Head of Clinical Operations

vor 3 Monaten

Basel, Schweiz Ridgeline Discovery GmbH Vollzeit

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.


We are seeking an experienced and dynamic Head of Clinical Operations to lead our clinical operations team. This role is crucial for the successful execution of our Phase I – III clinical trials and ensuring the highest standards of quality and compliance. The Head of Clinical Operations is a strong and experienced industry expert that will lead clinical project management, medical protocol writing, regulatory document preparation, clinical SOP implementation and quality assurance with an emphasis on clinical CRO management, data transfer and site identification/initiation/training. The head will also be asked to assess, adjust, and provide leadership to the Clinical Operations function.


RESPONSIBILITIES


Leadership and Management:

  • Lead, mentors, manage and works collaboratively with Clinical Study Lead(s) and other clinical operations and supportive roles.
  • Foster an inclusive, collaborative and high-performance work environment.
  • Develop and implement relevant training programs for team members.

Clinical Trial Oversight:

  • Oversee the planning, initiation, and execution of Phase I -III clinical trials.
  • Ensure clinical trials are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and company SOPs.
  • Contribute to the preparation and review of clinical program documents (briefing books, clinical study protocol and consent forms, regulatory documents including submissions to IRBs and ECs, clinical study reports [CSR] and submissions) and other study related documents assuring quality and consistency. Monitor trial progress and address any issues that arise.

Strategic Planning:

  • Develop and implement clinical operations strategies that align with company goals.
  • Leads the development and ongoing refinement of Program level study timelines and scenarios to contribute to the CDP, IDP and other high-level strategic plans.
  • Collaborate with senior management to plan and budget for clinical trials.
  • Create and implement risk assessment and mitigation plans, performing regular reviews to continually assess for changes
  • Engage with patient advocacy groups to help build patient-focused clinical operations strategies, methods and tools for use in the clinical studies
  • Attend seminars, congresses, advocacy meetings, Investigator meetings, program and sub-team meetings, educational conferences/training sessions

Vendor Management:

  • Select, negotiate, and manage contracts with CROs, laboratories, and other vendors.
  • Ensure vendors meet performance and quality standards.
  • Overall accountability overseeing and driving CRO and other vendor relationships to ensure execution of clinical studies within the Program, within timelines, budget and with quality

Regulatory Compliance:

  • Ensure all clinical activities comply with local and international regulations.
  • Prepare and review regulatory submissions as needed.
  • Stay current with regulatory changes and updates.

Budget and Resource Management:

  • Develop and manage clinical operations budgets.
  • Ensure optimal allocation of resources for clinical trial activities.

Stakeholder Communication:

  • Serve as the primary point of contact for internal and external stakeholders regarding clinical operations.
  • Provide regular updates to senior management on trial progress and operational issues.


WHO YOU ARE


  • Advanced degree in life sciences, medicine, or a related field.
  • Minimum of 10 years of experience in clinical operations, with experience in Phase I trials.
  • Proven track record of successfully managing clinical trials from initiation to completion.
  • Strong knowledge of GCP, regulatory requirements, and clinical trial processes.
  • Excellent leadership and team management skills.
  • Strong strategic thinking and problem-solving abilities.
  • Exceptional communication and interpersonal skills.
  • Ability to travel as required.


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, cover letter, and reference letters.

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