Careers · Founding team加入我们 · 创始团队

We are looking for exceptional people to join us.

我们正在寻找卓越的人才,与我们同行。

We are building an exceptional team to carry serious science from research grade to an approved clinical product. If one of the roles below fits you, we would like to hear from you.

我们正在组建一支卓越的团队,推动严谨的科学成果从实验室走向获批上市的临床产品。如果以下职位与你契合,期待收到你的来信。

About Linnaea Bio

关于林奈生物

Linnaea Bio finds scientific work of the highest order that has waited, unnoticed, in the world's most serious laboratories — and carries it, with care, to the physicians and patients it was meant for.

Our lead program is a blood-based companion diagnostic for benign prostatic hyperplasia. The standard first-line drug class has been used for more than thirty years, yet works for only about one in three patients, and no test today can tell in advance who will respond. We are building that test — and the small, senior team that will take it through registration to the clinic.

林奈生物致力于从全球顶尖实验室中,发掘那些水平卓越却尚未得到充分重视的科学成果,并将其稳步转化,带到真正需要它的医生和患者身边。

我们的首个项目是良性前列腺增生的血液伴随诊断。一线标准药物已使用三十多年,却只对约三分之一的患者有效,而目前还没有任何检测能在用药前预判疗效。我们正在开发这项检测,并组建一支精干、资深的团队,推动它完成注册、走向临床。

Open role

Chief Technology Officer (CTO)

Full-time · Executive

招聘职位

首席技术官(CTO)

全职 · 高管

The role

You will be our first technology leader. You own the path that turns a research-grade assay into a manufacturable, validated IVD product ready for registration and launch — and you make the decisions that define the product for the next decade.

What you will own

  • Technology transfer — take the research protocol to its productized form: platform choice (qPCR / ddPCR / targeted methylation sequencing), reagent design, cutoff definition, reference materials.
  • CDMO / CRO strategy — select, contract and manage development and manufacturing partners; own the technical statement of work, milestone acceptance and quality gates.
  • Analytical validation — design and run analytical performance studies (LoD, precision, reproducibility, interference, specimen stability) to support regulatory filings.
  • Platform and IP — build the freedom-to-operate map and the defensive patent position around assay chemistry and workflow, with leadership and counsel.
  • Bridge — translate between our scientific founders, the regulatory and clinical team, and external partners.
  • Team — build and lead a technology-transfer team as milestones unlock.

What you bring

  • 10+ years in molecular diagnostics product development, with hands-on ownership of at least one IVD product from prototype to regulatory submission.
  • Deep expertise in DNA methylation chemistry (bisulfite or enzymatic conversion, MSP/MethyLight) and/or qPCR, ddPCR or targeted NGS assay design.
  • A track record managing CDMO/CRO partners — from the sponsor side or from senior roles inside an IVD CDMO.
  • Working knowledge of IVD registration pathways and ISO 13485 design controls.
  • Fluent professional English and Mandarin.
  • You are comfortable building from zero: high autonomy, few resources, direct impact.

Nice to have

  • PhD in molecular biology, biochemistry, bioengineering or a related field.
  • Companion diagnostic (drug–diagnostic co-development) experience.
  • Experience with LDT launches in China's pilot programs.
  • Founding-team experience at a diagnostics start-up.

How to apply

Email your CV and a one-page note to contact@linnaeabio.com with the subject "CTO — [Your Name]".

职位概述

作为公司首位技术负责人,你将主导把一项研究阶段的检测方法,发展为可稳定生产、经过充分验证、具备注册与上市条件的 IVD 产品。你的关键决策,将决定这款产品未来十年的走向。

主要职责

  • 技术转移——将研究方案转化为成熟产品,包括检测平台选择(qPCR / ddPCR / 靶向甲基化测序)、试剂设计、判读阈值(cutoff)设定及参考品建立。
  • CDMO / CRO 管理——遴选并管理研发与生产合作方,负责技术方案、里程碑验收和质量把控。
  • 分析性能验证——设计并完成检出限、精密度、重复性、干扰、样本稳定性等分析性能研究,为注册申报提供支持。
  • 平台与知识产权——与管理层及法律顾问合作,围绕检测化学与工作流程开展自由实施(FTO)分析,建立防御性专利布局。
  • 跨团队协同——衔接科学创始人、法规与临床团队以及外部合作方,确保技术沟通顺畅高效。
  • 团队建设——随项目推进,组建并带领技术转移团队。

任职要求

  • 10 年以上分子诊断产品开发经验,亲自主导过至少一款 IVD 产品从原型到注册申报的全过程。
  • 精通 DNA 甲基化检测技术(亚硫酸氢盐或酶法转化、MSP/MethyLight),和/或 qPCR、ddPCR、靶向 NGS 检测设计。
  • 具备管理 CDMO/CRO 合作方的实际经验,申办方或 IVD CDMO 高级岗位背景均可。
  • 熟悉体外诊断产品注册路径及 ISO 13485 设计控制要求。
  • 中英文均可作为工作语言。
  • 适应从零起步的创业环境,能够独立推动工作,在有限资源下取得实质成果。

优先条件

  • 分子生物学、生物化学、生物工程或相关专业博士学位。
  • 伴随诊断(药物与诊断联合开发)经验。
  • 参与过国内 LDT 试点项目落地。
  • 诊断领域初创企业创始团队经历。

如何申请

请将简历及一页自荐信发送至 contact@linnaeabio.com,邮件标题请注明 "CTO — [姓名]"。

Apply by email邮件申请

Open role

Chief Medical Officer (CMO)

Full-time · Executive

招聘职位

首席医学官(CMO)

全职 · 高管

The role

You will be our senior physician-scientist. You own the medical case for the product: the clinical evidence that proves it changes treatment decisions, the studies that generate that evidence, and the urology community that will adopt it. You work hand in hand with our VP of Regulatory Affairs, who owns the filings your evidence supports.

What you will own

  • Clinical development strategy — define intended use, target population and the clinical claims the product will carry.
  • Clinical performance and utility studies — design protocols, choose endpoints, select sites and principal investigators, and oversee execution with CRO partners through readout.
  • Medical leadership in regulatory interactions — own the clinical sections of submissions and represent the medical position in meetings with regulators.
  • KOL and scientific community — build relationships with leading urologists; lead the scientific advisory board with our founders; drive publications, congress presence and expert consensus.
  • Guideline and pathway strategy — plan the evidence needed for inclusion in Chinese and international BPH guidelines and clinical pathways.
  • Medical governance — clinical safety, ethics, medical review of external materials, and post-market evidence.

What you bring

  • MD (or equivalent clinical degree) with clinical training; urology, oncology or laboratory medicine strongly preferred.
  • 10+ years in clinical development or medical affairs in diagnostics, precision medicine or pharma, including leading at least one clinical study that supported a regulatory approval.
  • Strong grasp of diagnostic study design: sensitivity/specificity, predictive value, clinical utility, and drug–diagnostic co-development.
  • An established network among Chinese urology or oncology KOLs and experience working with tertiary-hospital GCP sites.
  • Fluent professional English and Mandarin; able to present to regulators, physicians and investors.
  • You are comfortable building from zero: high autonomy, few resources, direct impact.

Nice to have

  • Companion diagnostic experience.
  • International training or clinical research experience.
  • Experience with real-world evidence and pilot LDT programs in China.
  • Founding-team or start-up experience.

How to apply

Email your CV and a one-page note to contact@linnaeabio.com with the subject "CMO — [Your Name]".

职位概述

作为公司资深医生科学家,你将负责产品的医学价值论证:以临床证据证明它能够改变治疗决策,设计并推动产生这些证据的临床研究,并赢得泌尿外科学界的认可与采用。你将与法规事务副总裁紧密配合,为注册申报提供临床证据支持。

主要职责

  • 临床开发策略——明确产品的预期用途、目标人群及临床声明。
  • 临床性能与临床效用研究——设计研究方案、确定终点指标、遴选研究中心与主要研究者,并与 CRO 合作推进研究,直至获得研究结果。
  • 监管沟通中的医学职责——负责申报资料中的临床部分,并在与监管机构的沟通中阐述公司的医学观点。
  • KOL 与学术合作——与泌尿外科领域的权威专家建立合作;与创始人共同领导科学顾问委员会;推动论文发表、学术会议交流及专家共识。
  • 指南与临床路径——规划产品纳入国内外 BPH 诊疗指南及临床路径所需的证据。
  • 医学合规管理——负责临床安全、伦理审查、对外材料的医学审核及上市后证据收集。

任职要求

  • 医学学位,接受过系统的临床培训;泌尿外科、肿瘤科或检验医学背景优先。
  • 10 年以上诊断、精准医学或制药领域的临床开发或医学事务经验,并主导过至少一项支持产品获批的临床研究。
  • 深入理解诊断类研究设计,包括灵敏度与特异度、预测值、临床效用,以及药物与诊断联合开发。
  • 在国内泌尿外科或肿瘤领域拥有广泛的专家网络,并有与三甲医院 GCP 机构合作的经验。
  • 中英文均可作为工作语言,能够面向监管机构、医生及投资人进行专业陈述。
  • 适应从零起步的创业环境,能够独立推动工作,在有限资源下取得实质成果。

优先条件

  • 伴随诊断经验。
  • 海外培训或临床研究经历。
  • 真实世界研究及国内 LDT 试点项目经验。
  • 创始团队或初创企业经历。

如何申请

请将简历及一页自荐信发送至 contact@linnaeabio.com,邮件标题请注明 "CMO — [姓名]"。

Apply by email邮件申请

Open role

Vice President, Regulatory Affairs

Full-time · Executive

招聘职位

法规事务副总裁

全职 · 高管

The role

You will be our first regulatory leader, partnering closely with the CMO and CTO. You own the path from today to approval: a dual-track strategy of an early laboratory-developed test (LDT) launch through China's pilot programs, and formal product registration as the anchor — with a roadmap to approvals in further markets.

What you will own

  • Registration strategy and submission — classification, technical requirements, pre-submission communication with regulators, submission, review responses and approval.
  • LDT track — choose the pilot region, set up the laboratory's regulatory basis, and manage filings with provincial health authorities.
  • Quality system — establish the ISO 13485 quality management system with our QA lead, plus ISO 15189 / CAP readiness for the laboratory.
  • Human Genetic Resources — own HGR applications for every study using Chinese biospecimens.
  • Global roadmap — plan regulatory pathways in international markets, including bridging strategy.
  • Regulatory intelligence — track policy on companion diagnostics, LDTs and IVD classification, and turn it into decisions.

What you bring

  • 10+ years in IVD regulatory affairs, with hands-on ownership of at least one high-risk IVD registration (companion diagnostic or molecular IVD preferred).
  • Direct experience in pre-submission communication with regulators and in answering review questions.
  • Working knowledge of IVD clinical evaluation guidance, human genetic resources rules, and ISO 13485.
  • Fluent professional English and Mandarin.
  • You are comfortable building from zero: high autonomy, few resources, direct impact.

Nice to have

  • International regulatory submission experience.
  • Experience with LDT pilot programs.
  • Experience building a QMS or leading ISO 15189 / CAP accreditation.
  • Founding-team or start-up experience.

How to apply

Email your CV and a one-page note to contact@linnaeabio.com with the subject "VP Regulatory — [Your Name]".

职位概述

作为公司首位法规负责人,你将与 CMO、CTO 紧密协作,全面负责产品从当前阶段到获批上市的注册路径。我们采取双轨策略:一方面借助国内试点政策,率先以实验室自建检测(LDT)形式开展临床应用;另一方面以正式产品注册为核心目标,并规划进入更多市场的路线图。

主要职责

  • 注册策略与申报——负责产品分类界定、技术要求制定、申报前与监管机构的沟通、正式申报及发补答复,直至产品获批。
  • LDT 路径——选择试点地区,建立实验室的合规基础,并负责向省级卫生健康主管部门的备案工作。
  • 质量体系——与质量负责人共同建立 ISO 13485 质量管理体系,并推动实验室达到 ISO 15189 / CAP 认可要求。
  • 人类遗传资源——负责所有涉及中国人类遗传资源样本研究的相关申报。
  • 国际注册规划——规划国际市场的注册路径,包括桥接策略。
  • 法规研究——持续跟踪伴随诊断、LDT 及 IVD 分类相关政策,为公司决策提供依据。

任职要求

  • 10 年以上 IVD 法规事务经验,亲自主导过至少一款高风险类别 IVD 产品注册,伴随诊断或分子诊断产品优先。
  • 具备申报前与监管机构沟通、答复审评意见的实际经验。
  • 熟悉体外诊断试剂临床评价相关指导原则、人类遗传资源管理规定及 ISO 13485。
  • 中英文均可作为工作语言。
  • 适应从零起步的创业环境,能够独立推动工作,在有限资源下取得实质成果。

优先条件

  • 国际市场注册申报经验。
  • LDT 试点项目经验。
  • 建立质量管理体系或主导 ISO 15189 / CAP 认可的经验。
  • 创始团队或初创企业经历。

如何申请

请将简历及一页自荐信发送至 contact@linnaeabio.com,邮件标题请注明 "VP Regulatory — [姓名]"。

Apply by email邮件申请