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Associate Medical Director
vor 2 Wochen
GRANITE BIO is seeking a Associate Medical Director
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 leadership 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
- You have an advanced medical degree (MD) or equivalent
- You have at least 3 years 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 this application form together with your CV, Cover Letter and Reference Letters (Arbeitszeugnisse).
Job-ID:
GRB018
Function:
Director
