Manager Clinical Operations

UK, PT

Full-time

Permanent employee

Job Purpose

As Manager Clinical Operations your will be responsible for the management of all aspects of the Clinical Study Team activities for assigned clinical studies. This role 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:

Support 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.
Contribute to the development of detailed project plans for the studies and work with the CRO and MoonLake team to set priorities and manage timelines.
Responsible for oversight of elements 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 when appropriate.
Monitor the status of clinical data collection of assigned clinical studies.
To support the development of 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 Manager and other MoonLake project team members as appropriate.
To ensure compliance with MoonLake procedures and SOPs.
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:

3+years of clinical project management experience at a sponsor or CRO company.
Experience of managing outsourced global clinical studies.
Therapeutic experience in dermatology and rheumatology or relevant indications, ideally experience of biological therapies would be an advantage.

Skills/knowledge/behavioural competencies:

Must possess excellent communication skills and able to effectively convey messages across to both internal and external study team members.
Highly organised, able to prioritize work, work well under pressure and meet deadlines.
Independent, self-starter with a proactive, problem-solving approach.
High attention to detail always.
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.
Some travel may be required.

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