Director, Clinical Pharmacology
Full/Part Time: Full-Time
Translational Dev - Clin Pharm - 3613
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.
Possess a Ph.D., Pharm.D, or MD or equivalent in the life sciences with 8- 10 years of relevant clinical research experience is required, preferable in human pharmacology.
Scope of responsibilities:
* Assume strategic responsibility for the Clinical Pharmacology components of development from a drug candidate’s nomination forward through its lifecycle management post approval.
* Materially contribute to the thinking around compound development (e.g., generate an Early Drug Development Plan before compound enters Phase I, revise and update later plans as appropriate).
* Demonstrate ability to contribute to filings and dossiers across regulatory regions, maintain currency of program requirements (e.g., safety updates, annual reports) and negotiate with functional counterparts from regulatory jurisdiction
Develop external awareness and liaisons with external scientific personnel to advance drug development. Exhibit scientific leadership in the application of clinical pharmacology (including new methodologies) to drug development. For example:
* Lead in the design, planning and execution of Clinical Pharmacology studies and their quality conduct through completion of the study report.
* Establish proof of activity and characterization of the pharmacodynamics in the clinic, using appropriate endpoints or biomarkers (including pharmacogenomics) in collaboration with Discovery, Translational Medicine and Clinical Departments.
Embrace continuous improvement (e.g., leading / participating in initiatives to improve outputs and processes) in the company.
* Design and execute pharmacodynamic (including monitoring or elucidating for non-therapeutic activity) and specialized methodologies (such as PET and other imaging scans) throughout the product development process as appropriate.
* Share responsibility for the determination of the PK/PD correlation to aid in Phase II dose selection with the Clinical Pharmaco-kineticist. Assist with design and interpretation of PK models.
* Effectively represent Clinical Pharmacology as a representative in both intra- and extra-departmental activities (e.g., Project Team)
* Share cross-functional responsibility for the characterization of the safety, tolerance, and pharmacokinetics in healthy volunteers and/or patients, (FTIH single and multiple doses). Demonstrate leadership in identifying and addressing cross-functional issues.
* Direct others as needed and appropriate in the realms of science and operations associated with drug development in clinical pharmacology.
Education / experience:
* Possess a Ph.D., Pharm.D, or MD or equivalent in the life sciences with 8- 10 years of relevant clinical research experience is required, preferable in human pharmacology.
* Demonstrate a detailed knowledge of drug development, basic pharmacology, clinical research concepts and practices, pharmacodynamics and clinical pharmacokinetics, including:
* Knowledge of FDA and international (e.g., ICH) regulations regarding conduct of clinical studies (GCP) required. Experience negotiating with regulators a plus.
* Experience within oncology or immunology clinical research is a plus.
* Have a broad knowledge of data processing methods and statistical analyses are preferred, with computer literacy a must.
Communication and interpersonal skills:
* Exhibit well developed oral communication and interpersonal skills as well as excellent writing skills.
* Demonstrate ability and willingness to work within a matrix environment and ability to function as representative on project teams are required
Strategic and operational skills:
* Demonstrate excellent analytical and problem solving skills.
* Demonstrate ability to generate innovative ideas and be able to conceptualize bridging discovery and developmental animal and human models, biomarkers, and human pharmacology techniques.
* Exhibit strong project and time management skills so that tight deadlines can be met.
* Ability to differentiate critical events at study sites, prioritize options and propose solutions as well as able to communicate effectively these issues to the appropriate parties.
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.