Safety Physician

GRANITE BIO is seeking a Safety physician

GRANITE BIO is a recently established biotechnology company within the Ridgeline Discovery incubator (www.ridgelinediscovery.com) located in Basel (Switzerland). Based on fundamental research conducted over the last two decades, GRANITE BIO’s is pursuing a differentiated approach impacting central disease biology nodes to transform inflammatory, autoimmune, and fibrotic conditions.

The lead therapeutic antibody received clinical trial approval by competent authorities to initiate Ph1(b) trial in Q1/2024. We foster an open, inter-disciplinary, diverse, international and creative working environment. We enable work-from-home options according to out internal workflows.

RESPONSIBILITIES

• Perform medical monitoring and pharmacovigilance activities (such as medical oversight of the study, eligibility checks, review safety data).
• Provide causality assessments.
• Review of coding activities (MedDRA…).
• Perform safety review of clinical and diagnostic data as part of case processing and aggregate reporting.
• Provide medical review of aggregate reports (DSUR…).
• Assist with generation of project specific procedures (medical review activities).
• Contribute to design, execution/conduct and report of Ph1/2 clinical trials in I&I space.
• Contribute to medical team and clinical development strategy.
• Ensure that safety and efficacy data is generated and analyzed according to GCP/SOPs, corporate strategy and timelines.
• Work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key study milestones.
• Contribute to the development of statistical analysis plan, and in the review, interpretation, and communication of clinical trial data from clinical trials.
• (Co)-Author and develop clinical documents like, clinical study protocols and amendments and review other clinical documents like safety management plan, medical monitoring plan.
• Work closely with colleagues from Clinical Operations and Clinical Biomarker department to deliver clinical study program goals and milestones.

WHO YOU ARE

• You have an advanced medical degree (MD).
• You have at least 1 year of clinical research or clinical development experience in pharmaceutical/biotechnological industry, ideally in early clinical trials.
• You can develop collaborative working relationships with physicians, expert consultants and contracted vendors.
• You have a strong analytical mindset, excellent written/verbal communication skills.
• You have exceptional attention to detail, organizational skills and judgment.
• You have strong knowledge of clinical trial methodology, regulatory and compliance requirements of clinical trials.
• You have knowledge of Good Clinical Practices / Good laboratory Practices and clinical study design.
• You are a talented, pro-active and passionate medical professional, inspired by our shared vision to bring innovation to patients with unmet medical needs.
• You are eager to work within a dynamic and fit-for-purpose Biotech environment.
• You understand the framework and complexities of early clinical multi-centre trials and can deal with various CRO/CDO-related ways of working.
• You have ideally experience in the autoimmune disease and/or IBD (I&I) space.
• You are an effective communicator that shares information transparently and strategically.
• You are a team player and an active listener.
• You thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational.
• You apply your organizing and problem-solving skills to plan and run efficient operational and enabling aspects of clinical programs, studies, and/or enabling projects.
• You thrive leading or being an active member of large or small diverse teams.

WHAT WE CURRENTLY OFFER

• 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.
• Development: We support the individual development of our employees.
• Creativity: We offer an innovative and creative environment.
• People: We are an international and diverse team with talented and passionate people.
• Fun: From time-to-time we organise cool off-site summer and winter team events.

To apply, please send us the application form together with your CV, Cover Letter and Reference Letters (Arbeitszeugnisse).