Clinical Development Leader, Lifecycle Management

Praxis Precision Medicines, Inc.; Northern (KY); Hybrid; USD 280,000 - 350,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability benefits

401(k) match

Stock options/ESPP

Bonus

Wellness program

PTO & holidays

Job summary

Regular travel may be required as part of cross-functional leadership and external collaborations. A strong track record of leading clinical development programs and favorable regulatory interactions will be essential. The role offers a comprehensive benefits package and competitive compensation.

Qualifications

• Advanced scientific degree required (MD/PharmD/PhD or equivalent).
• Track record of leading clinical trials, programs, submissions, or major development decisions.

Responsibilities

• Identify and drive lifecycle strategy including new indications and label/formulation opportunities.
• Lead first-in-human and dose-escalation studies using PK/PD and emerging data.
• Drive clinical strategy and content for IND-enabling submissions and human studies.
• Lead across mechanisms, indications, and phases to enable timely development decisions.
• Interpret emerging clinical data to determine what matters and escalate when information is incomplete.
• Coordinate with clinical operations, biostatistics, regulatory, safety, translational sciences and external partners.

Skills

Clinical leadership

Regulatory decision making

Cross-functional leadership

Strategic thinking

Education

MD, PharmD, PhD or equivalent

Job description

Clinical Development Leader, Lifecycle Management

United States - Remote

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 escalatestwhen.
• 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.

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.

$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.