Strategic Scientific Narrative Lead

Praxis Precision Medicines, Inc.; United States; Hybride; USD 190 000 - 220 000; Plein temps

Résumé du poste

Praxis Precision Medicines, Inc. is seeking a Scientific Narrative Lead to own the strategic scientific story for a lead development program, aligning data, development strategy, and regulatory messaging.

This role requires deep fluency in the program and collaboration with Regulatory Strategy, Clinical Development, Medical Affairs, and Commercial teams to craft a clear, differentiated narrative for submissions, publications, and launch readiness.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 6+ years in biopharmaceutical sponsor, CRO, or consulting in scientific/strategic communications, regulatory strategy, medical affairs, or related drug development work.
• Ability to synthesize complex data into a clear, compelling, scientifically defensible story for audiences from health authorities to clinicians and commercial stakeholders.
• Track record of shaping scientific positioning or messaging strategy for a drug development program across stages from development through filing and launch.

Responsabilités

• Own the strategic scientific narrative for a lead Praxis program, building fluency in science, data, strategy, and value to patients.
• Create a forward-looking narrative and communications roadmap linking strategy, evidence, milestones, regulatory interactions, publications, and launch prep.
• Shape scientific positioning within clinical/regulatory documents; author or lead author high-impact documents when needed.
• Set narrative direction for US/global regulatory submissions (INDs, NDAs, MAAs) with Regulatory Affairs and program teams.
• Anticipate how new data or regulatory feedback should change the scientific story and advise leadership on implications.
• Serve as a connective thread across Clinical Development, Nonclinical, Regulatory Affairs, Medical Affairs, and Commercial.
• Carry the narrative forward through launch, label expansion, new indications, and post-approval commitments.

Connaissances

Scientific narrative

Regulatory strategy

Cross-functional leadership

Scientific writing

Regulatory documents

Formation

Bachelor's degree in science

Advanced degree preferred

Description du poste

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.

$190,000 - $220,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and

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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