Full-Time
Associate Director
Multiple Teams
Rhythm Pharmaceuticals
201-500 employees
Commercializes MC4R-targeted therapies for rare obesity
Compensation Overview
$160k - $240k/yr
Boston, MA, USA
Hybrid
Hybrid work requires attendance at the Boston office based on department and business needs; travel up to 25% may be required.
Bachelor's
 Biology & Biotech (1) |
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- 5+ years of Good Clinical Practice-related Quality Assurance or relevant clinical trial experience.
- Experience supporting Regulatory Authority Good Clinical Practice Inspections.
- Extensive knowledge and/or awareness of International Council for Harmonisation Good Clinical Practice and applicable global regulations and guidance for clinical development.
- Excellent communication, writing, and presentation skills for effectively interfacing with internal and external stakeholders.
- Strong judgment, project management, and decision-making skills; able to manage multiple projects and demanding timelines.
- Demonstrated ability to work independently and in a team environment.
- Ability to assess complex issues, propose viable solutions, and follow through to resolution.
- Demonstrated ability to organize cross-functional teams and execute on aligned tactics.
- Ability to foster effective relationships with vendors, investigators, and colleagues.
- Willingness to travel up to 25% to various meetings and/or audits, including overnight trips; some international travel may be required.
- Provide Good Clinical Practice oversight, collaborate cross-functionally, and provide guidance to Good Clinical Practice functional groups supporting clinical studies.
- Oversee the vendor management program, create and manage study-specific Clinical Audit Plans, and interact with contract auditors to facilitate the audit process with internal and external stakeholders.
- Proactively identify compliance issues and risks and recommend mitigations.
- Draft, review, revise, or provide input to standard operating procedures to assess consistency and compliance with regulatory requirements and internal standards.
- Manage Rhythm's Quality Management System for Clinical Quality Assurance activities, including development and management of controlled documents and training matrices, audits, corrective and preventive actions, deviations, and related documentation.
- Develop and deliver Good Clinical Practice training, including continuous training activities such as webinars, lunch-and-learn sessions, and compliance updates.
- Lead or assist with Good Clinical Practice health authority inspections, support clinical-team inspection preparation, provide technical compliance support during inspections of vendors, clinical investigator sites, and Rhythm, and facilitate timely inspection responses and follow-up actions.
- Review key safety, clinical, and regulatory documents, including protocols, amendments, Informed Consent Forms, Clinical Study Reports, Development Safety Update Reports, Investigator's Brochures, Investigational New Drug applications, and New Drug Applications.
- Collaborate cross-functionally and with external parties to promote quality and consistency across clinical programs and identify and mitigate Good Clinical Practice quality and compliance issues.
- Escalate systemic and critical problems and recommend appropriate immediate and long-term solutions.
- Train and mentor employees on global Good Clinical Practice regulations and guidance as needed.
- A Bachelor's Degree in a clinical/scientific field is preferred.
- Knowledge of Good Laboratory Practice and Good Pharmacovigilance regulations is a plus.
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.