Director, Clinical Research Physician, Inflammation & Immunology Job
Celgene - Township of Warren, NJ

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Job Title:
Job ID: 13335
Location: Warren Township, NJ - 33

Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Inflammation - 3608

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.

Prerequisites:
  • MD with minimum of five years of relevant pharmaceutical/biotech industry experience, with an excellent understanding of the clinical drug development process.
  • A medical subspecialty in GI or Rheumatology is preferred, but not required.
  • Prior industry experience in Late Clinical Development or Medical Affairs is helpful, but not required.
  • Excellence in technical writing and oral presentation of technical material is an essential requirement.
BASIC RESPONSIBILITIES:
The Clinical Research Physician manages and supervises the clinical science and technical activities required to design, execute, analyze, and report clinical studies, with emphasis on overall clinical science leadership. This work is carried out at the direction of the VP of Early Clinical Development in line with the departmental strategic goals. This person also ensures quality, timely and coordinated clinical study activities within Celgene Corporation and ensures compliance with the appropriate GCP/ICH and health authority guidelines, within areas of the responsibility for this position. This individual provides clinical development expertise on behalf of the company and represents Celgene Corporation at appropriate academic centers, medical and regulatory meetings.

The Clinical Research Physician in I& I Early Development is responsible for collaborating with, and insuring the successful interface with the Departments of Clinical Pharmacology and Translational Medicine, but is not responsible for design, execution, analysis of clinical studies in these Departments. In situations where clinical pharmacology studies must be performed in patients instead of healthy volunteers, the I&I Clinical Research Physician may share responsibility with Clinical Pharmacology, such as medical monitoring, but Clinical Pharmacology would still retain ownership of design and analysis of these trials.

The Clinical Research Physician is also responsible for assisting the VP of Early Clinical Development in establishing and achieving long-term Corporate Strategic goals and tactical objectives.

SPECIFIC DUTIES:
  • Provides medical leadership to the clinical study team in the design, execution, analysis, and reporting of clinical studies.
  • Oversees and is responsible for the quality, coordination, timeliness of the medical aspects of protocol development and clinical study reports.
  • Collaborates with members of the Safety Department and participates in the evaluation of safety results in clinical studies and contributes to formulations of the emerging safety profile and risk/benefit profile of products in development for clinical trials and regulatory documents such as the IND, Investigator Brochure, Informed Consent, etc.
  • Contributes written sections and assists the VP to oversee quality, coordination and timeliness of clinical sections of protocols, Clinical Study Reports, INDs, Investigator Brochures, CTAs, ISS’s ISE’s, other regulatory submissions and clinical expert reports.
  • Collaborates with and supports Data Management as required for CRF development, database edit checks development, listings review, query resolution, database clean-up and lock activities.
  • Collaborates with Biostatistics on study design, data analysis, and reporting.
  • Prepares clinical study timelines and status reports, as required, per Supervisor.
  • Identifies and justifies potential new indications for existing or new drug candidates
  • Leads writing of clinical development plans in collaboration with project team members
  • Participates as a clinical representative on Project Teams.
  • Establishes and maintains working relationship with Study investigators, key opinion leaders, academicians, and Celgene Senior managers and department heads across the corporation.
  • Ensures adherence to GCP/ICH and Celgene SOPs within areas of the individual’s responsibility.
  • Maintains clinical and scientific awareness in therapeutic areas of interest to the Department.
  • Maintains awareness of worldwide regulatory requirements and trends in Guidance applicable to clinical development in therapeutic areas of interest to the Department.
  • Supports Clinical Operations in site selection, study budget preparation, study execution and addresses clinical/medical issues at study sites.
  • Participates in the organization, coordination and execution, as required, of internal Celgene meetings and external medical/scientific meetings, e.g., Investigator Meetings and clinical/scientific advisory board meetings.
  • Develops and gives oral presentations to internal or external audiences, as required.
  • Collaborates with external and internal partners, contributes to data analysis to create and submit clinical study results in publications.
The position requires an individual with:
  • MD with a minimum of 5 years of relevant pharmaceutical/biotech industry experience with an excellent understanding of the clinical drug development process.
  • Excellence in technical writing and oral presentation of technical material is an essential requirement.
  • Exceptional skills and expertise in searching medical literature and databases for clinical and technical information with knowledge of and experience in experimental clinical study design, including a solid foundation of understanding of statistics and statistical methods as applied in clinical research.
  • Ability to anticipate and identify issues and hurdles that may handicap the effective implementation of the clinical trials, and to resolve issues in a timely and effective fashion.
  • Knowledge of and strict adherence to GCP/ICH guidelines and internal SOPs in Clinical Development.
  • Excellent managerial and leadership skills appropriate to a matrix management environment, or exhibits potential to develop such skills.
  • Excellent verbal communication skills to effectively represent Celgene at a corporate level, with internal working groups/project teams and external academic/industrial/regulatory organizations.
  • Excellent technical writing skills.
  • Team player, possesses sense of urgency and tenacity, and exhibits potential for mentoring others. Ability and desire to work in a growing organization in which initiative is expected and responsibilities are often shared. Ability to multi-task and manage multiple projects in parallel, with a high degree of attention to detail, and with a strong sense of discrimination among potentially competing priorities.
Skills/Knowledge Required:
ORGANIZATIONAL/JUDGEMENT:
Must have planning skills to prioritize and schedule activities to meet Clinical Development and project team deadlines. The position requires problem solving ability, and skills to address medical, clinical study and technical questions in a multi-disciplinary environment. Must be comfortable with assessing data and making evidence-based decisions with incomplete, ambiguous, or contradictory information that typifies experimental clinical science, especially in early clinical development. Must be technically proficient with standard PC software (Word, Excel, PowerPoint). Must keep abreast of medical and scientific literature and regulatory requirements and trends within the relevant therapeutic areas. Must maintain the highest ethical standards, personal integrity, and intellectual honesty at all times.

SUPERVISION:
Supervises internal staff in a matrix organization, as required. Also may interface with CRO’s, academics, and external experts as appropriate, to provide guidance, direction, and collaborative or collegial support.

ACCOUNTABITY:
This position has responsibility, under supervision of the VP of Early Clinical Development, for the quality, timeliness, medical/scientific accuracy of clinical study design, execution, analysis and reporting. This position has cross-functional accountability to the clinical study team and project team, as required. This position must ensure GCP/ICH compliance.

INTERNAL:
Frequent contact with various levels of R&D as well as moderate contact with colleagues in other departments (regulatory, drug safety, project management, toxicology, pharmacokinetics, translational medicine, drug discovery, marketing, finance, business development, etc) at Celgene is required.

EXTERNAL:
Moderate contact with Clinical Investigators and Clinical Site Staff, CRO’s, academicians, external experts and appropriate professional groups is necessary.

Travel:
Domestic and international travel is mandatory, as may be required.

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.

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About this company
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.