Job ID: 14532
Location: Warren Township, NJ - 33
Full/Part Time: Full-Time
Category: Clinical - CCT
Department: Clinical Research & Dev - 3604
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
U.S. Board Certified MD (or equivalent) with advanced training in a relevant medical subspecialty (e.g. immunology), at least 5 years pharmaceutical industry, experience in clinical development (Phases 1 – 3) and experience managing direct reports and project teams. Prior experience filing an IND and/or BLA is highly desirable. Excellent organizational, communication and time management skills are needed to manage multiple ongoing projects simultaneously. Must be able to innovate, analyze and solve problems with minimal supervision and with good attention to detail.
Responsibilities will include, but are not limited to, the following:
1. Design and execute U.S. and global clinical development strategies for CCT’s human cellular investigational products (CIPs).
2. Lead a multi-disciplinary team to create draft target product profiles for CCT’s human CIPs and assemble the comprehensive data sets and analyses required to provide the CCT Scientific Advisory Board (SAB) and Cell Therapy Development Committee (CTDC) the data relevant to review, advise and endorse proposed CCT ‘s CIP development programs.
3. Possess and maintain up-to-date expertise in GCP compliant clinical trial design and execution (relevant to U.S. and EU primarily). Evaluate emerging changes and trends in the U.S. and rest-of- world drug development landscape and apply knowledge to CCT programs.
4. Lead the CCT clinical research team.
1. The Senior Medical Director has primary responsibility for coordinating the input of research, pre-clinical research, toxicology and translational medicine in to CIPs clinical research protocols and clinical development programs. He/she also oversees the input from Biostatistics and Data Management for their assigned CIP clinical studies and collaborates with other disciplines (Epidemiology, Drug Safety) to manage product development program issues .
2. Manage the clinical scientist(s), coordinator(s) and administrative assistant(s) assigned to the Senior Medical Director’s area and projects and oversee their collaboration with Celgene Clinical Operations, investigators, DMCs, KOLs and other external study research organizations.
5. Provides leadership to the larger CIP Project Team in collaboration with the Project Team Leader and theVice President of Clinical Development and Medical Affairs. The Senior Medical Director serves as a pivotal conduit of communication between internal and external stakeholders, collaborators and business partners and the project and study teams. The Senior Medical Director may also serve as team leader for projects.
6. Along with CCT’s Clinical Scientists the Senior Medical Director serves as an internal medical and disease area expert for research, pre-clinical, translational medicine, clinical study and commercialization teams on assigned projects. He/she will also be responsible to develop and maintain important relationships with external key opinion leaders, investigators and regulatory agents.
The Senior Medical Director will collaborate with Drug Safety in the development of global product safety data bases and work with Safety, Regulatory Affairs and Marketing to address product labeling issues. The senior medical director identifies issues, develops strategies and assumes or assigns projects that will pro-actively address challenges and impact CCT , its products and programs.
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
Celgene - 10 months ago
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.