Clinical Director, Clinical Research
vor 7 Monaten
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we ‘follow the science’ and that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.
We are currently recruiting for one **Oncology Clinical Director **to join our European Clinical Development (ECD) team. This position will report to the Oncology Therapeutic Team Leader.
You will join a dynamic and international team of other ECD Clinical Directors that work as part of the Global Clinical Development (GCD) Team and other key functions to run global late stage clinical trials in oncology. You will operate in a highly collaborative environment, partnering with peers throughout the European, Middle East and Africa (EMEA) Region as well as the United States, to drive the success of oncology clinical trials with the aim of making new and effective therapies available for patients. You will also be able to supplement your research activities by taking advantage of the technologies and capabilities of the wider company network of sites and colleagues.
**Primary Activities**:
- Protocol development and medical/scientific oversight of clinical research studies involving new and marketed drugs being developed within the oncology therapeutic area.
- Provide European perspective and input on protocol design and support recruitment and study management activities in the EMEA region including global study program leadership.
- Responsible for all phases of the trial process, including but not limited to the design, oversight and medical monitoring of Phase I to III clinical trials, as well as analysis, interpretation and reporting of final clinical trial results.
- Presentation of research findings at international scientific meetings and providing European clinical insights from a network of scientific directors and oncology societies into our development programs.
- Member of relevant Clinical Sub Teams (CST), Clinical Trial Teams (CTT) and an _ad hoc_ attendee at Product Development Team (PDT) meetings
- Active collaboration with other clinical teams, Global Trial Operations (GTO), EMEA Global Clinical Trial Operations (GCTO) Regulatory Affairs, Safety Risk Management, Global and Local Scientific Affairs and Medical Affairs
- Work closely and align with the relevant Global PDT / Clinical Science Study Management (CSSM) indication specific leads on EMEA regional clinical trial assignments.
- Identify, establish and maintain collaborative scientific relationships with key investigators, institutions, groups and consortia to identify and address scientific needs and stay abreast of current scientific trends in oncology.
- Contribute to establishing oncology clinical development strategies and executing on short
- and long-term research objectives.
- Support in creating a community of physicians within the organisation - from development to country-based medical directors, medical affairs managers and medical science liaisons.
- Fully comply with all company policies and applicable laws, regulations, and ethical standards.
**Qualifications**:
**Education**:
**Required**:
- Medical Degree
**Preferred**:
- Additional advance degree, e.g. MSc, PhD
**Experience and skills**:
**Required**:
- Medical doctor with a license to practice/board certified
- Significant experience in oncology clinical development within the pharmaceutical industry; we would also consider oncology clinical development experience derived from a clinical setting, alongside pharmaceutical industry experience.
**Preferred**:
- Research background in design and implementation of clinical studies, familiarity with biostatistics, and/or European Medicines Agency (EMA)/Federal Drug Agency (FDA) regulatory review process is desirable
- Clinical/translational research experience with evidence of strong scientific productivity such as authorship on published manuscripts. Previous experience in Gynecologic Cancer is highly desirable.
**Ways of Working/Competencies**:
- ** Silos to networks**: collaboration and building partnerships with internal and external stakeholders
- ** Planning to experimentation: p**rocess improvement and decision making
- ** Withholding to sharing** strong interpe
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