Senior Director, Hematology/Oncology Global Drug Safety and Risk Management

Employer
Celgene
Location
Summit, NJ
Posted
Jul 10, 2018
Ref
1800585
Required Education
Doctorate/PHD/MD
Position Type
Full time

Other Locations:US- NJ- Summit East


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.

Key Responsibilities

General Product Support

  • Lead safety activities and benefit-risk strategies for assigned Celgene compounds and chair the product Safety Management Team (SMT)

  • Serve as safety lead on global development project teams for assigned Celgene compounds

  • Oversee, review, and approve aggregate safety review documents (such as Development Safety Update Reports) and safety sections of relevant clinical trial documents (e.g., protocols, Investigator brochures, informed consent forms)

  • Lead team in evaluation of signals from clinical trials data and document analysis and review through safety topic reviews and other means of communication

  • Provide input to R&D publication strategy, publication plan, and ensure safety input to publications and presentations

Clinical Development

  • Act as the safety lead for assigned compounds in development and support global submission documents production and review

  • Lead medical safety development and execution of benefit-risk management strategies for assigned products

  • Provide safety input to clinical development plans, study protocols, amendments, investigator brochure, statistical analysis plans, informed consent, clinical study reports, responses to health authority or EC/IRB queries.

  • Lead development of safety risk language, risk management plan, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety focus paper development.

  • Ensure medical safety review of development update safety reports, annual reports and other periodic safety submissions.

  • Actively drive benefit-risk strategies for pre-NDA meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings.

Departmental Activities

  • Assist Exec Dir, HemOnc, in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within Celgene R&D, and GDSRM

  • Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates

  • Assist the team and senior management in all forms of issue management and crisis management

  • Liaise with all Hem/Onc staff and maintain an effective and collaborative product safety team

Cross-Functional Activities

  • Provide input to strategic plans for safety differentiation of Celgene products

  • Co-ordinate training to Celgene employees on product safety profiles/issues

  • Provide input to potential in-licensing opportunities as requested

  • Provide product based liaison for Celgene functions (Legal, Business Development, Operations, Marketing, etc.)

  • Develop communications of safety data & interpretation to Celgene and external parties, globally

Key Relationships

  • Safety Scientists

  • Medical Safety Reviewers

  • Non-clinical experts

  • Clinical Development Physicians

  • Epidemiologists

  • Risk Management scientists

  • Global Medical Affairs

  • Regulatory Affairs

Governance

  • Participate and/or provide input to materials and strategies at meetings including but not limited to

  • SMT - Safety Management Teams

  • CSC - Company Safety Committee

  • DMC - Data Monitoring Committees - internal or external

  • PRC - Protocol Review Committee

  • Product Development Team

  • Clinical Operations Team

  • Clinical Study Team

  • Risk Management Team

Qualifications/Experience

Education

MD required

Subspeciality - Preferred

Relevant Subspeciality Training

Oncology

Hematology
Internal Medicine
Pharmaceutical Medicine

Relevant Industry Experience - 5 years

Drug Safety experience - minimum 2 yrs

Medical writing & review

Publications
Safety summary of submission
Major ad hoc reviews (100 pages)

Risk Management Plan - finalized

Safety Management Team - leader

Presentation to governance bodies or Health Authorities - yes

#LI-POST

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.