Celgene Director Research & Translational Development in Sevilla, Spain
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Director, Clinical Development is responsible for the medical monitoring of all aspects of assigned clinical trials and for providing expertise to global Research & Translational Development (R&TD) team in CITRE and to various country organizations, in the form of specialist medical expertise.
The Director offers strategic input for new therapeutic indications and for clinical development. He /she assists with the designing of the clinical strategy plan in line with the overall corporate strategy, as defined by the Clinical Development Team and regulatory requirements.
As a key member of the cross-functional disease development team he / she will provide specific medical disease knowledge for the development of the clinical development programme.
He/she also provides research support to the global R&TD team and concerning clinical studies and publications.
Responsibilities include, but are not limited to:
Responsible for the supervision and medical monitoring of studies as well as submission and interactions with health authorities.
Coordinate all activities needed to complete essential study deliverables i.e. from protocol summary until finalization of the Clinical Study Report.
Ensure that study objectives are met in a timely and cost efficient manner, in collaboration with the Study Manager, the Clinical Research Scientist and rest of the team.
Ensure the protection of research subjects and the integrity of results through compliance with company SOPs, regulatory requirements and accepted ethical standards, in collaboration with the Study Manager and team.
Ensure that studies are continuously audit/inspection ready from a medical aspect and that any resulting findings from audits/inspections are addressed appropriately.
Consult with external disease experts on clinical development plans and study design; plan and set up disease/study specific Advisory Boards and Data Monitoring and Safety Review Committees with multinational participants (primarily in EMEA region, also in NA and/or APAC as appropriate).
Provide study and disease specific training to all study team members.
Ensure CSR generation through the medical writing group. Participate in decisions regarding data structure, design, interpretation, analysis and summarization of clinical trial data.
Participate in clinical summary document generation for study specific issues, results or analysis and description of individual cases.
Cooperate closely with Clinical Operations as a member of relevant study team.
Provide Clinical Development input to commercial organization, medical affairs and IIT programs.
Support the country R&D organizations with e.g. training in close cooperation with the Country Medical Directors and Research Directors.
Medical Degree, preferably in hematology and/or oncology
Hematology/ Oncology training and experience or previous expertise in this therapeutic area
Previous experience in biotech /pharma/ academia, with related focus
Proven track record in efficient management of complex, global phase II or III multicentre studies.
Thorough knowledge of GCP/ICH and FDA/EMA requirements.
Strong leadership skills and ability to work in a matrix organization
Ability to function independently or under limited supervision
Excellent organizational and planning skills with proven experience in project management
Clear, articulate communicator with excellent written and verbal presentation skills
Multinational understanding, excellent English skills
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE