Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience

Bristol Myers Squibb•Princeton, NJ

1d•$334,860 - $405,769•Onsite

About The Position

The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. This role provides strategic oversight and delivery of medical safety assessment for assets in the therapeutic area (TA) by effective management of a safety physician team. The role oversees safety activities and benefit-risk strategies for assigned compound(s)/program(s) and chairs the product/TA Safety Management Team (SMT).

Requirements

MD/equivalent required.
Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable.
7+ years in pharmacovigilance (PV) or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.
Management experience is strongly preferred.
Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.
Extensive understanding of the drug development process.
Expert knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
Skilled ability to direct (and leverage) range of available tools to investigate safety concerns, including the science of observational research.
In-depth understanding of regulatory requirements for safety assessment and action.
Expert scientific analytical reasoning skills.
Ability to manage (and work on) multiple complex projects in parallel.
Excellent attention to detail.
Behavioral competencies necessary to work and lead within a complex matrix environment.
Excellent verbal and written communication skills.

Nice To Haves

Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable.

Responsibilities

Oversee safety activities and benefit-risk strategies for assigned compound(s)/ program(s) and chair the product/TA Safety Management Team (SMT).
Oversee, Review, and Approve aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).
Oversee team in evaluation & management of signals emerging from any data source.
Guide strategy for signal evaluation (eg, case-series, literature review, HA/ claims database).
Ensure documentation by Safety Topic Review/Signal Report or other means of communication.
Approve safety labeling activities for assigned products.
Provide Safety Subject Matter Expertise for input to regulatory product labeling.
Support the EU QPPV or other regional or qualified person for PV relative to issues relating to assigned products.
Provide input to R&D publication strategy/ plan & ensure safety input to publications/ presentations.
Oversee the global safety strategy for assigned compounds in development.
Support global submission document production.
Review final summary documents.
Oversee medical safety development and execution of benefit-risk management strategies for assigned products.
Review safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plans (SAP), ICF, clinical study reports (CSR), responses to health authority (HA) or institutional review board (IRB)/ ethics committee (EC) queries.
Oversee development of safety risk language, risk management strategy, 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 DSUR, annual reports, and other periodic safety submissions.
Represent WWPS at HA meetings.
Actively drive benefit-risk strategies for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.
Oversee the lifecycle safety strategy for assigned marketed compounds and support global postmarketing safety activities and submissions.
Provide medical safety, benefit-risk input and approve DSUR/PBRER, product renewal submissions, postmarketing study documents, and reports, responses to HA queries.
Provide medical safety oversight of and execution of risk management strategies and risk management plan (RMP) elements for assigned products.
Oversee safety signal evaluation & management.
Review and Approve reports on safety signals (ie, Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses.
Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs, including but not limited to investigator sponsored research/ trials (IST), epidemiology studies, and non-interventional research.
Ensure safety labeling adequately reflects emerging postmarketing safety profile.
Drive change in the organization and adoption of new processes.
Assist the MSA TA Head in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.
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 patient safety team.
Hire, Orient, Manage, Mentor, and Develop staff.
Identify data gaps and Prioritize data acquisition.
Provide input to strategic plans for safety differentiation of BMS products.
Oversee and/or provide training to BMS employees on product safety profiles/issues.
Provide input to due diligence and potential in-licensing opportunities as requested.
Act as WWPS TA liaison for assigned products with BMS functions (Legal, BD, Operations, Marketing, etc.).
Support manufacturing quality.
Review integrated health hazard assessments.
Review communications of safety data & interpretation to BMS and external parties, globally.
Communicate the company's vision, values, and strategies in a way that builds the understanding and commitment of others.
Facilitate skill development by coaching others and sharing expertise.
Effectively motivate and retain top talent, offer praise, and recognize contributions.
Provide team members with regular and constructive performance feedback, encourage sharing better practices and ideas.
Resolve conflict within the team so that performance and engagement are not impacted.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval)
11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
160 hours annual paid vacation for new hires with manager approval
11 national holidays
3 optional holidays
Unlimited paid sick time
Up to 2 paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day.