Clinical Scientist in Pharma Research and Early Development (m/f/d)

Job description

·  Job facts

The position:

Pharma Research and Early Development (pRED) of Roche is structured by therapeutic areas. In Oncology, the Early Clinical Development (ECDO) 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 cancer patients. The ECDO group is part of Translational Medicine (TM) in pRED Oncology. ECDO at our site in Penzberg (RICM) is part of the globally engaged early clinical development organization in pRED Oncology.

In a nutshell:

As Clinical Scientist (CS) (m/f/d) you assist the Translational Medicine Leader in overall study planning, preparation, management, evaluation, and documentation. You will lead the full protocol development and will be the clinical science representative to participate in study management team (SMT) and clinical expert team (CET). You will also provide clinical scientific input for final study reports and annual report documentation, and assist in Health Authority (HA) briefing books, IND submissions and responses to Health Authority's (HA) questions

In this role, you will also:

·  Provide operational & scientific 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.
·  Provide training and science input to clinical operation colleagues and study site staff, and serve as trouble-shooter and expert on clinic -scientific and protocol related issues and aspects of the assigned studies
·  Write study reports and assist in preparing materials for use in presentations and advisory committee meetings, and provide response to regulatory agency questions
·  Co-ordinate, prepare, and review study results for publications, abstracts, poster presentations and scientific meetings.

Who you are:

·  You're someone who wants to influence your own development.
·  You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
·  As the ideal candidate, you bring solid clinical research experience and overall knowledge of the drug development process in oncology.
·  You are preferably medically qualified (MD), ideally combined with a PhD, or you have a PhD with clinical research work experience.
·  You also have the ability to acquire knowledge in different diseases and therapeutic areas.

Additionally, you have the following skills/ expertise:

·  5 years of clinical trial experience in a pharmaceutical company or CRO, or in the academic setting.
·  Ideally, you have successfully worked across Phase I-II drug development projects; additional experience in late stage development is a plus.
·  You are well-versed in all medical aspects of GCP/ICH, FDA, EMEA, NICE and other relevant guidelines and regulations.
·  You enjoy thinking strategically and at the same time are able to work hands on.
·  A positive mindset and understanding of the challenges in an industry environment.
·  Proactive, very flexible attitude, and you can adapt easily to change.
·  An independent, highly effective working style, and you are also a strong team player.
·  You are well known for your strong customer focus.
·  Effective verbal and written communication/ presentation skills in English are necessary.
·  You are flexible to travel internationally and to work across cultures.

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).

Application documents

For your application, please keep it simple. We only ask you for an updated CV and your relevant certificates.

Roche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.
Research & Development, Research & Development > Research

·  Who we are

Die Roche Diagnostics GmbH (RDG) ist mit mehr als 12.000 Mitarbeitern der drittgrößte Standort im Konzern. Neben den Vertriebsorganisationen in Deutschland (Roche Pharma AG und Roche Diagnostics Deutschland) fokussiert die RDG auf das operative Geschäft. In den beiden Standorten Mannheim und Penzberg werden neue diagnostische Tests und pharmazeutische Wirkstoffe für den weltweiten Markt entwickelt und produziert.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

Desired profile

Who you are:

·  You're someone who wants to influence your own development.
·  You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
·  As the ideal candidate, you bring solid clinical research experience and overall knowledge of the drug development process in oncology.
·  You are preferably medically qualified (MD), ideally combined with a PhD, or you have a PhD with clinical research work experience.
·  You also have the ability to acquire knowledge in different diseases and therapeutic areas.

Additionally, you have the following skills/ expertise:

·  5 years of clinical trial experience in a pharmaceutical company or CRO, or in the academic setting.
·  Ideally, you have successfully worked across Phase I-II drug development projects; additional experience in late stage development is a plus.
·  You are well-versed in all medical aspects of GCP/ICH, FDA, EMEA, NICE and other relevant guidelines and regulations.
·  You enjoy thinking strategically and at the same time are able to work hands on.
·  A positive mindset and understanding of the challenges in an industry environment.
·  Proactive, very flexible attitude, and you can adapt easily to change.
·  An independent, highly effective working style, and you are also a strong team player.
·  You are well known for your strong customer focus.
·  Effective verbal and written communication/ presentation skills in English are necessary.
·  You are flexible to travel internationally and to work across cultures.

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).

Application documents

For your application, please keep it simple. We only ask you for an updated CV and your relevant certificates.

Roche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.
Research & Development, Research & Development > Research

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