Senior Director, Benefit Risk Management Lead, Oncology

Bayer•Tulsa, OK

9d•Remote

About The Position

The Senior Benefit Risk Management (BRM) Lead /Oncology is responsible for leading and close collaborating with product teams of Global Safety Leaders (GSLs) and other PV BRM experts, ensuring patient safety for Bayer’s oncology product portfolio throughout the product lifecycle (pre-clinical to Phase 4 and post-marketing, routine and submission PV activities) and compliance with health authority pharmacovigilance (PV) regulations around the globe through the effective and timely completion of PV assessment activities. This is a senior clinical scientist position with deep expertise in key topics in pharmacovigilance (e.g. drug-induced liver injury (DILI), reproductive toxicity, quantitative signal detection etc.), oncology drug development and clinical medicine, including methods to assess and communicate benefit risk balance, manage and mitigate risk to patients and optimize the safe use of pharma products in clinical practice.

Requirements

MD degree or equivalent (eg, DO or MB);
Significant experience in conducting routine safety surveillance throughout the product life cycle, signal monitoring and detection, development of aggregate safety reports; preparation of submission related documents, including 2.7.4 and 2.5, RMPs, CCDS/labels; safety related regulatory interactions; responses to regulatory queries; assessment of the overall benefit risk profile throughout the product lifecycle;
Strong experience and direct interactions with Major Regulatory agencies;
Ability to interact with expert consultants and Key Opinion Leaders;
Knowledge of relevant concepts in oncology drug development, epidemiology, statistics and evidence-based medicine;
Proven history of effective leadership within a matrix organization;
Experience with the PV toolbox regarding databases/ other IT/Coding systems etc;
Excellent knowledge of pharmacovigilance relevant regulations. Proven evidence of effective delivery of high-quality safety relevant documents
Knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics
Effective Communicator and ability to communicate complex issues in an understandable, effective and relevant manner.
Effectively communicate in written and spoken English.
Strong influencing skills with the ability to explain and defend a position in the face of opposition.
Effective team member. Takes ownership of appropriate issues and appropriately delegates.
Team orientated, recognizing the value of and utilizing diversity.
Strategic focus to activities and planning, with proactive planning and prioritization skills.
Effectively applies processes across assigned team.
Technical expertise in pharmacovigilance and clinical safety.
Excellent analytical and problem-solving skills.
Provide effective and relevant review of complex documents.
Knowledge of relevant legislations and guidelines.

Nice To Haves

Long term experience (~10 y) in the Pharmaceutical, Lifesciences or Healthcare industry with 5 or more years of pharmacovigilance experience with focus on oncology throughout the product lifecycle (pre-clinical to Phase 4 and post-marketing).

Responsibilities

Lead product groups responsible for ongoing BRM and/or leading BRM activities for products of strategic importance by providing in-depth assessment of complex safety and benefit-risk topics based on an in-depth knowledge of oncology clinical development, evidence-based medicine, key pharmacovigilance topics (e.g. DILI), quantitative signal detection and the wide range of ways to assess, communicate and manage the benefit-risk balance;
Responsible for the effective performance for the product/product group of clinical signal detection, evaluation and benefit risk management including:
Monitor and manage the benefit risk profile of assigned product/product group in an ongoing fashion by leading cross functional Safety Management and Benefit-Risk Management teams and implementation of state-of-the art strategies to proactively monitor and assess the benefit-risk balance.
Identify, prioritize and analyze clinical safety signals.
Lead the patient benefit risk management processes through Safety Management Teams
Ensure appropriate clinical safety risk communication and escalation within Bayer Pharma to PV Management and QPPV and committees including SRC, GSC, PET and GLC.
Produce high quality aggregate reports and responses to regulatory queries.
Ensure adequate labeling of safety related information.
Ensure effective due diligence activities;
Work with the Systems and Operations teams to develop and continuously maintain and improve effective systems to ensure single cases (inc PTCs and other relevant reports) are of submission quality and fulfill the requirements for signal detection and aggregate report compilation;
Provide the strategic leadership for the product/product group;
Provide high quality and consistent input to development teams and product teams to support clinical development and life cycle management;
Plan and deploy skilled resources against project priorities;
Contribute to development of budget and work within those allocated constraints throughout the fiscal cycle;
On boarding, training and development within the product/product group;
Maintain an environment of continuous improvement within the team and contribute to continuous improvement initiatives across PV;
Support the strategic goals of PV:
Support the PV Leadership Team in strategic decision making.
Support and lead process improvement and implementation across BPH.
Work collaboratively to ensure consistency of approach across Therapeutic Groups
Maintain effective business relationships to other Bayer Pharma functions to support the implementation of BPH clinical safety standards.