Clinical Medical Monitor New United States - Remote
$260k - $335kPraxis Precision Medicines, Inc.
- Remote job
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 elevate 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 elevate, 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. 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.
$260,000 - $335,000 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. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self‑identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Praxis Precision Medicines, Inc. ’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability. A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention‑deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Public burden statement: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. #J-18808-Ljbffr Praxis Precision Medicines, Inc.$250k - $290k
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