科学叙事负责人
Scientific Narrative Lead
Location: 该职位可以远程工作,但需要具备灵活安排并愿意根据需要出差
职位机会
Praxis Precision Medicines 是一家完全整合的、处于临床阶段的精准神经科学公司,利用基因洞察力发现和开发针对罕见和更常见神经系统疾病的疗法。随着我们产品组合向监管申报和商业发布推进,科学叙事负责人将负责 Praxis 一个主要开发项目的战略科学故事——确保其科学性、数据、差异化和对患者的价值在临床开发、监管提交、上市和生命周期管理过程中得到清晰且一致的理解。
这是一个项目领导角色,而不仅仅是写作角色。您将深入了解该项目——其机制、证据、开发策略、竞争环境和不断变化的数据,并利用这种理解来定义其科学故事随时间发展的方向。您将跨职能地连接想法和证据,使监管提交、临床出版物以及医学事务和商业沟通强化一个科学严谨且具有差异化的统一故事。
成功需要对科学保持好奇心,判断哪些内容重要,并具备影响不同视角的人的能力。您将与监管策略、临床开发、非临床、医学事务、商业和其他合作伙伴密切合作,在需要时挑战假设,并在数据或前进路径复杂时创造清晰度。
主要职责
- 负责一个主要 Praxis 项目的战略科学叙事,深入掌握其科学、数据、开发策略、竞争背景和潜在患者价值,并将这些知识转化为清晰、有差异的信息框架。
- 建立并维护一个面向未来的叙事和传播路线图,将项目策略、新出现的证据、关键里程碑、监管互动、出版物和上市准备联系起来,而不是将每个交付物视为独立事件。
- 在关键的临床和监管文件中塑造科学定位和核心信息,包括方案、研究者手册、临床研究报告、简报文件、临床概述和综合摘要;直接
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
Praxis Precision Medicines is a fully integrated, clinical-stage precision neuroscience company that applies genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders. As we advance our portfolio toward regulatory filings and commercial launch, the Scientific Narrative Lead will own the strategic scientific story for one of Praxis’s lead development programs—ensuring that its science, data, differentiation, and potential value to patients are understood clearly and consistently from clinical development through regulatory submission, launch, and lifecycle management.
This is a program leadership role, not simply a writing role. You will become deeply fluent in the program—its mechanism, evidence, development strategy, competitive landscape, and evolving data—and use that understanding to define how its scientific story should develop over time. You will connect ideas and evidence across functions so that regulatory submissions, clinical publications, and Medical Affairs and Commercial communications reinforce one scientifically rigorous and differentiated story.
Success requires curiosity to get deep into the science, judgment to determine what matters, and the influence to align people who may see the program through very different lenses. You will work closely with Regulatory Strategy, Clinical Development, Nonclinical, Medical Affairs, Commercial, and other partners, challenging assumptions when needed and creating clarity when the data or path forward is complex.
Primary Responsibilities
- Own the strategic scientific narrative for a lead Praxis program, building deep fluency in its science, data, development strategy, competitive context, and potential value to patients and translating that knowledge into a clear, differentiated messaging framework.
- Build and maintain a forward-looking narrative and communications roadmap that connects program strategy, emerging evidence, key milestones, regulatory interactions, publications, and launch preparation rather than treating each deliverable as a standalone event.
- Shape the scientific positioning and key messages within critical clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, briefing documents, clinical overviews, and integrated summaries; directly author or lead authoring of high-impact documents when needed.
- Set narrative direction for US and global regulatory submissions, including INDs, NDAs, and MAAs, partnering closely with Regulatory Affairs, regulatory writing, Clinical Development, and program teams to ensure the evidence tells a clear, rigorous, and consistent story.
- Anticipate how new data, regulatory feedback, competitive developments, and program decisions should change—or reinforce—the scientific story, and advise program and company leadership on the implications.
- Serve as a connective thread across Clinical Development, Clinical Pharmacology, Nonclinical, Regulatory Affairs, Biostatistics, Data Management, Quality, CMC, Medical Affairs, and Commercial, identifying inconsistencies early and driving alignment around the evidence and its interpretation.
- Carry the scientific narrative forward as the program matures, including through launch, label expansion, new indications, and post-approval commitments, while contributing to stronger scientific narrative practices and standards across Praxis.
Qualifications and Key Success Factors
- Bachelor’s degree in a scientific discipline required; an advanced scientific or clinical degree is preferred, and experience in CNS, neuroscience, or rare disease is a plus.
- 6+ years of experience in a biopharmaceutical sponsor, CRO, or consulting environment spanning scientific or strategic communications, regulatory strategy, medical affairs, or related drug development work.
- Demonstrated ability to get deeply into complex scientific and clinical data, determine what matters, and synthesize it into a clear, compelling, and scientifically defensible story for audiences ranging from health authorities to clinicians and commercial stakeholders.
- Track record of shaping scientific positioning or messaging strategy for a drug development program, ideally across multiple stages from clinical development through regulatory filing and launch.
- Strong understanding of drug development and the role of clinical, nonclinical, regulatory, statistical, CMC, and other evidence in building an integrated program story; working knowledge of relevant ICH guidelines and FDA/EU regulatory expectations.
- Strong scientific writing capability, including experience developing or providing strategic direction for high-impact clinical and regulatory documents.
- 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
$190,000—$220,000 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.