Celgene Senior Director, US Head of Adverse Event Case Management, Global Drug Safety and Risk Management 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.

Senior Director, US Head of Adverse Event Case Management, Global Drug Safety and Risk Management

SUPERVISOR

Executive Director, Head Global Case Management & Medical Review

DEPARTMENT

Global Drug Safety and Risk Management

PREREQUISITES

Minimum of bachelor’s degree in life sciences required

PharmD, BSN, MPH, MD, or other health sciences advanced degree preferred

Job Purpose:

  • To oversee execution of US case management activities through supervision and accountability for direct reports

  • To ensure excellence in individual case safety report (ICSR) evaluation and management to sustains excellent regulatory compliance and credibility and support safety surveillance of development & marketed products

  • To ensure effective and productive business partners collaborations through ICSR exchange

  • To help establish global standards for ICSR management

Responsibilities include, but are not limited to:

  • Senior Director US Head of Adverse Event Case Management, GDSRM is a global role based in Summit, NJ

  • Reports (at a minimum) to: Executive Director, Head of Case Management & Medical Review

Responsible for:

  • Effective acquisition, assessment, and investigation of ICSRs

  • Reporting compliance, standards, training and inspection readiness across the safety report evaluation group

  • Recruiting, retaining, developing, and mentoring AE Case Management staff

  • AE process flow, metrics and process Improvement for trials and post-market reports

  • Ensuring appropriate procedures, guidelines, and training for all Celgene staff relating to effective safety report acquisition standards

SAE/AE Case Processing

  • Ensure appropriate medical content of SAE and PMAE reports permitting case evaluation and utilization in aggregate analysis with a focus on Receipt, Triage, Assessment, and Distribution

  • Execute development and systematic improvement of SAE and PMAE data collection methods

  • Ensure Celgene sustains excellent global regulatory safety requirement compliance

  • Create resource requirement projections

  • Ensure creation of Report Evaluation group process metrics and compliance reports

  • Create, sign off and maintain policies, guidelines and SOPs

  • Hire, manage, mentor, orientate and develop Report Evaluation staff

  • Support implementation of HR processes and initiatives

  • Support internal and external auditing of Global Drug Safety & Risk Management

  • Support the development and realization of the Global Drug Safety department’s vision and long-range plan

  • Assure inspection readiness

  • Support development and execution of global safety staff education and training

Pharmacovigilance

  • Ensure corporate safety database content is comprehensive and analysis ready

  • Support the activities of pharmacovigilance MDs and Epi personnel, modifying the database output where required

Clinical Trial Support

  • Support Trials Safety Management groups in pursuit of SAE acquisition and availability for analysis & reporting

  • Support representation of SAE reports for inclusion in CSRs, ISS, update & periodic reports

  • Operationalize process agreements and work distributions with Clinical & Medical Affairs, contract research organizations & other external agents

Commercialization support and liaison to other functions

  • Ensure that management, flow, and distribution of safety information is consistent

  • Develop outsourcing / vendor selection strategies and relationships

  • Standardize safety requirements and quality oversight for key vendors

  • Contribute to the selection and evaluation of contractors

  • Maintain international collaboration, foster effective interactions with local, regional and global Celgene staff and Global regulatory authorities.

Decision Making Authority

  • Regulatory submissions and interactions

  • Content of individual safety case reports

  • Safety outsourcing strategies

  • Report based policies, SOPs and other controlled documents

  • Safety database policy & conventions

  • Group resourcing & staff appointment

  • Financial approval consistent with grade

  • Oversight of all decisions made by reports

Outputs

  • Expedited Regulatory submissions

  • Consistent SAE data across trials & safety databases

  • Safety data for use in PSURs, CSRs & ISSs and other regulatory submissions

  • Metrics & compliance reports

  • Outsourcing / Vendor Selection Plan

  • Guidelines, and SOPs

  • Organization performance documentation

Skills/knowledge required:

Qualifications, including but not limited to:

  • Minimum of bachelor’s degree in life sciences required

  • MD, PharmD, BSN, MPH or other health sciences advanced degree preferred

  • Clinical experience preferred

  • Experience- Ten (10) years drug safety experience required

  • Sustained success with management of large organizations (5 years minimum)

  • Sustained success at Director level responsibility (5 years minimum)

  • Proven ability of successful influencing and navigating cross functional stakeholders, including clinical development teams, regulatory affairs, compliance, sales and marketing, quality, global affiliates, etc.

  • Successful design and implementation of globally impactful projects

  • Mastery of global safety regulatory requirements (ICH, CIOMS, FDA, EMA, UK, ROW, etc.)

  • Key contributions to successful management of regulatory agency inspection for AE Case Management activities required

  • Pharmacovigilance systems management (e.g. ARISg, Argus) and medical coding (i.e. MedDRA) experience required

  • Understanding and experience with REMS and Risk Management Plans requirements and execution

  • Appreciation of signal recognition, statistical techniques and trials safety methods and outputs

  • Process management expertise with a continuous improvement approach

  • Experience with CAPA management in a QMS framework

  • Computer proficiency required, including using of MS Office Suite (i.e. Word, Excel, PowerPoint), WebEx, Skype

  • Ability to successfully work in global teams with remote members in other geographic regions, within the company and external to the company

  • Excellent communication skills required (speaking and writing in English)

  • Organizational management expertise, including successful direct report management, performance management, mentoring

  • Ability to influence at junior, director and executive levels

  • Occasional travel may be requested

#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.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.