Full-Time
Senior Director
Clinical Pharmacology
Amylyx Pharmaceuticals
51-200 employees
Biopharmaceutical company developing neurodegenerative therapies
Compensation Overview
$268k - $302k/yr
Cambridge, MA, USA
Remote
Remote within the United States, with travel to Cambridge several times a year. Applicants residing or working in Alaska, Arizona, Hawaii, Michigan, or Tennessee are not considered.
PharmD, PhD, MD
 Biology & Biotech (1) |
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- A PhD, Doctor of Pharmacy, Doctor of Medicine, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, or a related scientific discipline is required.
- Approximately 10–15 or more years of pharmaceutical or biotechnology industry experience, including significant experience supporting clinical drug development, is required.
- At least 10 years of direct Clinical Pharmacology experience is required.
- Experience supporting multiple clinical development stages, including early- and late-stage development, is required.
- Experience preparing regulatory submissions and interacting with the Food and Drug Administration and other global health authorities is required.
- Serve as the Clinical Pharmacology lead for assigned development programs from first-in-human studies through Phase 3 clinical trials.
- Develop and execute program-specific clinical pharmacology strategies aligned with overall development objectives.
- Provide scientific leadership for pharmacokinetics, pharmacodynamics, exposure-response, population pharmacokinetics, modeling, and simulation activities.
- Design and oversee clinical pharmacology studies, including protocol development, analysis plans, interpretation of results, and reporting.
- Collaborate with cross-functional teams to integrate clinical pharmacology into broader development strategies.
- Partner with Clinical Development physicians, statisticians, pharmacometricians, Regulatory Affairs, Biometrics, and Medical Writing to support program execution.
- Interpret clinical pharmacology data and translate findings into clear scientific and regulatory recommendations.
- Contribute to dose selection, dose optimization, labeling strategy, and benefit-risk assessments.
- Support preparation of regulatory submission documents, including Investigational New Drug applications, briefing books, Common Technical Documents, clinical pharmacology summaries, and responses to health authority questions.
- Participate in regulatory agency meetings as a clinical pharmacology subject matter expert.
- Manage external contract research organizations, consultants, and pharmacometric vendors supporting assigned programs.
- Stay current on emerging clinical pharmacology methodologies, regulatory expectations, and industry best practices.
- Contribute to scientific publications, presentations, and internal knowledge sharing.
- Mentor junior scientists and provide technical guidance across project teams as appropriate.
- Experience with biologics, peptides, small molecules, or gene therapies.
- Strong understanding of pharmacokinetic/pharmacodynamic principles and clinical pharmacology strategy.
- Experience with population pharmacokinetics and exposure-response analyses.
- Familiarity with pharmacometric modeling and simulation approaches.
- Working knowledge of NONMEM, Phoenix WinNonlin, R, SAS, or comparable clinical pharmacology software.
- Scientific writing and presentation skills.
- Ability to independently interpret complex clinical data and communicate recommendations to senior leadership.
- Project management and organizational skills.
- Success working in highly collaborative, cross-functional environments.
- Ability to manage multiple programs simultaneously in a fast-paced biotechnology environment.
Amylyx Pharmaceuticals develops treatments for neurodegenerative diseases, with a focus on ALS and Alzheimer's disease. Its main asset is AMX0035, currently in clinical trials, including the CENTAUR study for ALS and the PEGASUS study for late mild cognitive impairment or early dementia due to Alzheimer’s disease. The company advances products through rigorous, randomized, double-blind, placebo-controlled trials to demonstrate safety and efficacy before pursuing commercialization. In addition to research, Amylyx engages in awareness and community campaigns to support patients, caregivers, and researchers. The company aims to bring validated therapies to market to improve patient outcomes and generate revenue by selling treatments to healthcare providers and patients.
Company Size
51-200
Company Stage
IPO
Headquarters
Cambridge, Massachusetts
Founded
2013
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Simplify's Take
What believers are saying
- LUCIDITY on August 18, 2026 cut serious hypoglycemia events 55%.
- Amylyx priced a $500.2 million offering on August 20, 2026.
- Management targets an NDA by year-end 2026 and launch in 2027.
What critics are saying
- Relyvrio vanished in April 2024, proving Amylyx can lose approved revenue overnight.
- Avexitide rests on 78 patients, leaving FDA review and reimbursement concentrated.
- If avexitide fails, Amylyx becomes a cash-burning shell after Relyvrio's exit.
What makes Amylyx Pharmaceuticals unique
- Avexitide is first-in-class for post-bariatric hypoglycemia, with no FDA-approved competitors.
- FDA-agreed LUCIDITY endpoints and breakthrough designations reduce regulatory ambiguity.
- Amylyx runs endocrine and neurodegeneration programs, not a single-asset company.
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Growth & Insights and Company News
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↓ -13%Amylyx Pharmaceuticals announces pricing of an upsized $500 million underwritten public offering of common stock. Foto: adobe.stock.com Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) ("Amylyx" or the "Company") today announced the pricing of an upsized underwritten public offering of 14,090,000 shares of its common stock at a public offering price of $35.50 per share. In addition, Amylyx has granted the underwriters a 30-day option to purchase up to an additional 2,113,500 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. All of the shares of common stock are being offered by Amylyx. The gross proceeds to Amylyx from this offering are expected to be $500.2 million, before deducting underwriting discounts and commissions and offering expenses and excluding any exercise of the underwriters' option to purchase additional shares. Amylyx intends to use the net proceeds from this offering, together with existing cash, cash equivalents and marketable securities, for: * Pre-commercial activities for avexitide, including securing additional manufacturing capacity; * Research and development; and * Working capital and other general corporate purposes. The offering is expected to close on or about August 21, 2026, subject to the satisfaction of customary closing conditions. Leerink Partners, Morgan Stanley, Guggenheim Securities and LifeSci Capital are acting as joint bookrunning managers for the offering. The shares described above are being offered pursuant to a shelf registration statement on Form S-3ASR (File No. 333-293956) that became automatically effective upon filing with the Securities and Exchange Commission (the "SEC") on March 3, 2026. This offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC on August 18, 2026, and are available on the SEC's website located at www.sec.gov. A final prospectus supplement containing additional information relating to the offering and accompanying prospectus will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting: Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: (212) 518-9544, email: [email protected]; and LifeSci Capital LLC, Attention: LifeSci Capital LLC, 1700 Broadway, 40th Floor, New York, NY 10019, or by email at [email protected]. Business Wire (engl.) Autor folgen Verfasst von Letzte Änderung20.08.2026, 05:06 Im Artikel enthaltene Werte
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has commenced an underwritten public offering of $350.0 milli...
AMLX stocks surge 64% on positive avexitide trial data, launches $350M offering. 2026-08-18 14:39:33 Key takeaways. * Amylyx Pharmaceuticals announced positive LUCIDITY trial data for avexitide and launched a $350 million public offering on Tuesday. * The late-stage trial demonstrated a 55% reduction in serious hypoglycemia events with a clean safety profile in 78 patients. * Amylyx plans to file for U.S. FDA approval by end of 2026 and aims for a 2027 market launch if approved. Amylyx Pharmaceuticals (AMLX) launched a $350 million underwritten public offering of common shares after hours on Tuesday, following the announcement of positive topline data from its late-stage LUCIDITY trial of avexitide for post-bariatric hypoglycemia. The stock closed 64% higher on Tuesday, marking its best single-day performance, and edged up 2% after hours. The capital raise will fund pre-commercial work for avexitide, including additional manufacturing capacity, research and development, and general corporate needs. Post-bariatric hypoglycemia is a rare condition causing repeated dangerous drops in blood sugar after weight-loss surgery. Amylyx has no FDA-approved therapies as of August, after its previously approved product Relyvrio was withdrawn from the market following a failed late-stage trial in 2024. LUCIDITY trial shows 55% reduction in serious hypoglycemia events. The late-stage LUCIDITY study evaluated avexitide, a once-daily injection, in 78 patients with post-bariatric hypoglycemia. Avexitide reduced the rate of serious low-blood-sugar events by 55% compared with placebo. The trial met every secondary endpoint with clear, meaningful reductions and demonstrated a clean safety profile. Amylyx plans to file for U.S. approval by the end of 2026 and aims for a 2027 launch if approved. Amylyx launches $350M public offering to fund avexitide commercialization. Amylyx announced the underwritten public offering after hours on Tuesday. Proceeds from the offering, combined with existing cash, will support pre-commercial activities for avexitide, including expansion of manufacturing capacity, research and development efforts, and general corporate purposes. The offering is subject to market conditions. The capital raise positions the company to transition from clinical success toward potential commercialization following the positive LUCIDITY trial results. Analysts raise price targets following trial data. H.C. Wainwright raised its price target on Amylyx to $55 from $34 and maintained a Buy rating. The firm stated that the LUCIDITY results substantially de-risk avexitide, citing the 55% reduction in events, strong secondary outcomes, clean safety profile, and a planned year-end filing that supports a 2027 launch and approximately $1.3 billion in risk-adjusted peak U.S. sales. Stifel lifted its price target to $45 from $21 and kept a Buy rating. The firm described the data as a "best-case scenario" and "clear win" on the primary endpoint with clean safety, stating the results substantially de-risk approval and shift focus to commercial execution in a market estimated at $2 billion. Citi described avexitide's profile as "highly differentiated" and said the company now has a "persuasive foundation" for FDA approval. Citi maintained a Buy rating with a $32 price target. Retail sentiment shifts to extremely bullish on Stocktwits. On Stocktwits, retail sentiment around AMLX stock rose from neutral to extremely bullish territory over the past 24 hours, while message volume increased from normal to extremely high levels. One Stocktwits user expressed hopes for a further rally up to $40 per share. Another user commented that dilution risk is now offset after the stock offering. AMLX stock has gained approximately 200% year-to-date. Faq. What were the results of Amylyx's LUCIDITY trial for avexitide? The late-stage LUCIDITY trial in 78 patients showed that avexitide reduced the rate of serious low-blood-sugar events by 55% compared with placebo. The trial met all secondary endpoints with meaningful reductions and demonstrated a clean safety profile. When does Amylyx plan to file for FDA approval of avexitide? Amylyx plans to file for U.S. approval by the end of 2026 and aims for a 2027 launch if approved. How much capital did Amylyx raise in its public offering? Amylyx launched an underwritten public offering of $350 million in common shares after hours on Tuesday. The proceeds will fund pre-commercial work for avexitide, including manufacturing capacity expansion, research and development, and general corporate needs. Disclaimer: The information on this page may come from third-party sources and is for reference only. It does not represent the views or opinions of Gate and does not constitute any financial, investment, or legal advice. Virtual asset trading involves high risk. Please do not rely solely on the information on this page when making decisions. For details, see the Disclaimer.
Amylyx Pharmaceuticals has launched an underwritten public offering of $350 million in common stock. The company also plans to grant underwriters a 30-day option to purchase up to an additional $52.5 million worth of shares. Amylyx intends to use the net proceeds, along with existing cash and securities, for pre-commercial activities for avexitide, including securing additional manufacturing capacity, research and development, and general corporate purposes. Leerink Partners, Morgan Stanley, Guggenheim Securities, and LifeSci Capital are serving as joint bookrunning managers for the offering. The shares are being offered under a shelf registration statement filed with the Securities and Exchange Commission on 3 March 2026. The offering is subject to market conditions, with no assurance regarding completion or final terms.
Amylyx Pharmaceuticals' stock jumped 56% to $32.26 after its drug candidate avexitide met both primary and secondary endpoints in a Phase 3 trial for post-bariatric hypoglycemia. The LUCIDITY trial showed avexitide reduced severe hypoglycemic events by 55% compared with placebo, exceeding the 35% threshold set by regulators. Post-bariatric hypoglycemia affects approximately 8% of people who have undergone certain gastric bypass surgeries in the US, roughly 160,000 people. The condition causes rapid blood glucose drops leading to confusion, loss of consciousness, and seizures. No FDA-approved treatments currently exist. Amylyx plans to submit a New Drug Application by end of 2026, targeting a 2027 commercial launch. The company acquired avexitide for $35 million through Eiger BioPharmaceuticals' 2024 bankruptcy proceedings.