Celgene Sr. Director, Global Drug Safety & Risk Management, Medical Evaluation in Summit, New Jersey
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.
Reporting to the Senior Director-GDSRM Case Management and Evaluation provides medical advice and input to the activities of AE case management as well as contributes to global pharmacovigilance & trials activities through ensuring appropriate operational output and support and act as a significant point of contact for Case Management and Evaluation.
As the Global Senior Medical Director, you will, with the support of the wider organization, assist in the development and implementation of key strategies the global harmonization of GDRSM Medical Evaluation. You will be a hands-on Senior Medical Director. You will take a lead role in developing future strategies.
You will supervise a dynamic team of Associate Medical Directors, and play a key role in organizing and planning all Global Medical Evaluation communications and activities serving as a medical/scientific consultant to other departments such research project teams.
Responsibilities will include, but are not limited to the following:
Global oversight of Medical Review responsibilities including quality and compliance
Building and developing a strong medical review team
Ensuring global consistency and standards surrounding accuracy and quality of medical assessment within Case Management and Evaluation
Developing procedures in support of the Global Safety department having a significant medical context
Execute the medical review of AE reports (narrative, coding, labeling, causality, Pharmacovigilance comment) and manage corrections with Assessment as applicable
Confirm SUSARs and manage unblindings from double blinded studies
Contribute to solving reconciliation coding issues/discrepancies
Provide input to PSURs as required
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
Develop targeted questionnaires in collaboration with Lead Safety Physician
Participate in product meetings.
Establishes the criteria essential for determining the safety assessment across therapeutic areas throughout the product lifecycle
Ensure inspection readiness
Demonstrated ability to manage and motivate team members
Demonstrated advanced ability to problem solve, influence and implement solutions
Complete understanding of the global regulatory requirements pre and post marketing.
An advanced understanding of drug development principles and clinical trial implementation and management as well as working knowledge of marketing and commercialization
Working knowledge of associated disciplines, including biostatistics, data management, and medical writing.
Clinical knowledge of therapeutic area patient populations
Proficiency in signal recognition and statistical techniques
Issue and crisis management
Ability to work across different therapeutic areas
Excellent written and oral communication skills
Strong analytic and presentation skills.
Strong computer skills with demonstrated experience working in a safety database
Working knowledge of MedDRA, WHO-DD is strongly preferred. Knowledge of clinical data management processes is preferred.
Working knowledge of coding tools is a plus
Knows how/when to apply organizational policy or procedures to a variety of situations.
M.D., with at least 10 years of experience in the pharmaceutical industry within Global Pharmacovigilance.
Five (5) years Prior Management Experience (global experience preferred)
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.
Sr. Director, Global Drug Safety & Risk Management, Medical Evaluation
Location: Summit, NJ, US
Job ID: 17001572