Rhythm Pharmaceuticals
Commercializes MC4R-targeted therapies for rare obesity
Associate Director - Device Development
+ Annual bonus + Restricted stock units
Hybrid role requiring attendance at the Boston office based on department and business needs; travel may be 10–20%.
About the job
- A bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline, with 8+ years of relevant experience.
- Experience in combination product or device development, including prefilled syringes and/or auto-injectors.
- Experience supporting late-stage development through commercialization.
- Strong knowledge of design controls, Design History Files, risk management under ISO 14971, human factors under IEC 62366, and verification and validation.
- Understanding of combination product regulations, including 21 CFR Part 4 and ISO 13485.
- Experience leading cross-functional teams in a matrixed environment.
- Strong problem-solving, communication, and stakeholder-influence skills.
- Strong program-management skills and ability to manage multiple priorities.
- Experience managing vendors or contract development and manufacturing organizations in regulated environments.
- Commitment to quality, compliance, and ethical standards.
- Willingness to travel 10–20%.
- Lead end-to-end development of combination products, such as prefilled syringes and auto-injectors, through commercialization.
- Define and execute device strategy, including design, verification, validation, and lifecycle management.
- Translate user needs into product requirements and executable development plans with defined milestones, timelines, and risk-mitigation strategies.
- Lead human-factors activities and integrate patient and provider insights.
- Identify and resolve device–drug interaction challenges.
- Own the Design History File and ensure compliance and inspection readiness.
- Serve as the subject matter expert for design controls and risk management in accordance with 21 CFR Part 4 and 820, ISO 13485, ISO 14971, and IEC 62366.
- Lead design controls, risk management including Failure Mode and Effects Analysis and hazard analysis, and change control.
- Support regulatory submissions and health-authority interactions.
- Ensure compliance with global combination-product regulations and standards.
- Support audits, inspections, and quality-system activities.
- Lead cross-functional teams across Chemistry, Manufacturing, and Controls, Regulatory, Quality, Clinical, and Supply Chain.
- Manage external vendors, contract development and manufacturing organizations, and development partners.
- Provide technical support for manufacturing, technology transfer, and lifecycle management.
- Communicate program status, risks, and decisions to stakeholders.
- Manage timelines, deliverables, and continuous-improvement efforts.
- An advanced degree such as a Master of Science or Doctor of Philosophy in Mechanical Engineering, Biomedical Engineering, or a related discipline.
- Experience with injectable drug–device interfaces and biologics delivery systems.
About the company
Rhythm Pharmaceuticals develops and commercializes therapies for rare neuroendocrine and genetic obesity disorders. Its lead drug, IMCIVREE (setmelanotide), is an MC4R agonist that helps restore signaling in the melanocortin-4 pathway to regulate hunger and energy use. The company earns revenue primarily from global IMCIVREE sales and reinvests in research, development, and commercialization. Its aim is to broaden MC4R-targeted treatments for underserved patients and advance additional candidates like bivamelagon and RM-718 through clinical development.
Company Size
201-500
Company Stage
IPO
Headquarters
Boston, Massachusetts
Founded
2008
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Simplify's Take
What believers are saying
- Second-quarter 2026 product revenue hit $71.3 million, up 19% sequentially.
- More than 400 acquired-HO start forms came from roughly 300 prescribers by June 30, 2026.
- AJ Joshi became chief medical officer on August 17, 2026, strengthening late-stage execution.
What critics are saying
- Rhythm depends on IMCIVREE; August 2026 revenue still came entirely from one drug.
- RM-718 and bivamelagon must succeed after 2026 data; failure leaves no next growth engine.
- Hypothalamic obesity launches in Japan and Europe need reimbursement speed; delays hit 2027 demand.
What makes Rhythm Pharmaceuticals unique
- Rhythm owns the only approved MC4R franchise for rare genetic obesity, built since 2008.
- IMCIVREE won Japan MHLW approval on August 24, 2026, extending global rare-obesity reach.
- Rhythm published a Bardet-Biedl diagnostic algorithm, improving patient identification for prescribers.
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Benefits
Hybrid Work Options
Performance Bonus
Company Equity
Growth & Insights and Company News
6 month growth
↑ 5%1 year growth
↑ 8%2 year growth
↑ 2%Stanley Druckenmiller's Duquesne Family Office disclosed new positions in over 40 stocks in its second quarter 13F filing. Notable healthcare investments included 203,618 shares of Rhythm Pharmaceuticals worth $22.6 million and 356,600 shares of Definium Therapeutics worth $16.8 million. Rhythm Pharmaceuticals develops treatments for hypothalamic obesity, currently the only approved drug for this condition. The company estimates approximately 10,000 US patients have acquired hypothalamic obesity, with similar numbers in Europe and 5,000 to 8,000 in Japan. Second-quarter revenue increased 47% year over year, whilst US revenue jumped 38% sequentially. The company remains unprofitable despite revenue growth and held $330.9 million in cash at quarter end, expected to fund operations for at least 24 months.
Rhythm Pharmaceuticals has received approval from Japan's Ministry of Health, Labour and Welfare for IMCIVREE (setmelanotide) to treat patients with acquired hypothalamic obesity (HO). This marks the first therapy approved in Japan for this condition. The approval was supported by the Phase 3 TRANSCEND trial involving 142 patients, including a Japanese cohort. The study met its primary endpoint with an 18.8% placebo-adjusted reduction in body mass index. Rhythm estimates 5,000 to 8,000 people are living with acquired HO in Japan. The company expects to launch IMCIVREE before the end of 2026, pending final pricing determination. Acquired HO is characterised by accelerated weight gain following hypothalamic injury, often resulting from craniopharyngioma, astrocytoma, or other hypothalamic-pituitary tumours.
Rhythm Pharmaceuticals has appointed Manher "AJ" Joshi as Chief Medical Officer, effective 17 August. Dr Joshi brings over 20 years of experience spanning drug discovery, pivotal trials, regulatory processes and lifecycle management. Dr Joshi joins from Soleno Therapeutics, where he served as Chief Development Officer. He previously held the Chief Medical Officer position at Neurona Therapeutics and executive roles at Atara Biotherapeutics. His career also includes leadership positions at Allergan Medical, Synageva BioPharma, and Genzyme. Rhythm is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases. Its lead asset, IMCIVREE (setmelanotide), is approved in the US and Europe for treating certain forms of obesity. The company is advancing next-generation MC4R agonists through late-stage development.
Rhythm Pharmaceuticals announced that the UK's Medicines and Healthcare products Regulatory Agency has expanded the marketing authorisation for IMCIVREE (setmelanotide) to include treatment of obesity and control of hunger in adults and children aged 4 and older with acquired hypothalamic obesity due to hypothalamic injury or impairment. The MHRA also granted IMCIVREE orphan drug designation for acquired HO. The approval is based on results from the Phase 3 TRANSCEND trial, which met its primary endpoint with a statistically significant 19.8% placebo-adjusted reduction in body mass index. The global trial enrolled 120 patients. IMCIVREE initially received marketing authorisation in the UK in 2021 for treatment of obesity in patients with POMC, PCSK1 or LEPR deficiency, with subsequent expansions for other rare obesity conditions.
Rhythm Pharmaceuticals reported preliminary results showing its experimental weekly injectable drug RM-718 helped reduce body weight in patients with acquired hypothalamic obesity, a rare condition caused by brain damage from tumour surgery or treatment. The Boston-based company's shares rose 5% in premarket trading. Among 11 enrolled patients, seven who completed 16 weeks of treatment saw their body mass index fall by an average of 11.6%. The drug works by activating the MC4R brain receptor, which controls hunger and metabolism. Two patients discontinued treatment due to side effects including nausea and injection site problems. Rhythm also sells setmelanotide for the same condition under the brand name Imcivree. Separately, the company reported second-quarter revenue of $71.3 million, up 46.9% from $48.5 million a year earlier.