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Senior Clinical Lead& Early Clinical Development

Senior Clinical Lead& Early Clinical Development

Ridgeline Discovery GmbHBasel, Basel City, Switzerland
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

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.

Reporting to the CMO, the Senior Clinical Lead is responsible for driving Six Peaks Bio’s clinical development pipeline, working closely with program leaders, internal and external experts / collaborators, and a CRO to design and implement clinical development strategies, including c linical pharmacology / translational science strategies and leading early clinical trial design .

The role will work within a cross functional project team to ensure the early definition of, and agreement on target patient profile, clinical trial design, imaging endpoints and soluble biomarker strategy, safety assessments and the overall clinical development plan.

The initial focus will be on translational medicine / science and shepherding pre-clinical projects into (early) clinical development.

This is a unique opportunity to significantly impact the future of groundbreaking therapies and contribute to plans for further expansion into other indications.

RESPONSIBILITIES

  • Acts as the champion / company medical expert for the drug candidate(s) in development
  • In close collaboration with the CMO, he / she will participate in the creation of the medical / clinical strategic plan for the targeted clinical indication(s)
  • In collaboration with Regulatory Affairs, Clinical Operations, and Project Management ensures quality input and delivery in planning of clinical development strategies, execution of clinical trials and in the preparation and submission of relevant regulatory dossiers, documents, presentations, responses and specialty publications
  • Ensure that the safety of trial participants in clinical studies is safeguarded through appropriate design of clinical studies and adequate monitoring
  • In collaboration of data management secures the highest possible integrity and quality of the collected trial data
  • Participates in collaboration with colleagues in the development and maintenance of medical science and clinical development specific global standards, processes, SOPs, quality control, to the highest level of compliance with ICH, GCP and Six Peaks Bio policies

QUALIFICATIONS

  • Medical Doctor, preferably with interest and exposure to cardiometabolic diseases
  • Possesses sound knowledge of early drug development and clinical trial processes with documented track-record of completed studies / trials / projects in which the candidate also played a strategic leader, conceptualizer, designer and implementer role
  • Solid understanding of regulatory requirements / ICH guidelines and GCP
  • Hands-on experience with written communication with health authorities like FDA (authoring an IND application, briefing books, answering questions, defending strategic positions), Institutional Review Boards and Ethical committees regarding clinical trial applications
  • Familiarity with methodologies used to assess body composition such as DEXA / CT / MRI, and commonly used / experimental biomarkers pertinent to body composition and related metabolic conditions (adipokines, inflammatory markers, measures of glucose homeostasis, insulin sensitivity, lipids, etc)

    • PERSONAL QUALITIES

  • Highly motivated self-starter with a can-do attitude and passion for innovation
  • Agile learner with ability to quickly track down, analyze and synthesize new information from different sources
  • Good planning skills, ability to anticipate next steps toward the ultimate goals
  • Able to work both independently as well as part of a team / matrix of internal and external partners / collaborators / advisors
  • Comfortable with cross-functional stakeholder management and networking across all levels of seniority with excellent communication / presentation / influencing skills

    • 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 .