, mentor, and develop a high-performing clinical development team.
• Represent Apnimed with investigators, regulators, and partners to advance programs.

Skills

Clinical development leadership

Regulatory submissions

Cross-functional leadership

GCP/regulatory knowledge

Trial design and execution

Vendor management

Education

MD or equivalent in life sciences

Job description

Apnimed is seeking a Senior Director/Vice President, Clinical Development to lead the design and execution of clinical trials across programs from early-phase through late-stage, in support of regulatory submissions. The successful candidate will shape clinical development strategy and partner with cross-functional teams and external vendors to deliver high-quality, regulatory-ready data.

This is an exciting opportunity to be at the forefront of sleep apnea treatment advancement.