Medical Director

Ridgeline Discovery GmbH; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Prime Location

Commuter Benefits

Flexible Working

Additional Time Off

Your Birthday Off

Coffee & Connection

Personal Development

Zusammenfassung

Granite Bio is a private biotechnology company located in Basel, Switzerland. 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.

The role involves designing, executing and reporting early-phase clinical trials in immunology and inflammation. You will guide trial protocols, support cross-functional teams, ensure safety and efficacy data are generated according to

Qualifikationen

• Advanced medical degree (MD or equivalent) required.
• At least 3 years of experience in clinical research or clinical development within the pharmaceutical or biotechnology industry, ideally with exposure to early clinical trials.
• Strong ability to build collaborative working relationships with physicians, expert consultants, and external vendors.
• Strong analytical mindset with excellent written and verbal communication skills.
• Exceptional attention to detail, sound judgement, and strong organisational skills.
• Solid knowledge of clinical trial methodology as well as regulatory and compliance requirements for clinical trials.
• Good understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and clinical study design.
• Understanding of early multi-centre clinical trials, including CROs and CDOs.
• Ideally, experience in autoimmune disease and/or IBD/inflammation and immunology space.
• Effective communicator who shares information transparently and strategically.
• Team player with strong listening skills.
• Comfortable working in a dynamic biotech environment.

Aufgaben

• Design, execution/conduct and report of Ph1/2 clinical trials in I&I space.
• Contribute to medical team and clinical development strategy.
• Provide guidance and expertise in the development of clinical trial protocols and further study relevant documents (ICF, IB, SoA, TPP, SAP).
• Ensure safety and efficacy data is generated and analyzed according to GCP/SOPs and timelines.
• Perform medical monitoring activities (oversight of study, eligibility questions, adverse event review).
• Work with cross-functional teams to ensure planning and execution of trials meet milestones.
• Develop statistical analysis plans and review/interpret trial data.
• Authorize and develop clinical documents like study protocols and amendments; review safety management and monitoring plans.
• Collaborate with Clinical Operations and Clinical Biomarker teams to achieve program goals.

Ausbildung

Advanced medical degree

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

• Design, execution/conduct and report of Ph1/2 clinical trials in I&I space
• Contribute to medical team and clinical development strategy
• Provide guidance and expertise in the development of clinical trial protocols and further study relevant documents, such as ICF, IB, SoA, TPP, SAP etc
• Ensure that safety and efficacy data is generated and analyzed according to GCP/SOPs, corporate strategy and timelines
• Perform medical monitoring activities (such as medical oversight of the study, answer questions about eligibility, review safety and adverse event data, medical oversight of coding activities)
• Work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key study milestones
• Play a key role in the development of statistical analysis plan, and in the review, interpretation, and communication of clinical trial data from clinical trials
• 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

• Advanced medical degree (MD or equivalent)
• At least 3 years of experience in clinical research or clinical development within the pharmaceutical or biotechnology industry, ideally with exposure to early clinical trials
• Strong ability to build collaborative working relationships with physicians, expert consultants, and external vendors
• Strong analytical mindset with excellent written and verbal communication skills
• Exceptional attention to detail, sound judgement, and strong organisational skills
• Solid knowledge of clinical trial methodology as well as regulatory and compliance requirements for clinical trials
• Good understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and clinical study design
• Understanding of the framework and complexities of early multi‑centre clinical trials, including working with CROs and CDOs
• Ideally, experience in autoimmune disease and/or the IBD / inflammation and immunology (I&I) space
• Effective communicator who shares information transparently and strategically
• Team player with strong listening skills
• Comfortable working in a dynamic, fit‑for‑purpose biotech environment
• Able to thrive in collaborative and sometimes ambiguous settings, with a proactive and solution-oriented mindset
• Strong planning, organisational, and problem‑solving skills, with the ability to support efficient operational execution of clinical programmes, studies, and related projects
• Enjoys contributing to diverse teams, whether in a leading role or as an active team member
• Talented, proactive, and passionate medical professional inspired by the opportunity to bring innovation to patients with unmet medical needs

What we currently offer

• Prime Location
• Commuter Benefits
• Flexible Working
• 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
• Coffee & Connection
• Personal Development
• Creative Environment
• Diverse Team
• Team Events

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