Senior Director / Vice President Clinical Development

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 a rapidly growing pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea (OSA) could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program, AD109, targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Apnimed is committed to innovation, as well as state‑of‑the‑art advancements in sleep medicine, which is leading to the development of a portfolio of novel pharmacologic therapies for sleep apnea and related disorders.

Recognized by the Boston Business Journal as one of the Best Places to Work in both 2024 and 2025, we are continuing to grow and build the foundational operations that enable our employees and our mission to thrive.

Summary:

The Senior Director/Vice President, Clinical Development reports to the Chief Medical Officer and is responsible for leading the design and execution of clinical trials across Apnimed's development programs, from early-phase through late-stage studies, in support of regulatory submissions and approvals. The successful candidate will also play a key role in shaping clinical development strategy and partnering 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 a major paradigm shift in the treatment of sleep apnea from medical devices and surgery to a first in class pharmaceutical treatment.

The posted salary range reflects the full scope of levels for this role. Final compensation will depend on the selected candidate’s level, education and experience.

Key Job Duties include, but are not limited to:

• Provide scientific and operational leadership for assigned clinical programs, overseeing clinical trials from early‑phase development through late‑stage studies and post‑marketing programs.
• Lead the development of clinical development plans and trial protocols, ensuring alignment with regulatory, ethical, and scientific standards.
• Oversee the planning and execution of clinical studies, including timelines and budgets, and decisions on in‑house execution versus third‑party partnerships (e.g., CROs).
• Oversee clinical data management strategy and activities to ensure data integrity and support regulatory filings.
• Ensure all clinical research activities comply with GCP and applicable global regulatory requirements, and contribute to regulatory submissions and health authority interactions (e.g., IND, NDA).
• Collaborate cross‑functionally with regulatory, preclinical, medical affairs, and commercial teams to align clinical development with broader corporate strategy.
• Recruit, mentor, and develop a high‑performing clinical development team.
• Represent Apnimed externally with investigators, regulators, and strategic partners to advance clinical programs and build credibility within the scientific and medical communities.

Qualifications:

• Medical degree (MD) or equivalent in the life sciences; board certification in a relevant therapeutic area (e.g., sleep medicine, neurology, pulmonology) strongly preferred.
• 12+ years of clinical development experience in the biopharmaceutical industry, including leading programs from early development through Phase III and regulatory submission.
• Deep understanding of clinical trial design, execution, GCP, and regulatory frameworks (FDA, EMA, ICH).
• Experience managing data management strategies and working with internal teams and external vendors (including CROs) to deliver high‑quality, regulatory‑ready data.
• Experience contributing to regulatory submissions (e.g., IND, NDA) and interacting with health authorities.
• Proven ability to lead and collaborate within cross‑functional teams in a fast‑paced, mission‑driven environment.
• Demonstrated leadership skills, with the ability to influence both internal and external stakeholders.
• Ability to manage simultaneous priorities and changing deadlines.
• Excellent oral and written communication skills.
• Ability to plan, organize and prioritize work.

What Apnimed Offers:

• 401(k) with company match
• Generous time off for vacation
• Flexible working environment
• Motivated and experienced team
• Winner of 2024 Boston Business Journal Best Places to Work

Location and Other Information:

• Apnimed is a publicly licensed company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical.
• We are a small growing Company with an inclusive environment.
• Must be able to travel as necessary.
• Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment.
• Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea.