Clinical Director Oncology , Clinical Research - Oncology European Clinical Development
Posted 5 days 21 hours ago by Merck Gruppe - MSD Sharp & Dohme
Job Description
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 a Clinical Director Oncology (Principal Scientist) to join our European Clinical Development (ECD) team. This position is for an individual scientific contributor and will report to the Oncology Therapeutic Team Leader.
You will join a dynamic and international team of other European Clinical Development Directors that work as part of the Global Clinical Development (GCD) group 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 Europe, Middle East and Africa (EMEA) Region as well as the United States, to drive the success of Oncology and Haematology clinical trials with the aim of making new and effective therapies available to 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.
Due to the scope of this role, you can be based in any of the following locations: UK (London), France (Paris), Germany (Munich), Italy (Rome) or Spain (Madrid). Other European locations can also be considered for candidates with the required skills and experience.
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 Hematology/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 (GMC or equivalent).
- Significant experience in hematology/oncology clinical development within the pharmaceutical industry; we would also consider hematology/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.
Competencies:
- Business Acumen
- Working Across Boundaries
- Strategic Thinking
- Project Management
- Communication
- Problem solving
- Research Design & Execution
- Data Analysis
- Collaboration and partnering
Travel requirements:
These roles would typically require local, regional and international travel.
Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we're inventing for life.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Closing date: 15th January 2025