Clinical Development Leader – Lifecycle Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Identify and pursue lifecycle management opportunities for late-stage and marketed assets, which include new indications, label expansions, and formulation prospects.

• Lead first-in-human studies and dose-escalation trials.

• Utilize pharmacokinetic/pharmacodynamic (PK/PD) data and emerging clinical information to guide dose selection, decision-making rules, and subsequent development stages.

• Oversee clinical strategy and documentation for IND-enabling submissions.

• Make critical decisions necessary for advancing programs into human trials.

• Collaborate across various mechanisms, indications, and developmental phases.

• Analyze emerging clinical and scientific data, making timely decisions even with limited information.

• Lead cross-functional teams encompassing clinical operations, biostatistics, regulatory affairs, safety, translational sciences, and other relevant fields.

• Serve as a representative of Praxis to investigators, key opinion leaders (KOLs), health authorities, and partners.

⛳️ Requirements

• An advanced scientific degree (MD, PharmD, PhD, or equivalent) is mandatory.

• Proven experience in personally leading clinical trials, programs, submissions, or significant development decisions.

• Responsibility for regulatory submissions, including clinical content for IND, CTA, NDA, or MAA filings, briefing documents, and interactions with health authorities.

• Strong judgment and the capability to make prompt decisions based on emerging data, even when information is incomplete.

• Ability to discern what issues to escalate and when to do so.

• Comfortable working in a dynamic environment where priorities and scopes can change.

• Capacity to take ownership, challenge assumptions with scientific rigor, act with urgency without compromising quality, and maintain a focus on patient outcomes.

• Regular use of computers and office equipment, clear communication skills, occasional physical movement, comfort with screen work, basic hand coordination, and sustained focus.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-paid life insurance.

• Accidental death and dismemberment (AD&D) benefits.

• Disability benefits.

• Voluntary plans for personalized coverage options.

• Dollar-for-dollar 401(k) matching up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.