Medical Monitor / Safety physician

About us

GRANITE BIO is a private biotechnology company located in Basel (Switzerland).

GRANITE BIO is supported by top-tier investors with ~$100M raised to date. Based on fundamental research conducted over the last two decades, GRANITE BIO’s is pursuing a differentiated approach to transform inflammatory, autoimmune, and fibrotic conditions. Both our programs are first-in-class monoclonal antibodies for large market opportunities in Immunology and Inflammation. GRT-001, the lead asset, depletes inflammatory monocytes. It has just completed a Phase 1a trial in healthy volunteers and has shown favorable safety and pharmacodynamic effect. The Phase 1b trial in patients with Ulcerative Colitis has just started. GRT-002 is an IL-3 neutralizing antibody that is thought to play an important role in type II inflammation.

Our company fosters an open, inter-disciplinary, diverse, international and creative working environment. We enable work-from-home options according to our internal workflows. The successful candidate will be highly motivated and enthusiastic with a positive “can do” attitude, attention to details and innovation, strong organizational and communication skills.

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

Qualifications

• 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

Prime Location
Our modern laboratories and offices are located in Tech Park Basel – a leading hub for early-stage start-ups.
Commuter Benefits
We support your individual commuting needs with parking options or a commuter allowance.
Flexible Working
We offer flexible working arrangements where possible.
Additional Time Off
In addition to 24 days of annual leave, our offices and labs are closed between Christmas and New Year.
Your Birthday Off
Enjoy an extra day off to celebrate your birthday.
Coffee & Connection
Free coffee and a great space to connect with colleagues.
Personal Development
We support your professional and personal growth.
Creative Environment
Work in an innovative, dynamic, and creative setting.
Diverse Team
Join an international team of passionate and talented people.
Team Events
Regular off-site summer and winter events to connect and have fun together.

Please note that these benefits are subject to change at the company’s discretion and do not constitute a contractual entitlement.