Safety physician

Ridgeline Discovery GmbH; Basel; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Benefits dieser Stelle

Prime Location Basel

Commuter Benefits

Flexible Working

Annual Leave 24 days

Zusammenfassung

GRANITE BIO, Basel-based private biotechnology company, seeks a medical professional to lead clinical monitoring and pharmacovigilance across early-phase immunology and inflammation studies. You will collaborate with physicians, CROs, and internal teams to ensure safety and data integrity.

Responsibilities include reviewing safety data, contributing to study design and protocol development, and ensuring GCP/SOP compliance.

Qualifikationen

• Advanced medical degree (MD).
• At least 1 year of clinical research or clinical development experience in pharmaceutical/biotechnological industry, ideally in early clinical trials.
• Ability to develop collaborative relationships with physicians, expert consultants and vendors.
• Strong analytical mindset and excellent written/verbal communication skills.
• Exceptional attention to detail, organizational skills and judgment.
• Strong knowledge of clinical trial methodology, regulatory requirements, and Good Clinical Practices (GCP).
• Experience with autoimmune disease/IBD (I&I) space preferred.
• Effective communicator, team player, and comfortable in ambiguous environments.

Aufgaben

• Medical monitoring and pharmacovigilance activities (oversight of studies, eligibility checks, review safety data).
• Provide causality assessments.
• Review of coding activities (MedDRA).
• Perform safety review of clinical and diagnostic data.
• Medical review of aggregate reports (DSUR).
• Assist with development of project-specific procedures (medical review).
• Contribute to design, execution, and reporting of Phase 1/2 trials in I&I space.
• Contribute to medical team and clinical development strategy.
• Ensure safety and efficacy data generation and analysis per GCP/SOPs and timelines.
• Collaborate with cross-functional teams to meet study milestones.
• Contribute to development of statistical analysis plans and interpretation of trial data.
• Prepare and review clinical documents like protocols and amendments.

Kenntnisse

Medical monitoring

Pharmacovigilance

Safety data review

Regulatory compliance

GCP

Ausbildung

MD

Tools

MedDRA

Jobbeschreibung

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 listenerYou 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.