Senior Manager, Clinical Operations

2 months ago

Cambridge, United Kingdom MoonLake Immunotherapeutics Full time
Job Purpose

As a Senior Manager, Clinical Operations you are responsible for the management of all aspects of the Clinical Study Team activities for assigned clinical studies. You will work, in concert with the Director Clinical Operations, is accountable for achieving successful execution and delivery of MoonLake´s clinical development team activities at the study level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

Key Accountabilities:

  • To lead the clinical study team tasked with delivery of MoonLake sponsored studies
  • To assist in the selection of appropriate vendors for the conduct of MoonLake sponsored studies
  • Ensure a detailed project plan is in place for the studies and work with the CRO and MoonLake team to set priorities and manage timelines
  • Responsible for oversight of assigned clinical studies ensuring they are conducted in compliance with the protocol, study plans, relevant guidelines and contracts through regular vendor and/or investigator site contact.
  • To perform accompanied site/vendor visits as part of Sponsor oversight
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and escalate to the Director Clinical Operations, when appropriate
  • Monitor the status of clinical data collection of assigned clinical studies
  • To develop/review study management plans ensuring Sponsor oversight of clinical studies in accordance with MoonLake procedures
  • To review vendor generated clinical study related documents to ensure compliance with the objectives of the study, MoonLake procedures and relevant standards
  • To act as the key contact for study associated vendors and ensure timely and effective communication between involved parties
  • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements
  • To ensure essential documents allowing the reconstruction of each study are generated, filed and maintained by or on behalf of MoonLake.
  • To communicate progress and identify risks and issues arising on the assigned clinical studies to the Director Clinical Operations and other MoonLake development project team members as appropriate.
  • To ensure compliance with MoonLake procedures and SOPs.
  • Help train/mentor more junior clinical operations team members, as required.
  • Participate in the preparation, review, updating and training of SOPs and may serve as clinical operations representative for internal process/system development.


Your profile

Education: Bachelor’s degree in Life Sciences, Nursing or other health care professional equivalent.
Experience: Minimum of 5 years of clinical operations experience; with increasing levels of responsibility.

Skills/knowledge/behavioural competencies:

  • 5+years of clinical project management experience on the sponsor side. 
  • Substantial experience of managing outsourced global clinical studies.
  • Therapeutic experience in dermatology and rheumatology or relevant indications, ideally experience of biological therapies.
  • Must possess excellent communication skills and able to effectively convey messages across to both internal and external study team members. 
  • Highly organised, able to prioritise work, work well under pressure and meet deadlines.
  • Independent, self-starter with a proactive, problem-solving approach. 
  • Ability to work with little or no supervision.
  • High attention to detail at all times.
  • Must have a ‘one of a kind’ work ethic and must exhibit a great level of self-discipline.
Work Location:
  • 2 days a week in our brand new Cambridge or Porto office.
Why us?

An exciting job opportunity awaits you
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer:

Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.

Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.

Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.

Our Core Values

We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence: 

We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.

We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.

We unlock value: We aspire to create long-term value for investors and communities.

About us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.

We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.

Further information is available at www.moonlaketx.com

  • Senior Clinical Operations Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Relay Therapeutics Full time

    Senior Clinical Operations Manager - Become a key player in our dynamic organizationCompany: Relay Therapeutics is at the forefront of biopharmaceutical innovation, dedicated to creating transformative therapies for patients in need.Position Overview:Oversee the execution of clinical trials from initiation to completion, ensuring adherence to established...

  • Senior Manager, Clinical Operations Lead

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Manager, Clinical Operations to join our team at MoonLake Immunotherapeutics. As a key member of our Clinical Operations department, you will be responsible for the management of all aspects of clinical study team activities for assigned clinical studies.Key Responsibilities:Lead the...

  • Senior Manager, Clinical Operations Lead

    1 day ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Manager, Clinical Operations to join our team at MoonLake Immunotherapeutics. As a key member of our Clinical Operations department, you will be responsible for the management of all aspects of clinical study team activities for assigned clinical studies.Key Responsibilities:Lead the...

  • Senior Programme Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom School of Clinical Medicine - University of Cambridge Full time

    About the RoleThe School of Clinical Medicine at the University of Cambridge is seeking a highly skilled Senior Programme Manager to join our team. As a key member of our organization, you will play a critical role in the delivery of our clinical research programmes.Key ResponsibilitiesDevelop and implement effective programme management strategies to ensure...

  • Senior Programme Manager

    7 days ago

    Cambridge, Cambridgeshire, United Kingdom School of Clinical Medicine - University of Cambridge Full time

    About the RoleThe School of Clinical Medicine at the University of Cambridge is seeking a highly skilled Senior Programme Manager to join our team. As a key member of our organization, you will play a critical role in the delivery of our clinical research programmes.Key ResponsibilitiesDevelop and implement effective programme management strategies to ensure...

  • Senior Clinical Trial Operations Specialist

    24 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team.Key Responsibilities:Study Oversight: Collaborate with internal and external study personnel to ensure the successful...

  • Senior Clinical Trial Operations Specialist

    22 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team.Key Responsibilities:Study Oversight: Collaborate with internal and external study personnel to ensure the successful...

  • Senior Clinical Trial Associate

    5 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a pharmaceutical company that specializes in developing innovative medicines for underserved diseases. Our team is dedicated to creating a novel class of medicines, referred to as Bicycle molecules, which have shown promise in targeting specific diseases.We are seeking a highly skilled Senior Clinical Trial Associate to...

  • Senior Clinical Trial Associate

    2 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a pharmaceutical company that specializes in developing innovative medicines for underserved diseases. Our team is dedicated to creating a novel class of medicines, referred to as Bicycle molecules, which have shown promise in targeting specific diseases.We are seeking a highly skilled Senior Clinical Trial Associate to...

  • Senior Clinical Trial Operations Specialist

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job SummaryBicycle Therapeutics is seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team. As a key member of our team, you will be responsible for administering, coordinating, and maintaining the logistical aspects of our clinical study programs.Key ResponsibilitiesStudy Oversight: Support the clinical study team(s)...

  • Senior Clinical Trial Associate

    21 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Clinical Trial Associate to join our Clinical Operations team at Bicycle Therapeutics. As a key member of our team, you will be responsible for administering, coordinating, and maintaining the logistical aspects of our clinical study programs.Key ResponsibilitiesSupport the clinical study...

  • Senior Clinical Trial Associate

    19 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Clinical Trial Associate to join our Clinical Operations team at Bicycle Therapeutics. As a key member of our team, you will be responsible for administering, coordinating, and maintaining the logistical aspects of our clinical study programs.Key ResponsibilitiesSupport the clinical study...

  • Clinical Trial Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    Job DescriptionA leading clinical-stage biotechnology company specializing in oncology is seeking a highly experienced Clinical Trial Manager to join their team at the CK Group - Science, Clinical and Technical. The company has an impressive pipeline of innovative medicines across early phase development.As a Clinical Trial Manager, you will report to the...

  • Contract Clinical Trial Manager

    1 day ago

    Cambridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK Group are working with a clinical-stage biotechnology company who specialise in oncology to secure a contract Clinical Trial Manager. The company have an excellent pipeline of truly exciting and groundbreaking medicines across early phase development. Reporting to the Associate Director, Clinical Operations you will have responsibility for facilitating...

  • Contract Clinical Trial Manager

    2 weeks ago

    Cambridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    Jim Gleeson at the CK Group is working with a clinical-stage biotechnology company who specialise in oncology to secure a contract Clinical Trial Manager. The company have an excellent pipeline of truly exciting and groundbreaking medicines across early phase development. Reporting to the Associate Director, Clinical Operations you will have responsibility...

  • Senior Clinical Trial Operations Specialist

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.The company is evaluating BT8009, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting...

  • Senior Clinical Trial Operations Specialist

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.The company is evaluating BT8009, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting...

  • Clinical Trial Manager

    1 day ago

    Cambridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    Job Summary:Clinical Trial Manager - OncologyAbout CK Group:CK Group is a leading provider of scientific, clinical, and technical services to the pharmaceutical and biotechnology industries.Job Description:We are seeking an experienced Clinical Trial Manager to join our team in a contract role. The successful candidate will have a strong background in...

  • Clinical Trial Manager

    1 day ago

    Cambridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    Job Summary:Clinical Trial Manager - OncologyAbout CK Group:CK Group is a leading provider of scientific, clinical, and technical services to the pharmaceutical and biotechnology industries.Job Description:We are seeking an experienced Clinical Trial Manager to join our team in a contract role. The successful candidate will have a strong background in...

  • Senior Clinical Trial Associate

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team.The successful candidate will be responsible for overseeing the logistical aspects of our clinical study programs,...