Pharma Research and Early Development (pRED) of Roche is structured by therapeutic areas. In Oncology, the Early Clinical Development (ECD) group is responsible for developing and executing the early development (Phase I-II) clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. The ECD group is part of Translational Medicine (TM) in pRED Oncology.
ECD at our site in Penzberg is part of the globally engaged early clinical development organization of TM in pRED Oncology. The Clinical Scientist (Translational Medicine Scientist (TMS) participates in the development of the Clinical Development strategy and plans and supports the assigned Translational Medicine Leader (TML) with various deliverables necessary for effective and efficient execution of the clinical development plan for the assigned molecules or indications.
In a nutshell:
The Clinical Scientist (TMS) has primary responsibilities for supporting ECD/TML with clinical documentation, representing clinical science on various sub-teams or other appropriate forums, supporting medical training of study site personnel, acting as a primary point-of-contact for questions and inquiries to ECD regarding ECD studies or other programs (also for external inquiries e.g. from study sites and health authorities), conducting ongoing medical/safety data reviews, and providing clinical/medical science input into study reporting. Clinical Scientists (TMS) are expected to perform their responsibilities independently and need to be able to substitute and deputize for the TML.
In this role key responsibilities include, but are not limited to the following tasks:
- You will provide operational and scientific leadership expertise in all aspect of study planning, evaluation and documentation for a number of assigned global Phases I-II oncology studies within the agreed strategy, budget and timelines
- You will be responsible for at least one clinical study
- Furthermore, we ask you to lead the clinical protocol development process by engaging line function input at the appropriate time
- It is up to your hands to retain operational and scientific input into the finalization of clinical development plans and study related documents, including but not limited to investigator brochures, IND annual reports, Health Authority (HA) briefing books, IND submissions and responses to Health Authority’s (HA) questions
- It will be your responsibility to lead the clinical trial data and medical-scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/ external presentations, jointly with the Translational Medicine Leader (TML)
- We ask you to energize and to provide direction to the global multidisciplinary, cross-functional Study Management Team (SMT) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedure, within a matrix environment
- Furthermore, you will serve as contact for the global Roche Medical Emergency Center for medical questions/emergencies affecting patients on clinical trials
Who you are:
- You hold a MD, or MD plus PhD in a biomedical or life sciences discipline (MD degree is mandatory as you need to be able to be the medical responsible for individual molecules, e.g. towards health authorities and in order to be able to serve as Roche Medical Emergency Contact). This implies solid experience in direct patient care preferably in oncology or hemato-oncology.
- Furthermore, you have more than 5 years of clinical trial experience in a pharmaceutical company or CRO, or in the academic setting
- We can trust in your extensive knowledge of clinical research and you have successfully worked across Phase I-II drug development projects; additional experience in late stage development is a plus
- Knowledge about the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.) is natural to you
- Your data listing experience comes in addition to your know-how in authoring aspects of a global clinical development plans or full clinical study protocols as well as in publishing results of clinical drug trials in a referred journal
- You are well-versed in all medical aspects of GCP/ICH, FDA, EMEA, NICE and other relevant guidelines and regulations
- You are excited about science and open to explore and adapt based on novel findings. Furthermore, you are excited about working in an ever changing and increasingly complex environment.
- We can trust in your comprehensive understanding of product and safety profiles
- Furthermore, you are able to work independently and to provide leadership/ direction to multidisciplinary clinical trial teams within a complex matrix environment
- Working in a highly collaborative environment is also one of your strong points
- Analytical thinking is one of your strengths and you have excellent planning and organizational skills
- You are well known for your strong customer focus
- Furthermore, we can trust in your highly effective team work and interpersonal skills
- You are flexible to travel internationally and to work across cultures
- Effective verbal and written communication/ presentation skills in English are necessary
We look forward receiving your application!
Whom to contact
E. Hallermayer-Jahreiß +498856/60 19253
For technical questions, you can use our FAQ
Should you have recruiting specific questions on your application or the specific job posting, please contact the responsible recruiter (E. Hallermayer-Jahreiß, +498856/60 19253).
For your application, please keep it simple. We only ask you for an updated CV. All further relevant documents, such as certificates, reference letters etc. will be handled at a later stage.