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.
(Associate) Medical Director
Basel, CH, Tech Park HB-B
Full-time
Permanent employee
About us
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 - 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 grow
- 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