Clinical Development Leader, Movement Disorders
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。机会大临床发展不仅需强大的战略。需要一个愿意掌握决策的人,领导试验,跟踪数据,并做必要的一切事情来为我们服务的患者推进有前途的药物。在 Praxis,你将采取我们的运动障碍组合中临床领导力,包括基本震动和新迹象。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,并运行临床策略。这是一个实践者希望领导工作的人员的角色,而不仅仅是首要建议或审查它。你将为运动障碍带来真正深入了解,随着我们的投资组合不断演变,有机会对该领域拥有越来越多的主权。主要责任 ·运动障碍开发:对疾病区域,终点,评级仪器和患者经验的深刻理解,到发展策略和决策方面:·临床策划和试验:转化科学,新兴数据,患者需求和监管要求成为开发战略并从设计到执行进行个人领导研究。· 数据驱动的决策:解释新兴临床和科学数据,确定重要内容,并在信息不完整时及时拨打电话。·监管战略:为监管文件,简报材料和卫生当局互动提供实质性的临床内容。·跨功能领导:推动团队跨越临床运营,生物统计学,监管,安全和其他学科解决问题并推进计划。·外部领导力:代表 Praxis 与调查人员,KOLs,卫生当局和合作伙伴进行可信的表现。资格和关键成功因素 ·需要先进科学学位 (MD, PharmD,博士或相等). ·你个人领导的临床试验,计划,提交或重大发展决策记录。·监管提交权持有 IND,CTA,NDA 或 MAA 文件,简报书籍以及卫生机构互动的临床内容。·强大的判断力和对新兴数据提出不完整信息及知识及时调用的能力。·在充满活力的环境中运营舒适性。
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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.
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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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.
Originally posted on Himalayas