Associate Director Clinical Operations

MoonLake Immunotherapeutics (NASDAQ: MLTX); Cambridge; Hybrid; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Learning opportunities in a biotech environment

Career growth and progression

Flexible work hours

Job summary

A biopharmaceutical company in Cambridge is seeking an experienced Associate Director of Clinical Operations to manage clinical study teams. This role requires significant experience in clinical operations and project management, focusing on compliance and team leadership. The ideal candidate should possess a Bachelor's degree in Life Sciences and excellent communication skills. The position offers flexibility with 2 days onsite in Cambridge or Porto and opportunities for career growth in a supportive environment.

Qualifications

• Minimum of 8 years of clinical operations experience.
• 5+ years of clinical project management experience at a sponsor or CRO.
• Experience in managing outsourced global clinical studies.
• Therapeutic experience in dermatology or rheumatology or relevant indications, ideally with biologics.

Responsibilities

• Lead the clinical study team for delivery of studies.
• Ensure compliance with protocols and guidelines.
• Communicate progress and risks to the Director Clinical Operations.
• Oversee compliance with protocol, study plans, guidelines and contracts.
• Monitor vendor deliverables and quality, escalating issues as needed.
• Develop and review study management plans to ensure sponsor oversight.
• Review vendor documents for compliance with MoonLake procedures.
• Act as key contact for study vendors and ensure timely communication.

Skills

Excellent communication skills

Highly organized

Proactive problem-solving approach

Attention to detail

Strong work ethic

Education

Bachelor’s degree in Life Sciences, Nursing or healthcare equivalent

Job description

Job Purpose

The Associate Director Clinical Operations is responsible for the management of all aspects of the Clinical Study Team activities for assigned clinical studies. 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

• Lead the clinical study team tasked with the delivery of MoonLake sponsored studies.
• 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.
• 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.
• Develop/review study management plans ensuring Sponsor oversight of clinical studies in accordance with MoonLake procedures.
• Review vendor generated clinical study related documents to ensure compliance with the objectives of the study, MoonLake procedures and relevant standards.
• 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.
• Ensure essential documents allowing the reconstruction of each study are generated, filed and maintained by or on behalf of MoonLake.
• 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.
• 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 8 years of clinical operations experience, with increasing levels of responsibility.
• 5+ years of clinical project management experience at a sponsor or CRO company.
• Substantial experience of managing outsourced global clinical studies.
• Therapeutic experience in dermatology and rheumatology or relevant indications, ideally experience of biological therapies.

Skills/knowledge/behavioural competencies

• 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 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 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 headquartered in Zug, with hubs in Cambridge & Porto.

Further information is available at www.moonlaketx.com