出海雷达

临床医学监查员

Clinical Medical Monitor

其他限定地区(需当地身份)
公司Praxis Precision Medicines
薪资未公开
工作地点United States - Remote
地域资格限定地区(需当地身份)
时区要求无特别要求
用工类型未标注
发布时间2026-09-01
数据来源Greenhouse
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注意地域限制:该职位明确限定在 United States - Remote 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

位置:此职位可以远程工作,但需要具备灵活的适应能力和愿意根据需要出差。

机会

优秀的临床开发依赖于关键时刻的医学判断:当研究者有疑问、安全事件需要评估或新兴数据需要采取行动时。在Praxis,您将为指定的临床项目提供直接的医学监督,以患者安全和研究质量为核心。您将支持研究者和研究中心在入组标准、给药、安全事件和其他医学问题方面;审查临床和安全数据;评估严重不良事件;并识别新兴信号或趋势。您将与临床负责人和跨职能研究团队紧密合作,同时保持独立的医学判断。这是一个希望贴近患者、研究中心和数据,并做出及时、周到决策,确保研究安全有效地进行的角色。

主要职责

  • 医学监督:为指定的研究提供及时的医学指导,包括入组标准、给药、方案要求、安全事件和其他与研究相关的医学问题。
  • 临床安全评估:审查不良事件(AE)和严重不良事件(SAE),评估因果关系、严重程度、预期性、临床意义以及对患者和项目的潜在影响。
  • 研究中心支持:及时且一致地回应研究者和研究中心的医学问题,平衡患者安全、方案要求和合理的临床判断。
  • 数据监测:审查患者级别的和汇总的临床和安全数据,以识别趋势、不一致之处、新兴信号和需要后续跟进的领域。
  • 安全与法规合规:确保医学监测、安全评估、升级和文档符合适用的法规要求、GCP标准和研究方案。
  • 跨职能合作:与临床开发、临床运营、安全/药物警戒、生物统计、数据管理及监管同事密切合作,解决相关问题并支持高质量的研究执行。
  • 独立判断:在决策中提供清晰的医学视角,必要时挑战假设,并知道何时以及如何进行升级。

资格和关键成功因素

  • 需要医学博士(MD)或同等医学学位;具有神经科学(CNS)或相关治疗领域经验者优先。
  • 具有负责医学监测的临床试验经验。
查看英文原文

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Great clinical development depends on strong medical judgment in the moments that matter: when an investigator has a question, a safety event needs assessment, or emerging data require action. At Praxis, you’ll provide hands-on medical oversight for assigned clinical programs, with patient safety and study quality at the center. You’ll support investigators and sites on eligibility, dosing, safety events, and other medical questions; review clinical and safety data; assess serious adverse events; and identify emerging signals or trends. You’ll partner closely with clinical leads and cross-functional study teams while maintaining independent medical judgment. This is a role for someone who wants to stay close to the patients, sites, and data and make timely, thoughtful decisions that keep studies moving safely and effectively.

Primary Responsibilities

  • Medical oversight: Provide timely medical guidance for assigned studies, including eligibility, dosing, protocol requirements, safety events, and other study-related medical questions.
  • Clinical safety assessment: Review AEs and SAEs, assessing causality, severity, expectedness, clinical significance, and potential implications for patients and the program.
  • Site support: Respond promptly and consistently to investigator and site medical questions, balancing patient safety, protocol requirements, and sound clinical judgment.
  • Data surveillance: Review patient-level and aggregate clinical and safety data to identify trends, inconsistencies, emerging signals, and areas requiring follow-up.
  • Safety and regulatory compliance: Ensure medical monitoring, safety assessment, escalation, and documentation meet applicable regulatory requirements, GCP standards, and study protocols.
  • Cross-functional partnership: Work closely with clinical development, clinical operations, safety/pharmacovigilance, biostatistics, data management, and regulatory colleagues to resolve issues and support high-quality study execution.
  • Independent judgment: Bring a clear medical perspective to decisions, challenge assumptions when warranted, and know what to escalate and when.

Qualifications and Key Success Factors

  • MD or equivalent medical degree required; CNS or relevant therapeutic area experience preferred.
  • Clinical trial experience with responsibility for medical monitoring, clinical safety, or related medical oversight. The position may be hired at the Director or Senior Director level based on the depth and breadth of relevant experience.
  • Strong clinical judgment and demonstrated ability to assess AEs and SAEs consistently and rigorously.
  • Experience responding to investigator and site medical questions and making timely decisions when information is incomplete.
  • Ability to review clinical data, recognize meaningful patterns or potential safety signals, and determine when action or additional surveillance is needed.
  • Working knowledge of GCP, clinical trial safety reporting requirements, and documentation standards.
  • You’ll thrive here if you stay close to the work, communicate clearly, exercise independent judgment, and take ownership. You know when speed matters, when deeper investigation is needed, and when to escalate, all while keeping patient safety at the center.

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary in the range listed below.  This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.
Annualized Base Salary
$260,000—$335,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together!

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.  At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.  Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

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