Clinical Development Leader, Lifecycle Management

Praxis Precision Medicines, Inc.; United States; Remote; USD 280,000 - 350,000; Full time

Benefits offered by this job

401(k) matching

Stock incentives

Discretionary bonus

Wellness benefit

Generous PTO

Company holidays

Job summary

Praxis Precision Medicines, Inc. is seeking a leadership-level clinical development executive to drive lifecycle management across late-stage and marketed assets.

You will lead cross-functional teams across clinical operations, biostatistics, regulatory, safety, and translational sciences to shape opportunities and move programs forward. You will own IND-enabling submissions, interpret emerging data, and make timely development decisions that maximize value for patients and investors.

Qualifications

• An advanced scientific degree is required (MD, PharmD, PhD or equivalent).
• A track record of personally leading clinical trials, programs, submissions or major development decisions.
• Experience with regulatory submissions and interactions with health authorities.

Responsibilities

• Lifecycle strategy: identify and drive opportunities to expand late-stage and marketed assets.
• Early development: lead first-in-human and dose-escalation studies with PK/PD data.
• Clinical entry: drive IND-enabling submissions and decisions to move programs into humans.
• Pipeline-wide leadership: work across mechanisms, indications, and phases to inform decisions.
• Data-driven decisions: interpret emerging data and make timely calls when information is incomplete.
• Cross-functional and external leadership: lead teams across clinical ops, biostatistics, regulatory, safety and translational sciences.

Skills

Clinical leadership

Regulatory submissions

Strategic decision-making

Cross-functional leadership

Education

MD/PhD/PharmD

Job description

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 escal…?
• 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.

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!

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.