Clinical Development Leader, Epilepsies
位置：这个职位可以从远程执行，但需要灵活性和愿意根据需要旅行。将有前途的科学转化为更好的疾治疗不仅需要专业知识。它需要拥有能力，健全判断力以及领导试验并将新兴数据转化成决定，使我们服务的患者获得药物进展。在 Praxis,你将采取临床领导作用，跨越成人计划和儿科研究。你将通过监管提交和卫生当局互动来塑造发展战略，领导研究，解释新兴数据，推动跨功能执行以及实施临床策略。这是一个实践者并希望领导工作的人员的角色，而不仅仅是对他人的工作进行审查和咨询。你带来了深刻的性发育经验，同时也帮助建立其他临床领导者的能力。主要责任 · ?? 性发育：应用对成年和儿童病，试验设计，终点以及监管途径的深入了解。包括 PIP 和 PSP 等儿科要求在内的，应用于发展战略和决策。·临床战略和试验：将科学，新兴数据，患者需求和监管要求转化为开发战略。·从设计到执行进行个人研究。·基于数据的决定：解释新出现的临床和科学数据，确定重要的事情，并及时调用信息不完整时。·监管战略：针对监管文件，简报材料和卫生当局互动的实质性临床内容。· 跨职能领导：推动团队在临床运营，生物统计学，监管，安全和其他学科中解决问题并推进项目。· 团队发展：将你的计划和提交经验带来强化其他临床领导者，扩大他们的判断力，拥有能力和领导越来越复杂的开发工作的能力。· 外层领导：与调查人员，KOL,卫生当局和合作伙伴一起可信地代表实践。资格和关键成功因素 ·需要先进科学学位 （MD, PharmD,博士或相等）. · 你亲自领导的临床试验，计划，提交或重大发展决定记录。· 监管提交权承载了临床内容。
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Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
Turning promising science into better treatments for epilepsy takes more than expertise. It takes ownership, sound judgment, and the drive to lead trials and translate emerging data into decisions that move medicines forward for the patients we serve.At Praxis, you’ll take clinical leadership across our epilepsy portfolio, spanning adult programs and pediatric studies. 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 review and advise on the work of others. You bring deep epilepsy development experience while also helping build the capabilities of other clinical leaders across the portfolio.
Primary Responsibilities
- Epilepsy development: Apply deep understanding of adult and pediatric epilepsy, trial design, endpoints, and the regulatory pathway – including pediatric requirements such as PIP and PSP – 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.
- Team development: Bring your program and submission experience to strengthen other clinical leaders, expanding their judgment, ownership, and ability to lead increasingly complex development work.
- 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 submission 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 where priorities shift, scope evolves, and ownership matters more than rigid role boundaries.
- 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.
- Thrives in a dynamic environment where priorities shift, scope evolves, and ownership matters more than rigid role boundaries.
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
$280,000—$350,000 USD
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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Originally posted on Himalayas