Chief Medical Officer, Development

Akebia Therapeutics; Cambridge, Greater Manchester; On-site; USD 409,000 - 506,000; Full time

Job summary

An established industry player is seeking a dynamic Chief Medical Officer to drive clinical and regulatory strategies for innovative products. This pivotal role involves overseeing NDA filings, optimizing clinical trials, and ensuring patient safety while leading high-performing teams. With over 15 years of biopharmaceutical development experience and a strong background in renal, hematology, or cardiovascular diseases, the ideal candidate will thrive in a collaborative environment. Join a forward-thinking company committed to making a difference in the lives of those affected by kidney disease, offering a competitive compensation package and a chance to shape the future of healthcare.

Qualifications

• 15+ years in biopharmaceutical development with leadership experience.
• Global experience in clinical development and regulatory approval.

Responsibilities

• Provide strategic leadership in product development.
• Lead clinical and regulatory initiatives, ensuring patient safety.

Skills

Biopharmaceutical Development

Leadership

Clinical Strategy

Regulatory Submissions

Communication Skills

Cross-Functional Relationships

Education

MD

Job description

Chief Medical Officer, Development

Location: Cambridge, MA

Type: Full-Time/Regular

Job ID: 25R-17

Akebia Therapeutics is seeking a dynamic and strategic Chief Medical Officer (CMO) to lead its development programs, including Auryxia, Vafseo, praliciguat, and others. The CMO will drive clinical and regulatory strategy, oversee NDA filings, and shape the company's future.

Key Responsibilities:

1. Provide strategic leadership in product development in collaboration with the CEO, Board, and executive team.
2. Lead clinical and regulatory initiatives, including protocol development and regulatory submissions.
3. Develop clinical strategies supporting product launches and pipeline assets.
4. Optimize clinical trials for efficacy, safety, timelines, and costs.
5. Ensure patient safety and manage pharmacovigilance activities.
6. Represent Akebia with regulators, advisory committees, and external stakeholders.
7. Build and lead Clinical Advisory Boards.
8. Partner with commercial teams to communicate product value.
9. Serve as a spokesperson at scientific and investor events.
10. Advise on business development opportunities.
11. Attract and develop high-performing clinical and regulatory teams.

Basic Qualifications:

• 15+ years in biopharmaceutical development
• 10+ years in leadership roles
• MD required
• Experience in renal, hematology, or cardiovascular diseases
• Global experience in clinical development and regulatory approval

Preferred Qualifications:

• Understanding of late-stage product development and GXP
• Excellent communication skills
• Ability to build cross-functional relationships

Compensation: Targeted base salary $409,260 - $505,556, plus bonuses, equity, and benefits.

Join us to make a difference in the lives of those affected by kidney disease. Visit www.akebia.com to learn more.

Akebia is an equal opportunity employer.