Full-Time

Associate Director/Director

Development Program Management, CMC

Xenon Pharmaceuticals

Xenon Pharmaceuticals

201-500 employees

Clinical-stage neurological disorder therapeutics developer

Compensation Overview

$176.9k - $246.8k/yr

+ Target bonus + Stock options

Boston, MA, USA + 1 more

More locations: Needham, MA, USA

Hybrid

Hybrid positions require a minimum of two onsite days per week. Exceptional candidates may be considered for remote locations.

Bachelor's

Category
Project & Program Management (1)
Required Skills
Microsoft Office
Data Visualization
REST APIs

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Requirements
  • A bachelor's degree in a scientific, technical, business, or related discipline is required.
  • Typically, 8+ years of relevant biotechnology or pharmaceutical industry experience is required for the Associate Director level, or 10+ years for the Director level, including significant experience in CMC, pharmaceutical development, technical operations, or related drug development environments.
  • Experience supporting small molecule drug substance and drug product development is required.
  • Demonstrated experience managing cross-functional CMC deliverables, timelines, risks, and documentation in support of early-stage regulatory submissions, including Investigational New Drug applications and/or Investigational Medicinal Product Dossiers.
  • Proven ability to influence without authority, drive alignment across technical and non-technical stakeholders, and ensure execution discipline across complex, matrixed development teams.
  • Experience developing and maintaining CMC-specific project plans, dashboards, milestone charts, action logs, risk logs, and related project management tools.
  • Strong analytical, facilitation, problem-solving, written communication, and verbal communication skills, with the ability to communicate effectively with both technical and non-technical stakeholders.
  • Proficiency with Smartsheet, Microsoft Project, Microsoft Office, and related project management tools is required.
Responsibilities
  • Plan and manage budget proposals and approved budgets in accordance with the company's strategic and operating plans and Finance policies.
  • Partner with CMC, Development Program Management, Program Team Leaders, and functional stakeholders to translate program strategy into integrated CMC execution plans, project charters, and team ways of working for assigned programs and initiatives.
  • Lead project management for assigned CMC activities, including new molecules, technology transfer, scale-up, lifecycle management, and other development initiatives, ensuring alignment of scope, timelines, milestones, dependencies, deliverables, and risks.
  • Develop, baseline, and maintain project management tools and reporting, including CMC project plans, dashboards, milestone charts, action logs, risk logs, status reports, and financial tracking, as appropriate.
  • Drive team execution and governance through effective meeting management, decision and action documentation, follow-up with accountable owners, and clear communication of progress, risks, issues, and key decisions.
  • Monitor project progress, identify risks or execution gaps, and partner with stakeholders to develop mitigation plans, escalation recommendations, and decision-ready updates.
  • Improve CMC project management effectiveness through scalable tools, templates, Smartsheet solutions, automation, artificial intelligence-enabled approaches, and other process improvements that enhance planning, visibility, and execution.
  • Act in accordance with company policies, including the Code of Business Conduct and Ethics, and ensure policies are understood and followed by direct reports, if any.
  • Perform some international travel as required.
  • Perform other duties as assigned.
Desired Qualifications
  • An advanced degree is preferred.
  • Experience with application programming interface development and solid oral dosage forms is strongly preferred.
  • Exposure to New Drug Application, Marketing Authorization Application, or other late-stage submission activities is preferred.
  • Project Management Professional certification or equivalent project management training is preferred.
Xenon Pharmaceuticals

Xenon Pharmaceuticals

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Xenon develops therapies for neurological disorders, especially epilepsy, in a clinical-stage biopharma setting, using research, partnerships, and licensing to move candidates toward commercialization. Its products are designed to act on neurological and genetic targets, with XEN007 in Phase 2 for treatment-resistant pediatric absence epilepsy illustrating its development pathway and reliance on clinical testing. The company differentiates itself by focusing on genetics-informed neurology and a pediatric, targeted epilepsy pipeline supported by collaborations rather than broad, one-size-fits-all approaches. The goal is to discover, develop, and eventually bring to patients therapies that address unmet neurological needs, advancing outcomes through a strong clinical pipeline and strategic partnerships.

Company Size

201-500

Company Stage

IPO

Headquarters

Burnaby, Canada

Founded

1996

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Simplify Jobs

Simplify's Take

What believers are saying

  • August 2026 Q2 cash reached $1.245 billion, funding operations into 2029.
  • August 2026 pre-NDA meeting kept azetukalner NDA submission on track for Q3 2026.
  • March 2026 X-TOLE2 results supported potential first approval in focal onset seizures.

What critics are saying

  • Xenon remains pre-revenue and lost $110.7 million in Q2 2026.
  • August 2026 pipeline still depends on one asset; azetukalner failure would cripple valuation.
  • March 2026 equity raises and warrants diluted holders; more financing follows if launch slips.

What makes Xenon Pharmaceuticals unique

  • Azetukalner is Xenon's lead KV7 opener, with positive Phase 3 X-TOLE2 data.
  • Only drug in late-stage epilepsy and neuropsychiatry simultaneously, spanning seizures, MDD, bipolar depression.
  • Neurocrine collaboration on NaV1.6 strengthens channel-drug expertise and external validation.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Short-& Long-term Disability

Accidental Death & Dismemberment

Life Insurance

Employee Assistance Program

401(k) Company Match

Stock Options

Tuition Reimbursement

Paid Vacation

Paid Sick Leave

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

1%
Practical Neurology
Sep 1st, 2026
BIOTECanada names 2026 Gold Leaf Award recipients.

BIOTECanada names 2026 Gold Leaf Award recipients. 09/01/2026 Key takeaways. * BIOTECanada's 2026 Gold Leaf Awards honor organizations and individuals across Canada's biotechnology sector. * BIOTECanada named Xenon Pharmaceuticals as its 2026 Biotech Company of the Year. * Award recipients were selected by an independent committee of leaders from the biotechnology and life sciences ecosystem. BIOTECanada announced the recipients of its 2026 Gold Leaf Awards, naming Xenon Pharmaceuticals (Burnaby, British Columbia, Canada) as Biotech Company of the Year. BIOTECanada describes the Biotech Company of the Year award as recognizing a Canadian company that has distinguished itself through overall performance, leadership, and significant achievement, including milestones related to financing, product development, or partnerships. The recognition follows recent phase 3 activity for Xenon's lead investigational therapy azetukalner, including positive X-TOLE2 data in focal onset seizures and the company's plan to submit a new drug application to the FDA in the third quarter of 2026. The Gold Leaf Awards recognize individuals and organizations across Canada's biotechnology sector. In addition to Xenon, 2026 honorees included Ripple Therapeutics (Toronto, Ontario, Canada) as Promising Biotech Company of the Year, Allen Eaves, MD, PhD, for the Industry Leadership Award, and Massimiliano Paganelli, MD, PhD, and Claudia Raggi, PhD, for the Community Leadership Award in Research and Innovation. Award details. * BIOTECanada stated that the awards recognize leadership, innovation, and impact across Canada's biotechnology sector. * The award recipients were chosen by an independent selection committee. * The honorees will be recognized at the Gold Leaf Awards Ceremony on September 22 at the National Arts Centre in Ottawa, Ontario, Canada. BIOTECanada. BIOTECanada announces 2026 Gold Leaf Award winners, recognizing excellence across Canada's biotechnology ecosystem. Businesswire. Published August 31, 2026. Accessed September 1, 2026. https://www.businesswire.com/news/home/20260831968907/en/BIOTECanada-Announces-2026-Gold-Leaf-Award-Winners-Recognizing-Excellence-Across-Canadas-Biotechnology-Ecosystem

MedCity News
Aug 30th, 2026
SK Bio broadens U.S. Prospects, licensing late-stage epilepsy drug from Biohaven.

SK Bio broadens U.S. Prospects, licensing late-stage epilepsy drug from Biohaven. Biohaven is outlicensing to SK Biopharmaceuticals global rights to opakalim, a Kv7-targeting small molecule in pivotal clinical testing for epilepsy. Biohaven gets non-dilutive financing for its pipeline while SK Bio gains another asset to potentially commercialize in the U.S. By Frank Vinluan on August 30, 2026 10:50 am SK Biopharmaceuticals, a South Korea-based drugmaker that already sells an FDA-approved epilepsy medicine, is expanding its U.S. strategy with a deal for a late-stage molecule from Biohaven that brings a different mechanism of action to the seizure disorder. SK will pay $400 million up front for global rights to the Biohaven drug, opakalim, according to deal terms announced Aug. 26. This Biohaven drug is on track to yield preliminary Phase 2/3 data by the end of this year. A second data readout is expected in 2028. If the drug passes FDA muster, Seoul-based SK said it plans to launch opakalim in the U.S. in 2029. In epilepsy, the abnormal flow of charged ions across cell membranes leads to bursts of electricity in the brain. Opakalim is an activator of Kv7, a protein that forms channels that act like brakes to suppress this abnormal signaling. Biohaven added opakalim to its pipeline via the $100 million purchase of Channel Bio. When that deal was struck in 2022, the molecule, then known as BH7-7000, was approaching Phase 1 testing. The acquisition included the platform technology that produced this epilepsy drug. presented by In an interview, Kyan Health Co-Founder and Chief Commercial Officer Konstantin Struck discussed how Kyan gives mid-market and enterprise employers access to premium workforce mental healthcare, at a price point that is affordable. Biohaven has since advanced opakalim to Phase 3 testing in focal onset epilepsy. The drug faces potential competition in this space. Xenon Pharmaceuticals is in late-stage clinical development with a Kv7-targeting drug, azetukalner. Last year, Jazz Pharmaceuticals licensed rights to Saniona's SAN2355, a preclinical small molecule designed to selectively activate Kv7.2 and Kv7.3, two subtypes of Kv7. SK's upfront payment to Biohaven breaks down to $350 million upon deal closing and $50 million one year after. SK could pay Biohaven up to $395 million more tied to the achievement of milestones, plus royalties from sales of an approved product. A portion of those payments will go to Knopp Biosciences, the company that originally developed opakalim and formed Channel Bio. As of June 30, Biohaven reported its cash position was about $270.5 million. Leerink Partners analyst Marc Goodman said in a research note that outlicensing opakalim makes sense for Biohaven, as this late-stage drug is the company's most valuable asset and the deal with SK brings non-dilutive capital. He added that Biohaven doesn't view itself as a epilepsy company, and it has previously struck business deals involving its neuro assets to raise money for other programs. In 2022, Pfizer acquired Biohaven Pharmaceuticals to get the oral migraine drug Nurtec. The remaining assets were spun out into the current iteration of Biohaven, capitalized by cash from that deal. Goodman said opakalim has a cleaner safer profile versus Xenon's drug, but that raises debate among investors. While some believe cleaner safety indicates the drug is more selective to its target, others say it may be a sign of weaker target engagement. presented by Healthcare payments are no longer about transactions. It's about controlling the revenue cycle. And increasingly, that control is not sitting with ISOs. William Blair analysts said the deal enables Biohaven to focus on key upcoming developments from the rest of its pipeline, including taldefgrobep alfa, a potential new obesity drug. This fusion protein, licensed from Bristol Myers Squibb, is designed to block myostatin and activin signaling to prevent muscle wasting and fat accumulation. Preliminary data from a Phase 2 study are expected by the end of the year. The Biohaven pipeline also includes two late-stage programs: BHV-1300 for Graves' disease BHV-1400 for immunoglobulin A nephropathy. As for SK, the William Blair analysts said licensing deal for opakalim is relatively inexpensive considering that peak sales of novel drugs for the focal segmental epilepsy indication alone are projected to reach $2 billion to $4 billion. But achieving those sales will depend on generating competitive Phase 3 data. The 42.7% placebo-normalized improvement on median monthly seizure frequency shown by Xenon's azetukalner is "a truly remarkable result in a highly refractory population, along with an exceptional ease of use profile," the analysts said. They added that the most likely opportunity for opakalim is to show differentiation on safety, not efficacy. If approved, opakalim will slot into SK Life Science, the South Korean company's New Jersey-based subsidiary that currently markets the anti-seizure medicine cenobamate, brand name Xcopri. Approved by the FDA in 2019, this small molecule drug inhibits sodium currents and modulates GABAA ion channels. In the announcement of the transaction with Biohaven, SK CEO Donghoon Lee said the deal will enable his company to commercialize multiple therapies in the U.S. "This clearly signals that our company has stepped into the major leagues across all dimensions," Lee said.

Yahoo Finance
Aug 6th, 2026
Xenon Pharmaceuticals reports Q2 loss of $110.7M, beats analyst expectations

Xenon Pharmaceuticals reported a second-quarter loss of $110.7 million, or $1.11 per share, beating analyst expectations. The Burnaby, British Columbia-based company performed better than the average estimate of seven analysts surveyed by Zacks Investment Research, who had predicted a loss of $1.16 per share.

Yahoo Finance
May 11th, 2026
Xenon Pharmaceuticals raises $838M, posts positive Phase 3 epilepsy trial data ahead of FDA filing

Xenon Pharmaceuticals has reported positive Phase 3 X-TOLE2 data for azetukalner, its lead epilepsy candidate, and plans to submit a New Drug Application to the FDA in the third quarter of 2026. The company posted a first-quarter 2026 net loss of $102.3 million, or $1.17 per share. The biotech firm raised $837.6 million in equity financing, bringing cash and marketable securities to approximately $1.34 billion. Management expects this will fund operations into 2029, supporting late-stage trials and commercial launch preparations. The strengthened balance sheet reduces financing risk whilst the company remains pre-revenue. Xenon's narrative projects $284.9 million in revenue and $45.7 million in earnings by 2028, requiring 236.2% annual revenue growth. The most optimistic analysts forecast revenue reaching $905 million by 2029.

Yahoo Finance
Mar 28th, 2026
Xenon Pharma chief medical officer sells $78K in shares as stock surges 55%

Xenon Pharmaceuticals chief medical officer Christopher John Kenney sold 1,410 common shares for approximately $78,000 on 13 March 2026, according to an SEC filing. The sale represented 16.63% of his direct holdings. The transaction stemmed from vested restricted share units that delivered 3,750 common shares, with 1,410 immediately sold to cover tax obligations through a routine sell-to-cover instruction. Following the sale, Kenney retains 7,069 directly held shares and 11,250 restricted share units. Xenon Pharmaceuticals develops clinical-stage therapeutics for neurological disorders, with a market capitalisation of $5 billion. The stock has risen 55% over the past year. The company generates revenue primarily through licensing and collaboration agreements, reporting $7.50 million in trailing twelve-month revenue.