SixPeaks Bio is a Versant Ventures and Astra Zeneca funded biotechnology enterprise focused on advancing a portfolio of antibody-based compounds targeting obesity and associated co-morbidities. The company is a preclinical stage company with a pipeline of mAbs as well as mAb-peptide conjugates entering IND preparing studies in the next few months. Our team is passionate about science and committed to improving patient outcomes through cutting-edge research and clinical trials.
Sixpeaks Bio is currently in IND-enabling studies and the FIH study is planned to start in Q1 2026.
We are seeking a reliable and motivated Senior Clinical Trial Manager to join our clinical team.
This is an exciting opportunity to work in a dynamic, multicultural, and multilingual environment, where you can actively contribute to the company’s growth and success within a collaborative, cross-functional team. This position reports directly to the Senior Director, Head of Clinical Operations.
RESPONSIBILITIES
The Senior Clinical Trial Manager will be responsible for the day-to-day operations and oversight of clinical trials, overall or at the assigned country/site level, to ensure completion through all phases (from start up to closure) on time, within budget and of high quality in compliance with all applicable regulations, ICH-GCP guidelines and standard operating procedures (SOPs).
- Oversee, monitor the deliverables and the progress of the clinical activities on the assigned country/site level or trial(s) towards the CROs and External Service Providers (ESPs) selected for the trial(s), to ensure compliance with study protocol and in accordance with scope of work/budget
- Proactively identify deficiencies or risks, and implement mitigation strategies/CAPAs in timely fashion to ensure study timelines and objectives are achieved; escalate internally, as required
- Responsible for ESPs selection and management, overseeing ESPs deliverables, performance review and KPIs
- Manage and be the main point of contact for the internal and external study-related (CRO, ESPs) teams
- Develop and/or review trial specific plans and documents
- Consolidate and provide regular updating on operational clinical trial level activities for internal reporting
- Responsible for the trial budget, accruals, forecasts in collaboration with the HCO
- Development and management of study timelines, risk and quality plans
- Contribute to prepare and formulate critical decisions, mapping out options and obtain internal approval
- Oversight of all trial files, including the Trial Master File completeness for audit/inspection readiness and investigator site files
- Forecast drug supply needs and collaborate with CMC/Drug supply team as required
- Ensure and support feasibility activities as needed
- Coordinate and manage study-related meetings
- Review study-related invoices as required
- Assume responsibility for other project or trial-related duties as assigned
QUALIFICATIONS
- Bachelor’s degree in Life Sciences, Healthcare, or equivalent; MSc is advantageous
- Fluent in both written and spoken English; additional languages are a plus
- Swiss/EU work permit required
EXPERIENCE / SKILLS
- Minimum 5 years’ experience in managing all operational aspects of clinical trials from initiation to closure
- At least 5 years of experience in clinical operations/trial management in Phase I–II interventional and international clinical trials, preferably on the Sponsor side
- Experience with U.S.-based trials is preferred
- Previous exposure to working in the metabolic field is a major asset
- Strong experience in oversight of CROs, ESPs, and third-party vendors/central labs
- Solid knowledge of ICH-GCP guidelines and the clinical trial process
- Experience with electronic data capture (EDC), electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS)
- Proficient in MS Office packages
- Strong critical thinking and problem-solving abilities
- Excellent organizational and time management skills; able to prioritize multiple tasks and goals
- Independent, proactive, and self-motivated working style
- Hands-on approach with a “can-do” attitude
- High attention to detail
WHAT WE CURRENTLY OFFER
- People: We are an international and diverse team with talented and passionate people.
- Creativity: We offer an innovative and creative environment.
- Development: We support the individual development of our employees.
- Fun: From time-to-time we organise cool off-site summer and winter team events.
- Offices: Our well-equipped laboratories and offices are located at the Tech Park, a premier address for early-stage start-ups in Basel.
- Commuter Benefits: We support our employees tailored to their personal needs in commuting to work and offer parking facilities or a commuter contribution.
- Flexible Working: We support flexible working as appropriate.
- Christmas Closure: In addition to the 24 holidays per year, our offices/labs are closed between Christmas and New Year.
- Birthday Retreat: On top of that, your birthday is your personal holiday - our employees enjoy their birthday with a day off.
- Food: We like get-togethers during lunch time. Enjoy tasty, subsidised meals from our FELFEL food fridge.
- Coffee: Meet up with your colleagues and grab free coffee.
Would you like to play a pivotal role in developing innovative therapies that could revolutionize the treatment of obesity and cardiometabolic conditions?
To apply, please submit your completed application form along with your CV and reference letters.