Celgene Senior Director, Product Safety Physician in Summit, New Jersey

Description

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.

JOB DESCRIPTION

Position: Senior Director, Product Safety Physician

Supervisor: VP, Therapeutic Area Head, Inflammation & Immunology

Department: Global Drug Safety & Risk Management

Key Responsibilities will include, but are not limited to, the following:

General Product Support

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

  • Oversee, prepare, and/or review aggregate safety review documents (such as Development/Periodic 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 emerging from any data source through case-series review, document analysis, safety topic reviews or other means of communication

  • Lead safety labeling activities for assigned products.

  • Act as the Safety Subject Matter Expert for input to regulatory product labeling and participate/provide input at labeling working group meetings, CCDS committee meetings and provide regional safety labeling support.

  • Support the EU QPPV or other regional or local Qualified Person for Pharmacovigilance relative to issues relating to assigned products.

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

Clinical Development

  • Act as the global safety lead for assigned compounds in development and provide safety lead support global submission document 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-focused publication development.

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

  • Actively drive safety strategy preparation for pre-NDA meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings.

Postmarketing Support

  • Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.

  • Provide medical safety, benefit-risk input and approve periodic safety update reports, product renewal submissions, postmarketing study documents and reports, responses to health authority queries.

  • Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.

  • Lead safety signaling and prepare and/or review reports on safety signals (i.e., Safety Topic Reviews) and ad hoc regulatory responses.

  • Provide postmarketing safety study guidance to other groups including pharmacoepidemiology group and medical affairs including but not limited to investigator initiated studies, epidemiology studies, non-interventional safety studies.

  • Ensure safety labeling adequately reflects emerging postmarketing safety profile.

Departmental Activities

  • Assist the GDSRM Therapeutic Area Head 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 TA staff and maintain an effective and collaborative product safety team

  • Support hiring, orientation, management, mentorship, and development of staff.

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 due diligence and potential in-licensing opportunities as requested.

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

  • Support manufacturing quality and provide quality incident medical assessments.

  • 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 such as:

  • SMT - Safety Management Teams

  • CSC - Company Safety Committee

  • PSOB - Patient Safety Oversight Board

  • TADC - Therapeutic Area Development 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/DO required

Subspecialty

Preferred

Relevant Subspecialty Training

OncologyInternal MedicinePharmaceutical Medicine

Managerial Experience

Preferred

Relevant Industry Experience

5 yrs

Drug Safety experience

minimum 2 yrs

Pharmaceutical Medicine training

Preferred. Advanced training such as DipPharm Med, ECPM is a plus

Therapeutic Area training

Subspecialty or equivalent experience relevant for the assigned product portfolio and indications, for example:Internal Medicine, Oncology, Hematology, Pediatric Medicine, Pharmaceutical Medicine.

Medical writing & review

Publicationssafety summary of submissionmajor ad hoc review (100+ pages)

Risk Management Plan

finalized

RMP implementation

follow-through experience

Risk Management Team

leader

Legal support

yes

Liaison with research

yes

Develop search strategy, initiating and reviewing searches

yes and review

Presentation to governance bodies or Health Authorities

yes

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

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.