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Clinical Project Lead

vor 1 Monat

Home Office, Schweiz MoonLake Immunotherapeutics Vollzeit

**Your mission**:
The Clinical Project Lead acts on behalf of the sponsor supervising all aspects of Clinical Trial activities for MoonLake’ sponsored clinical studies. The Clinical Project Lead in concert with the Clinical Development team, is accountable for achieving successful delivery of MoonLake´ clinical development activities at the project level by meeting company and regulatory requirements according to scope, quality and time.
- Proactively manage all aspects of Clinical Trial Team (CTT) including CRO/vendor selection, contract negotiation, and review and approval of invoice, managing drug supply forecast, developing ap-propriate SOPs to ensure trial conduction in compliance with regulatory requirements, and provid-ing clinical operations related training to the clinical team.
- Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meet-ing, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team mem-ber and identify opportunities to improve training, execution and quality control across the clinical team.

**Your profile**:
**EXPERIENCE AND PERSONAL ATTRIBUTES**:

- At MoonLake, we use our collective unique experience, expertise, and dedication to develop novel therapies in the smartest way, to unlock value for the company.

**The Clinical Project Lead’ unique experience would come from**:

- 8-10 years of clinical operations experience; with increasing levels of responsibility, in the Pharmaceutical/ Biotechnology industry
- Substantial years of clinical project management experience at a sponsor company, handling multinational sites’ interactions
- Therapeutic experience in dermatology and rheumatology (preferred) in Biologics
- Experience in phase II - III trials (preferred)

**We value people that are**:

- Accountable and responsible for their area of expertise and the team as a whole
- Able to balance results delivery with scientific precision, ethical rigor and transparency
- Excited about stepping up to new challenges at speed
- Courageous in thinking of how the team can achieve the impossible
- Driven to results with executional mastery and integrity, for the benefit of our community