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Jobs / Clinical Operations Manager in United States of America
3 days ago
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Lindus·3 days ago
3 days ago

Senior Director of Clinical Operations

USFull-timeRemoteSenior · 15+ yearsClinical Operations Manager

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Top 10% of NextRaise users matched against Clinical Operations Manager roles in United States.

Must-have skills for this role

  • clinical operations
  • etmf
  • regulatory execution
  • edc

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Apply faster with autofill FREElindus uses Ashby - autofill it instead of retyping.careers.example.com/applyAutofillingFull namePriya SharmaEmailpriya.sharma@example.comPhone+49 30 1234567LocationBerlGet the extension

What you'll do

  • Own the delivery of the trial for one of our assets - accountable for its clinical and regulatory execution, its quality, and its delivery on time and on budget.
  • Work closely with and line-manage the Clinical Program Manager running the trial day-to-day
  • Proactively spot and mitigate risks by contributing to the assets clinical development plan, maintaining good collaboration with Programme Directors in the Corp Dev team
  • Build clinical operations and regulatory capability as we move into more complex, FDA-facing trials - raising the bar on monitoring, oversight and quality across the Clinical Operations team
  • Accountable for and input into ClinOps SOP and process design across the portfolio, partnering closely with our Director of Quality
  • Work closely with tech and product teams input into Citrus and other tools and system design from a clinical delivery perspective
  • Guide, mentor and support professional development of the wider ClinOps team
  • Portfolio ClinOps Sign-off - Senior authority on operational and quality decisions and sign-off across every trial in the LTx portfolio, covering safety, trial design and proportionality, plus sign-off on essential trial documentation and quality issues. Collaborate effectively with cross-functional leads to solve issues that arise.

What they're looking for

  • 15+ years in clinical operations, with genuine hands-on delivery across multiple Phase 2 drug trials.
  • Experience with complex neurology trials in chronic indications, ideally in Parkinson’s disease
  • Real, first-hand experience making clinical, quality and safety judgement calls in real time across a range of trials.
  • A track record of senior review and sign-off on essential trial documents - monitoring plans, RAMPs, protocol deviations, eTMF readiness.
  • A proportionate, risk-based approach to clinical oversight - you focus on what's actually risky, not on ticking every box.
  • A track record of contributing to or leading SOP and process design at a portfolio or function level, not just following processes someone else wrote.
  • Broad experience across trial types, phases and therapeutic areas, with the judgement to advise operators more junior than you without taking the decision away from them.
  • Comfortable shaping the tools you work in, not just using them - you've influenced how trial systems (EDC, CTMS, eTMF) get built, not only adapted to what's there.
  • Genuinely energised by a portfolio-wide authority role - shaping safety, process and clinical judgement across every asset - and equally happy to get hands-on running a trial of your own once you're ramped in.

Nice to have

  • Experience across multiple regulatory jurisdictions is a strong plus, with FDA preferred

Summarised by NextRaise from the employer’s description, which follows in full below.

Full description from employer

🍊Our mission

Great science regularly stalls in the clinic, not because the science is wrong, but because the company behind it lacks the capital, infrastructure, or focus to take it all the way through. Today’s clinical-stage biopharma model is broken, and as a result promising treatments never reach patients.

Our mission is to fix this: we’re building the next generation of biopharma by in-licensing clinical-stage therapeutic assets and developing them through Lindus Health’s integrated, technology-first clinical trial infrastructure. We’re a new initiative, but we’re building on a proven foundation - the same infrastructure that has delivered 82% of Lindus Health’s sponsor trials on or ahead of timeline, across 40+ completed trials across the US and Europe.

We’re in-licensing 5-7 clinical-stage, typically Phase-2-ready assets, funded directly from Lindus Health’s balance sheet. We’re targeting deal close on our first assets through 2026, with first trials launching in H1 2027.

🍊About the role

We're looking for an exceptional Senior Director of Clinical Operations to take personal ownership of the clinical delivery of one of our five in-licensed assets, running the trial from start-up through to close-out.

You'll be accountable for that trial's clinical and regulatory execution, its quality, and its delivery on time and on budget, working closely day-to-day with the Clinical Program Manager running it and stepping in wherever a call needs to be made, whether that's on safety, protocol interpretation or trial methodology. Alongside your own asset, you'll bring that hands-on delivery experience to the wider portfolio, acting as a senior voice on our SOPs, quality bar and systems, and as a source of counsel for other trial teams.

You'll collaborate closely with members across the business, including our Chief Medical Officer, our ClinOps team across five assets, our Director of Quality, and our Product team, and you'll report to our VP Operations.

🍊About you

We'd like to hear from you if…

  • You have high agency and a bias for action

  • You are passionate and curious about our mission; changing how the healthcare industry operates and how new health treatments are developed

  • You want to learn what life is like at a high-growth, mission-driven, VC-funded startup

You belong here! If your experience and interests match with some of the below, we want you to apply:

  • 15+ years in clinical operations, with genuine hands-on delivery across multiple Phase 2 drug trials.

  • Experience with complex neurology trials in chronic indications, ideally in Parkinson’s disease

  • Real, first-hand experience making clinical, quality and safety judgement calls in real time across a range of trials.

  • A track record of senior review and sign-off on essential trial documents - monitoring plans, RAMPs, protocol deviations, eTMF readiness.

  • A proportionate, risk-based approach to clinical oversight - you focus on what's actually risky, not on ticking every box.

  • A track record of contributing to or leading SOP and process design at a portfolio or function level, not just following processes someone else wrote.

  • Broad experience across trial types, phases and therapeutic areas, with the judgement to advise operators more junior than you without taking the decision away from them.

  • Comfortable shaping the tools you work in, not just using them - you've influenced how trial systems (EDC, CTMS, eTMF) get built, not only adapted to what's there.

  • Genuinely energised by a portfolio-wide authority role - shaping safety, process and clinical judgement across every asset - and equally happy to get hands-on running a trial of your own once you're ramped in.

  • Experience across multiple regulatory jurisdictions is a strong plus, with FDA preferred


🍊 What you'll focus on

  • Focus area 1: Clinical Operations Leadership on an Asset

    • Own the delivery of the trial for one of our assets - accountable for its clinical and regulatory execution, its quality, and its delivery on time and on budget.

    • Work closely with and line-manage the Clinical Program Manager running the trial day-to-day

    • Proactively spot and mitigate risks by contributing to the assets clinical development plan, maintaining good collaboration with Programme Directors in the Corp Dev team

  • Focus area 2: Clinical Operations SME

    • Build clinical operations and regulatory capability as we move into more complex, FDA-facing trials - raising the bar on monitoring, oversight and quality across the Clinical Operations team

    • Accountable for and input into ClinOps SOP and process design across the portfolio, partnering closely with our Director of Quality

    • Work closely with tech and product teams input into Citrus and other tools and system design from a clinical delivery perspective

    • Guide, mentor and support professional development of the wider ClinOps team

  • Focus area 3: Portfolio ClinOps Sign-off - Senior authority on operational and quality decisions and sign-off across every trial in the LTx portfolio, covering safety, trial design and proportionality, plus sign-off on essential trial documentation and quality issues. Collaborate effectively with cross-functional leads to solve issues that arise.

🍊 What we offer

Make an impact across all areas of our business and fix one of the world's most broken industries.

  • Competitive salary, plus meaningful stock options

  • 27 days annual leave in addition to 11 National Holidays

  • Health insurance coverage through our PEO Trinet

  • $40 monthly wellness allowance, which you can spend on a wellhub membership, or wellness activities and expenses of your choice!

  • Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver

  • $2,000 Learning and Development allowance each year to put towards courses, certifications, and development

  • Regular whole company and team events, both in person and virtually

  • Access to gym and retail discounts through our benefits platform Happl

  • Monthly lunch voucher for our remote teams

  • Charity events and fundraising opportunities through our charity partnership with the Forward Trust

🍊 Our hiring process

  • Initial conversation with Cam, our Senior Talent Partner (30 minutes)

  • Second interview (45m) with Hannah, VP Operations, and Tessa

  • Functional Interview (60m) with Luke, CMO, and Shane, head of Quality

  • Values interview with 2 team members (30 minutes, Meri competencies with Gemma/Veronica)

We will only contact you from lindushealth.com email addresses. Please check the spelling of emails which appear to come from Lindus carefully before responding. We will never ask for your financial information over email.

We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status

Company

Lindus
US

Company facts come from this company's own listings. We only show what the postings themselves carry.

Sourced from Lindus's careers site·first seen 17 Sept 2026·last verified 17 Sept 2026·How we source jobs

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