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BeOne

Global oncology therapeutics discovery, development, manufacturing

Regional Clinical Compliance Optimization Lead

Full-TimeUpdated on 10/23/2026
CHF156.2k - CHF195.2k
Expert
Bachelor's
Basel, Switzerland
In PersonUp to 10% travel.
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical, or healthcare discipline.
  • 10+ years in clinical research or clinical operations, plus a minimum of 4 years of experience in a GCP compliance or equivalent quality role; exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.
  • Experience with Risk-Based Quality Management principles, risk identification, and data-driven decision-making.
  • Experience in process improvement, operational excellence, or quality initiatives.
  • Experience supporting or implementing global process changes.
  • PC literacy and Microsoft Office skills, including Outlook, Word, Excel, and PowerPoint.
Responsibilities
  • Identify and analyze signals, trends, and systemic issues across EMEA using compliance-generated data, audit findings, inspection outcomes, and operational insights.
  • Translate aggregated insights into meaningful risk patterns and improvement opportunities.
  • Provide regular reporting and recommendations to stakeholders to support informed decision-making.
  • Propose and support process improvements based on identified trends and systemic issues.
  • Collaborate with Risk-Based Quality Management teams to integrate findings into process risk assessment and risk mitigation strategies.
  • Ensure improvements align with Good Clinical Practice requirements, company procedures, and quality standards.
  • Identify areas for additional training and support the preparation and delivery of educational sessions within EMEA.
  • Support regional and country-level process improvement initiatives to enhance efficiency, compliance, and consistency.
  • Act as a liaison between regional and country teams and Global Clinical Compliance and global process owners.
  • Facilitate regional implementation of improvements identified at global, local, or regional levels, ensuring scalability and sustainability.
  • Promote best-practice sharing across countries and regions.
  • Partner cross-functionally with Clinical Operations, Quality Assurance, Risk-Based Quality Management, and Global Compliance teams.
  • Influence stakeholders at multiple levels to drive adoption of process enhancements.
  • Support change-management activities related to new or updated processes.
Desired Qualifications
  • At least 4 years of experience in a GCP compliance or equivalent quality role is preferred.
  • Experience in data analytics, metrics, and key performance indicator management is preferred.
  • Certification in quality management, clinical research, or process improvement methodologies, such as Lean Six Sigma, is a plus.
  • Experience in oncology global trials is preferred.

About the company

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BeOne

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Website

BeOne Medicines develops and commercializes cancer therapies for patients worldwide, focusing on hematologic cancers and solid tumors. Its products, including Brukinsa, are sold globally and supported by licensing partnerships, with internal R&D and clinical development driving a broad late-stage pipeline. BeOne differentiates itself by leveraging a large-scale clinical trial network and cost-efficient global drug development to achieve high margins while pursuing large-market indications. The company aims to expand into immunology and solid tumors while maintaining strong investment in R&D to make high-impact, accessible oncology treatments available in more than 45 countries.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Dongcheng District, China

Founded

2010

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Simplify's Take

What believers are saying

  • August 25, 2026 FDA approval expanded TEVIMBRA in first-line HER2-positive gastroesophageal cancer.
  • August 31, 2026 Phase 3 survival data strengthened ZIIHERA-containing regimens.
  • Q2 2026 revenue hit $1.7 billion; management raised 2026 guidance to $6.8 billion.

What critics are saying

  • BeOne accepted developed-market pricing parity and Medicaid rebates on future U.S. approvals.
  • Zydus' BRUKINSA ANDA lawsuit targets patents; a 2034 composition patent remains the fortress.
  • AbbVie's trade-secrets case over BGB-16673 still threatens the BTK-degrader franchise.

What makes BeOne unique

  • BeOne built 35-plus assets and 93 trials across 1,100 U.S. sites by September 2026.
  • BRUKINSA dominates revenue, with 2026 global sales above $1.2 billion quarterly.
  • Hopewell, New Jersey gives BeOne U.S. manufacturing, R&D, and packaging capacity.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • 401(k) Retirement Plan
  • Wellness Program
  • Paid Vacation

Growth & Insights and Company News

6 month growth

8%

1 year growth

-6%

2 year growth

-1%
Associated Press
Oct 6th, 2026
Onco360 partners with BeOne Medicines to distribute Beqalzi for relapsed mantle cell lymphoma

Onco360, an independent specialty pharmacy, has been selected as a pharmacy partner by BeOne Medicines for Beqalzi (sonrotoclax). The drug is indicated for treating adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor. Beqalzi is a BCL-2 protein inhibitor. In a Phase 1/2 study of 103 adult patients with relapsed/refractory mantle cell lymphoma, the drug achieved an overall response rate of 52.4%, with a median time to response of 1.9 months. The median duration of response was 15.8 months. Onco360 is headquartered in Louisville, Kentucky, and operates as a flagship brand of PharMerica Corporation.

Yahoo Finance
Sep 4th, 2026
BeOne secures US pharma-tariff exemption after $1B+ manufacturing investment, but pricing concessions raise margin concerns

BeOne Medicines secured an exemption from Section 232 pharmaceutical tariffs through a voluntary agreement with the US government. The deal recognises over $1 billion in US manufacturing investment, including a $300 million expansion in Hopewell, New Jersey. The exemption protects BeOne from import duties on patented pharmaceuticals and ingredients. However, the company committed to pricing future FDA-approved medicines in line with other developed markets and participating in the Medicaid GENEROUS Model, which uses supplemental rebates. The Hopewell expansion will add small-molecule manufacturing and packaging capacity, creating approximately 120 full-time jobs. The facility will support a portfolio of more than 35 assets. Whilst the tariff exemption reduces supply-chain risk, international reference pricing commitments could limit pricing flexibility for future oncology medicines. Neither the tariff savings nor the financial impact of pricing concessions was disclosed.

Yahoo Finance
Aug 13th, 2026
Revolution Medicines shares rise 6.2% on BeOne-funded Phase 3 RAS(ON) deal

Revolution Medicines has partnered with BeOne Medicines in a multi-part collaboration combining BeOne's oncology assets with Revolution's four clinical RAS(ON) inhibitors. The August 2026 deal grants BeOne exclusive development and commercialisation rights in select Asian markets and commits BeOne to fund a global Phase 3 trial. Revolution Medicines reported a net loss of $644.37 million in Q2 2026 and $1.1 billion over six months. The company currently generates no revenue but projects $2.3 billion in revenue and $402.5 million in earnings by 2029. The partnership shifts near-term risk by offloading Phase 3 costs whilst providing access to milestone and royalty potential. However, the core investment case remains unchanged: regulatory progress and commercialisation of daraxonrasib, with trial execution and spending presenting the biggest risks.

Yahoo Finance
Aug 5th, 2026
BeOne Medicines Q2 revenue up 30% to $1.7B as BRUKINSA sales top $1.2B globally

BeOne Medicines reported second-quarter revenue of $1.7 billion, up 30% year over year, with GAAP earnings per ADS rising 144% to $2.05. The company's BTK inhibitor BRUKINSA generated more than $1.2 billion in global sales, increasing 31% from the prior year. The company raised its 2026 revenue guidance to CNY 6.6 billion–CNY 6.8 billion and expects GAAP operating income of CNY 1 billion–CNY 1.1 billion. Free cash flow doubled year over year to CNY 435 million. BeOne received FDA approval for Beqalzi in relapsed or refractory mantle cell lymphoma and reported positive Phase III results for a chemotherapy-free BRUKINSA regimen. US BRUKINSA sales totalled $893 million, up 31%, driven by demand in chronic lymphocytic leukaemia and non-CLL indications.

Yahoo Finance
Jul 23rd, 2026
BeOne CEO sells $34.6M in stock while retaining 50M+ shares

John Oyler, chief executive officer of BeOne Medicines AG, sold 109,713 American Depositary Shares worth $34.6 million on 20 and 21 July 2026, according to SEC filings. The transactions were executed under a Rule 10b5-1 trading plan adopted in March 2026. Despite the sale, Oyler retains a substantial ownership position exceeding 50.4 million total shares through various holdings. These include 28.2 million shares held through Oyler Investment LLC and 9.5 million shares in a Roth IRA account. The shares were sold at a weighted average price of $315.28. BeOne Medicines is a commercial-stage oncology biopharmaceutical company with $5.7 billion in trailing twelve-month revenue and a market capitalisation of $34.2 billion.