Associate Director, Drug–Device Development Leader

Rhythm Pharmaceuticals, Inc; Boston (MA); Hybrid; USD 160,000 - 240,000; Full time

Benefits offered by this job

Discretionary annual bonus

RSUs

Job summary

Rhythm Pharmaceuticals, Inc. seeks an Associate Director to lead the development and lifecycle management of drug–device combination products, focusing on injectable delivery systems like prefilled syringes and auto‑injectors.

You will own DHF, drive design controls, and coordinate across CMC, regulatory, clinical, and manufacturing functions. Based in our Boston office with a hybrid work model, you will lead cross‑functional teams and external partners to ensure safe, patient‑centric delivery

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering with 8+ years of relevant experience.
• Experience in combination product/device development (prefilled syringes and/or auto‑injectors).
• Experience supporting late‑stage development through commercialization.

Responsibilities

• Lead end-to-end development of combination products through commercialization.
• Define device strategy, including design, verification, validation, and lifecycle management.
• Translate user needs into product requirements with defined milestones, timelines, and risk mitigation strategies.
• Lead human factors activities and integrate patient/provider insights.
• Own Design History File (DHF) and ensure compliance and inspection readiness.
• Lead design controls, risk management and change control; support regulatory submissions.
• Manage cross‑functional teams and external partners; communicate program status and decisions.

Education

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline

Advanced degree (MS or PhD) preferred

Job description

Rhythm Pharmaceuticals, Inc. seeks an Associate Director to lead the development and lifecycle management of drug–device combination products, focusing on injectable delivery systems like prefilled syringes and auto‑injectors.

You will own DHF, drive design controls, and coordinate across CMC, regulatory, clinical, and manufacturing functions. Based in our Boston office with a hybrid work model, you will lead cross‑functional teams and external partners to ensure safe, patient‑centric delivery