Medical Director
vor 4 Monaten
**Your Tasks and Responsibilities**:
You will strengthen our clinical development department and will play a key role in driving the development of novel immuno-oncology therapeutics from IND-enabling through early clinical development. As a Medical Director you will report to the Chief Medical Officer. Your tasks will include:
- Plan and execute the clinical development plans of iOmx ensuring that projects are completed on time and to budget.
- In close alignment with the CMO, you oversee the planning and management of clinical trials, including study design, trial management and interpretation of results.
- Management of a cross-functional clinical development team (clinical operations, data management, safety reporting, etc.) to define and execute clinical trial activities that best support the overall development strategy. Mentor and develop assigned staff, as appropriate.
- Selection and oversight of external vendors (CROs) that support iOmx during clinical trial execution is a key aspect of the position.
- Work with study sites and investigators to ensure efficient performance and completion of clinical studies.
- Support the review, analysis and interpretation of study data and communication of study results.
- Support project budget planning and monitoring in collaboration with the project leader.
- Interaction with EU regulatory authorities and FDA including responsibility for regulatory documents relating to the medical area (e.g. clinical study protocol, IB, briefing book).
- Provide medical input to regulatory submissions.
- Operational tasks as a member of the clinical development team.
**What we are looking for**:
- Medical Doctor (MD) with board certification.
- Ideally, experience in the pharmaceutical or biotechnology industry, with a focus on immuno-oncology drug development.
- Proven track record of successfully leading clinical drug development programs, from early-phase to late-stage development, including interactions with regulatory authorities.
- Working knowledge of GCP, scientific methodology, protocol design, as well as regulatory requirements.
- Documented hands-on and strategic/scientific experience in immuno-oncology and predictive biomarker-driven development strategies.
- Clinical development and translational experience with small molecules and biologicals. Strong in translational science, as well as operational execution.
- Experience with data analysis and interpretation, including a solid understanding of biostatistics and clinical trial design.
- Strong leadership, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and outside experts.
**Why to join iOmx?**:
We are a young biotechnology company with about 50 employees in Martinsried/Munich. We are working in flat hierarchies with short decision-making processes and offer a rewarding career in a welcoming, trusting and international work environment.
By joining us you can expect the following:
- Opportunity for personal development
- Growth-oriented and innovation-driven company culture
- 30 days paid vacation
- Flexible working time and much more
**About us**:
- i_
- Omx Therapeutics is a clinical-stage company in the field of immuno-oncology located in Martinsried/Munich, Germany._
- We are focusing on the development of first-in-class cancer immunotherapies, addressing novel immune evasion biologies, which are hijacked by tumors and their microenvironment._
- We are looking for highly motivated, self-driven and competent colleagues who share our vision and wish to contribute to translating this vision into reality._
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