Executive Director, Regulatory CMC

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview
TheExecutive Director, Regulatory CMC leads an integrated group of regulatory CMC professionals, owns the regulatory CMC product portfolio strategy and is a member of the Regulatory Affairs Leadership Team. You will partner with functional heads of Technical Operations, Quality and Regulatory (e.g. Strategy, Operations & International) to ensure creation and timely delivery of science-based Quality documentation for Rhythm’s portfolio from development through post-approval.

You will serve as GRA’s senior strategic leader for regulatory CMC, providing enterprise-level leadership across the portfolio and guiding science-based, pragmatic Regulatory CMC strategies and risk-based decisions. Within and external to Rhythm, you will be a developing thought leader, building Rhythm’s presence within the broader regulatory CMC and Quality communities and advancing Rhythm’s priorities within the global regulatory environment. You will focus on team evolution by setting the tone for the group’s culture, developing talent and leadership capability, and ensuring the function continues to evolve with Rhythm’s portfolio and business needs.

Responsibilities and Duties

• Lead the Regulatory CMC function, setting priorities and providing strategic oversight across the portfolio, including regulatory strategy, risk assessment, optionality and outcomes. Provide appropriate senior-level review and approval of regulatory CMC documentation aligned with process.
• Represent Regulatory CMC in appropriate governance forums, bringing forward applicable considerations, risk assessment/mitigation, recommendations and influencing cross-functional portfolio decisions.
• Translate Rhythm’s corporate, portfolio, and patient priorities into clear Regulatory CMC priorities, build broader business acumen across the team and ensure the patient perspective is incorporated.
• Build and sustain network with key internal and external stakeholders, contributing to regulatory landscape assessments and advocating for Rhythm’s priorities with health authorities and/or industry associations.
• Anticipate and interpret changes within the global regulatory CMC / Quality environment, with a focus on ICH related markets, and advise internal stakeholders on potential portfolio impact, risks, and recommended actions.
• Provide senior Regulatory CMC leadership for key global health authority interactions, participating directly as needed, preparing team members for these engagements and ensuring consistent Regulatory CMC positions across the portfolio.
• Build and develop a high-performing Regulatory CMC team by setting clear expectations, coaching and developing talent, providing actionable feedback, and creating opportunities for team members to expand their leadership and strategic capabilities, aligned with Rhythm’s Values and Global Regulatory Affairs leadership principles.
• Set a forward-looking vision for the function, including the thoughtful adoption of automation, AI, and new ways of working to improve efficiency, elevate strategic contribution, and evolve team capabilities to meet business needs.
• Own functional resource planning, budget management, capability planning, and ensure appropriate processes, standards, training, and ways of working are in place to support the portfolio.
• Partner with Regulatory, Technical Operations, Quality, and other senior leaders to evaluate portfolio priorities, resource trade-offs, and CMC regulatory risks, recommending paths forward that balance scientific rigor, regulatory requirements, development timelines, and patient needs.

Qualifications and Skills

• Minimum of a Bachelor of Science degree (or equivalent) in a chemical, biological or mechanical science, with an advanced degree (e.g. PhD, MS, PharmD or MBA) preferred.
• Target of 20+ years of biopharmaceutical/pharmaceutical industry experience, with a minimum of 15+ years in regulatory CMC, with experience across relevant modalities (e.g. small molecule, biologics, vaccines, &/or devices) highly desired. Academic of other regulatory experience may be considered in lieu of regulatory CMC experience.
• Prior managerial experience, with a target of 10+ years leading global Regulatory CMC professionals or cross-functional teams as demonstrated by significant experience building, leading, and developing teams, including direct leadership and/or leadership of complex global cross-functional teams is expected.
• Prior experience as a research, manufacturing or quality scientist within the biotechnology or pharmaceutical industry is expected, with experience transferable to Regulatory CMC. Prior medical device experience or expertise is a plus.
• Demonstrated ability to influence complex cross-functional decisions, evaluate regulatory and enterprise risk, and build alignment around pragmatic, science-based recommendations.
• Recognized Regulatory CMC expertise in at least one ICH region, with significant experience across major global markets and demonstrated leadership of major global regulatory CMC submissions from strategy to approval.
• Demonstrated executive-level communication and influencing skills, with the ability to   tailor complex scientific and regulatory messages to different audiences and effectively negotiate with Health Authorities, specific FDA experience preferred.
• Demonstrated servant leader and coach with a track record of developing talent, empowering leaders, and holding team members accountable for outcomes.
• Role models Rhythm’s values – Patients at Core, Science-Driven, Stronger Together, Courageous, Respectful and Integrity.
• Fluent in English (written & spoken).

This role can be based in our corporate office in Boston, Massachusetts, remote US or select locations in Europe. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel and if remote based, travel to the Boston office is expected on a reasonable basis.

The expected salary range for this position is $230,000 - $330,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.

More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

At Rhythm our core values are:

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt
• We believe collaboration and ownership are foundational for our success
• We value the unique contribution each individual brings to furthering our mission

Inherent in our core values is the commitment to act ethically and with integrity in all we do.

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.