Senior Director - Analytical Development & Quality Control
About the job
- A PhD (preferred) or MS in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
- At least 12 years of analytical development experience in the pharmaceutical or biotechnology industry for PhD holders, or equivalent experience, including significant leadership experience.
- Demonstrated experience leading analytical development and QC organizations supporting small molecule and/or peptide drug development across the lifecycle, from discovery through commercialization.
- Deep expertise in analytical method development, validation, transfer, and lifecycle management.
- Strong knowledge of small molecule and/or peptide analytical techniques, including chromatography (HPLC/UPLC), mass spectrometry, impurity analysis, stability, and characterization.
- Extensive experience with control strategy development, specification setting, comparability, and regulatory-ready analytical packages.
- Proven experience overseeing stability programs, impurity tracking, and reference standard programs.
- Familiarity with quality management systems and procedures for change management, investigations, deviations, and document control.
- Strong understanding of cGMP, data integrity principles, and ICH guidelines.
- Demonstrated experience supporting global regulatory submissions (IND, IMPD, NDA, MAA) and regulatory inspections.
- Proven ability to lead cross-functional teams and influence decision-making in a matrixed organization.
- Strong external vendor management experience, including CDMOs and CRO oversight in a virtual environment.
- Track record of managing complex programs, solving technical and regulatory challenges, and delivering under aggressive timelines.
- Excellent communication and presentation skills, with the ability to convey complex technical information to diverse stakeholders.
- Strong strategic thinking, problem-solving, and risk management capabilities.
- Ability to manage multiple priorities in a fast-paced, dynamic, and highly collaborative environment.
- Must be willing and able to work in the Boston office in coordination with department and business needs.
- Define and execute end-to-end analytical strategies across the product lifecycle, including method development, validation, transfer, and lifecycle management from raw materials through drug substance and drug product.
- Establish phase-appropriate control strategies, specifications, and analytical approaches aligned with regulatory expectations and commercial readiness.
- Drive innovation in analytical technologies and methodologies, translating new approaches into robust, scalable platforms for development and commercial testing.
- Lead product characterization strategies, including identification and control of critical quality attributes (CQAs), impurity profiling, comparability, and stability programs.
- Act as Head of Quality Control for analytical testing supporting US and EU market authorization holders (MAHs), ensuring compliant release and support of clinical and commercial products.
- Oversee QC testing activities, including in-process, release, stability, reference standards, and impurity monitoring programs for drug substance and drug product.
- Ensure internal and external laboratories operate in compliance with cGMP, data integrity, and global regulatory requirements.
- Provide oversight for investigations, deviations, OOS/OOT results, complaints, and root cause analyses, ensuring timely and compliant resolution.
- Lead and manage analytical development and QC activities executed by CDMOs, CROs, and contract laboratories, ensuring quality, timelines, and cost objectives are met.
- Oversee analytical method transfer activities, including protocol design, execution, and performance monitoring across internal and external sites.
- Establish and manage budgets, resource plans, timelines, and risk mitigation strategies across programs.
- Build and maintain supplier relationships and oversee regulatory inspections and audit readiness of external laboratories.
- Provide strategic leadership for regulatory submission activities, including authoring, reviewing, and approving Module 3 analytical sections for INDs, IMPDs, NDAs, MAAs, and lifecycle filings.
- Lead analytical responses to health authority queries and represent the function during regulatory interactions and inspections.
- Ensure analytical development activities align with ICH guidelines and global regulatory expectations.
- Partner with Drug Substance, Drug Product, Regulatory Affairs, Quality Assurance, Manufacturing, Project Management, and Research functions to advance development programs.
- Serve as analytical subject matter expert on cross-functional CMC and Product Development Teams.
- Influence strategic decision-making and drive alignment across internal stakeholders and senior leadership.
- Build, lead, and develop a high-performing analytical development and QC organization, including hiring, coaching, mentoring, and succession planning.
- Foster a culture of scientific excellence, innovation, accountability, and continuous improvement.
- A PhD in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
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
501-1,000
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
1%1 year growth
8%2 year growth
2%Rhythm Pharmaceuticals has launched IMCIVREE (setmelanotide) in Japan to treat acquired hypothalamic obesity. It is the first approved therapy for the condition in the country, and it is now on Japan's National Health Insurance drug price list. Japan's Ministry of Health, Labour and Welfare approved the drug in August. The approval rested on the Phase 3 TRANSCEND trial of 142 patients, which met its primary endpoint with an 18.8% placebo-adjusted reduction in body mass index. Rhythm, based in Boston, estimates that 5,000 to 8,000 people in Japan live with the condition. "This launch marks an important advancement for people living with acquired HO in Japan," said Yann Mazabraud, executive vice president and head of international at Rhythm.
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.