Clinical Medical Monitor

Praxis Precision Medicines, Inc.; Boston (MA); A distancia; USD 260.000 - 335.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Quarterly bonus

401(k) match up to 6%

Stock incentives

ESPP

Flexible PTO

Paid holidays

Company shutdowns

Descripción de la vacante

Praxis Precision Medicines, Inc. is seeking an experienced medical leader to provide hands-on medical oversight for assigned clinical programs. You will support investigators, review safety data, assess events, and ensure study safety and quality while maintaining independent medical judgment.

This role requires MD or equivalent, strong clinical judgment, and experience with GCP and SAEs. The position may be performed remotely with travel as needed, and offers a comprehensive benefits package

Formación

• MD or equivalent medical degree required; CNS or relevant therapeutic area experience preferred.
• Clinical trial experience with responsibility for medical monitoring, clinical safety, or related medical oversight.
• Strong clinical judgment and demonstrated ability to assess AEs and SAEs consistently and rigorously.
• Experience responding to investigator and site medical questions and making timely decisions when information is incomplete.

Responsabilidades

• Medical oversight: Provide timely medical guidance for assigned studies, including eligibility, dosing, protocol requirements, safety events, and other study-related medical questions.
• Clinical safety assessment: Review AEs and SAEs, assessing causality, severity, expectedness, clinical significance, and potential implications for patients and the program.
• Site support: Respond promptly and consistently to investigator and site medical questions, balancing patient safety, protocol requirements, and sound clinical judgment.
• Data surveillance: Review patient-level and aggregate clinical and safety data to identify trends, inconsistencies, emerging signals, and areas requiring follow-up.
• Safety and regulatory compliance: Ensure medical monitoring, safety assessment, escalation, and documentation meet applicable regulatory requirements, GCP standards, and study protocols.
• Cross-functional partnership: Work closely with clinical development, clinical operations, safety/pharmacovigilance, biostatistics, data management, and regulatory colleagues to resolve issues and support high-quality study execution.
• Independent judgment: Bring a clear medical perspective to decisions, challenge assumptions when warranted, and know what to Escalate and when.

Conocimientos

Medical oversight

Clinical trial experience

GCP knowledge

Independent judgment

Educación

MD or equivalent medical degree

Descripción del empleo

Location:

This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Great clinical development depends on strong medical judgment in the moments that matter: when an investigator has a question, a safety event needs assessment, or emerging data require action. At Praxis, you’ll provide hands‑on medical oversight for assigned clinical programs, with patient safety and study quality at the center. You’ll support investigators and sites on eligibility, dosing, safety events, and other medical questions; review clinical and safety data; assess serious adverse events; and identify emerging signals or trends. You’ll partner closely with clinical leads and cross‑functional study teams while maintaining independent medical judgment. This is a role for someone who wants to stay close to the patients, sites, and data and make timely, thoughtful decisions that keep studies moving safely and effectively.

Primary Responsibilities

• Medical oversight: Provide timely medical guidance for assigned studies, including eligibility, dosing, protocol requirements, safety events, and other study‑related medical questions.
• Clinical safety assessment: Review AEs and SAEs, assessing causality, severity, expectedness, clinical significance, and potential implications for patients and the program.
• Site support: Respond promptly and consistently to investigator and site medical questions, balancing patient safety, protocol requirements, and sound clinical judgment.
• Data surveillance: Review patient‑level and aggregate clinical and safety data to identify trends, inconsistencies, emerging signals, and areas requiring follow‑up.
• Safety and regulatory compliance: Ensure medical monitoring, safety assessment, escalation, and documentation meet applicable regulatory requirements, GCP standards, and study protocols.
• Cross‑functional partnership: Work closely with clinical development, clinical operations, safety/pharmacovigilance, biostatistics, data management, and regulatory colleagues to resolve issues and support high‑quality study execution.
• Independent judgment: Bring a clear medical perspective to decisions, challenge assumptions when warranted, and know what to Escalate and when.

Qualifications And Key Success Factors

• MD or equivalent medical degree required; CNS or relevant therapeutic area experience preferred.
• Clinical trial experience with responsibility for medical monitoring, clinical safety, or related medical oversight. The position may be hired at the Director or Senior Director level based on the depth and breadth of relevant experience.
• Strong clinical judgment and demonstrated ability to assess AEs and SAEs consistently and rigorously.
• Experience responding to investigator and site medical questions and making timely decisions when information is incomplete.
• Ability to review clinical data, recognize meaningful patterns or potential safety signals, and determine when action or additional surveillance is needed.
• Working knowledge of GCP, clinical trial safety reporting requirements, and documentation standards.
• You’ll thrive here if you stay close to the work, communicate clearly, exercise independent judgment, and take ownership. You know when speed matters, when deeper investigation is needed, and when to Escalate, all while keeping patient safety at the center.

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.

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!

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.

Annualized Base Salary: $260,000 USD - $335,000 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.