Associate medical director

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)
.