临床开发负责人，运动障碍
Clinical Development Leader, Movement Disorders
职位地点：该职位可远程工作，但需要具备灵活并愿意根据需要出差的意愿。
机会简介
优秀的临床开发不仅需要强大的战略，还需要有人愿意承担决策、领导试验、跟随数据，并采取一切必要措施推动有前景的药物为所服务的患者带来希望。在Praxis，你将负责我们运动障碍产品组合的临床领导工作，包括特发性震颤和新适应症。你将制定开发策略，领导研究，解读新兴数据，推动跨职能执行，并将临床策略贯穿于监管提交和与卫生当局的互动中。这是一个需要亲力亲为、希望领导工作的角色，而不仅仅是主要提供咨询或审查。你将具备运动障碍领域的深厚专业知识，并随着我们产品组合的发展，逐步获得更大的责任。
主要职责
- 运动障碍开发：深入理解疾病领域、终点指标、评估工具和患者体验，以支持开发策略和决策。
- 临床策略和试验：将科学、新兴数据、患者需求和监管要求转化为开发策略，并亲自从设计到执行领导研究。
- 数据驱动决策：解读新兴的临床和科学数据，识别关键点，并在信息不完整时做出及时判断。
- 监管策略：负责监管文件中的实质性临床内容，包括简报材料和与卫生当局的互动。
- 跨职能领导：推动临床运营、生物统计、监管、安全等跨部门团队解决问题并推进项目。
- 外部领导：与研究人员、关键意见领袖、卫生当局和合作伙伴可信地代表Praxis。
任职资格和关键成功因素
- 需要拥有高级科学学位（MD、PharmD、PhD或同等学历）。
- 有个人主导的临床试验、项目、提交或重大开发决策的经验。
- 有主导IND、CTA、NDA或MAA文件、简报手册和与卫生当局互动中的临床内容的经验。
- 具备出色的判断力，能够在信息不完整的情况下对新兴数据做出深思熟虑、及时的决策，并知道何时以及如何进行升级。
- 能够在动态环境中自如运作。
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 takes more than a strong strategy. It takes someone willing to own the decisions, lead the trials, follow the data, and do what it takes to move promising medicines forward for the patients we serve. At Praxis, you’ll take clinical leadership across our movement disorders portfolio, including essential tremor and new indications. You’ll shape development strategy, lead studies, interpret emerging data, drive cross-functional execution, and carry clinical strategy through regulatory submissions and health authority interactions. This is a role for someone who is hands-on and wants to lead the work, not just primarily advise or review it. You’ll bring real depth in movement disorders, with the opportunity to take increasing ownership of the area as our portfolio evolves.
Primary Responsibilities
- Movement disorders development: Deep understanding of the disease area, endpoints, rating instruments, and patient experience, to development strategy and decision-making.
- Clinical strategy and trials: Translate science, emerging data, patient need, and regulatory requirements into development strategies—and personally lead studies from design through execution.
- Data-driven decisions: Interpret emerging clinical and scientific data, identify what matters, and make timely calls when information is incomplete.
- Regulatory strategy: Own substantive clinical content for regulatory filings, briefing materials, and health authority interactions.
- Cross-functional leadership: Drive teams across clinical operations, biostatistics, regulatory, safety, and other disciplines to resolve issues and move programs forward.
- External leadership: Represent Praxis credibly with investigators, KOLs, health authorities, and partners.
Qualifications and Key Success Factors
- An advanced scientific degree (MD, PharmD, PhD, or equivalent) is required.
- A track record of clinical trials, programs, submissions, or major development decisions that you personally led.
- Regulatory submissions ownership having carried the clinical content of IND, CTA, NDA, or MAA filings, briefing books, and health authority interactions.
- Strong judgment and the ability to make thoughtful, timely calls on emerging data with incomplete information and the knowledge of what to escalate and when.
- Comfort operating in a dynamic environment within a small, flexible organization where scope shifts and the role is defined by what needs doing rather than by a job description.
- You’ll thrive here if you take ownership, challenge assumptions with scientific rigor, move with urgency without sacrificing quality, and stay focused on outcomes that matter for patients.
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.
Annualized Base Salary
$280,000—$350,000 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.
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