Clinical Operations Lead

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor’s degree required;, 8+ years of industry experience managing clinical trials;, In-depth knowledge of clinical study operations and ICH-GCP Guidelines;, Demonstrated experience in study management and vendor performance management..

Key responsibilities:

  • Own outcomes and drive studies from protocol design to database lock.
  • Coordinate cross-functionally with study team members and external partners.
  • Challenge existing processes and propose improvements.
  • Understand the scientific rationale and shape the execution strategy for trials.

Praxis Precision Medicines, Inc. logo
Praxis Precision Medicines, Inc. http://www.praxismedicines.com
51 - 200 Employees
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Job description

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

The Opportunity
This is a cross-functional leadership position for someone who can think clinically and act operationally — fast. It’s not a traditional “study manager” role

What you’ll be accountable for?

  • Own outcomes. Drive studies from protocol design to database lock like you’re on a mission.
  • Lead without silos. Coordinate cross-functionally with Praxis study team members and external partners to work seamlessly and break through roadblocks to study execution.
  • Challenge the default. Question timelines, vendors, processes – and propose better ways.  Don’t accept “that’s how it’s always done.”
  • Move at speed. Push execution timelines forward, not just track them
  • Sweat the strategy.  Understand the “why” behind the science and shape the “how” behind each trial. 
  • We treat this company like it’s ours – because it is.  We lead with initiative, stay invested, and deliver outcomes that make a difference.

 

Who You Are

  • A clinical ops leader who has run complex studies — but isn’t defined by your résumé.
  • Comfortable in ambiguity.
  • Fiercely collaborative, deeply accountable.
  • Thrives on urgency. Acts like patients are waiting — because they are.
  • Deeply interested in progress.

 

What You’ve Done (We care less about titles and more about impact)

  • Led global or complex clinical studies in biotech or pharma.
  • Partnered cross-functionally
  • Been part of high-functioning, fast-moving teams — or wished you had.
  • Learned from failure — and came back sharper.

 

Qualifications and Key Success Factors

  • Bachelor’s degree required;
  • 8+ years Industry experience directly managing clinical trials required. Must have worked within sponsor organization, although can be in combination with academic and CRO experience.
  • In-depth knowledge of clinical study operations, ICH-GCP Guidelines and other applicable regulatory requirements. Experience with regulatory GCP inspections desired.
  • Demonstrated experience in study management/monitoring, as well as working, negotiating and managing performance of vendors or other external partners supporting study execution
  • Intellectual curiosity: ability to think critically in a fast-paced environment, with a keen sense of urgency and demonstrated creative problem solving.

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 compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Annualized Base Salary
$170,000$200,000 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.

Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Problem Solving
  • Critical Thinking
  • Teamwork
  • Communication

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