临床开发负责人，生命周期管理
Clinical Development Leader, Lifecycle Management
位置：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
将科学可能性转化为对患者有意义的机会不仅需要专业知识。还需要广度、良好的判断力以及跨项目领导的驱动力，将新兴数据转化为推动药物前进的决策。在Praxis，您将在整个产品管线中提供临床领导力，涵盖生命周期管理活动和早期开发。您将跨机制、适应症和开发阶段工作：塑造机会，领导早期临床工作，解读新兴数据，并将科学和临床洞察转化为开发决策。这是一个以领导工作为主的角色，而不是主要负责建议或审查的人。您需要具备在各个项目间自信移动的广度，以及识别临床开发如何为患者创造最大价值的判断力。
主要职责
- 生命周期策略：识别并推动扩大后期和已上市资产影响的机会，包括新适应症、标签扩展和剂型机会。
- 早期开发：领导首次人体和剂量爬坡研究，应用药代动力学/药效动力学（PK/PD）和新兴临床数据进行剂量选择、决策规则和下一步开发。
- 临床启动：推动IND支持性提交的临床策略和内容，以及将项目推进到人体研究所需的决策。
- 全管线领导力：在机制、适应症和阶段之间可信地工作，快速建立所需背景以做出良好的临床开发决策。
- 数据驱动决策：解读新兴的临床和科学数据，识别关键点，并在信息不完整时及时做出决定。
- 跨职能和外部领导力：推动临床运营、生物统计、监管、安全、转化科学等其他学科的团队工作，同时在与研究者、关键意见领袖（KOL）、监管机构和合作伙伴的交流中代表Praxis保持可信度。
资格和关键成功因素
- 需要拥有高级科学学位（医学博士MD、药学博士PharmD、哲学博士PhD或同等学历）。
- 有亲自领导临床试验、项目、提交或重大开发决策的经验。
- 有主导IND、CTA、NDA或MAA文件的临床内容、简报手册和监管机构提交的监管提交经验。
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
Turning scientific possibilities into meaningful opportunities for patients takes more than expertise. It takes breadth, sound judgment, and the drive to lead across programs, translating emerging data into decisions that move medicines forward. At Praxis, you’ll provide clinical leadership across lifecycle management activities and early-phase development throughout our pipeline. You’ll work across mechanisms, indications, and stages of development: shaping opportunities, leading early clinical work, interpreting emerging data, and turning scientific and clinical insights into development decisions. This is a role for someone who leads the work, not someone who primarily advises or reviews it. You’ll bring the breadth to move confidently across programs and the judgment to identify where clinical development can create the greatest value for patients.
Primary Responsibilities
- Lifecycle strategy: Identify and drive opportunities to expand the impact of late-stage and marketed assets, including new indications, label expansion, and formulation opportunities.
- Early development: Lead first-in-human and dose-escalation studies, applying PK/PD and emerging clinical data to dose selection, decision rules, and next-stage development.
- Clinical entry: Drive the clinical strategy and content for IND-enabling submissions and the decisions required to move programs into human studies.
- Pipeline-wide leadership: Work credibly across mechanisms, indications, and phases, quickly developing the context needed to make sound clinical development decisions.
- Data-driven decisions: Interpret emerging clinical and scientific data, identify what matters, and make timely calls when information is incomplete.
- Cross-functional and external leadership: Drive teams across clinical operations, biostatistics, regulatory, safety, translational sciences, and other disciplines, while representing 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.
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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