Senior Medical Director, Product Safety Physician Lead

About this role

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
The Senior Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often multi-indication) and creates and maintains a single interpretation of global safety data for developmental. With the support of Safety Physicians and Safety Scientists identifies and manages the documentation and communication of safety concerns and together with teams engaged in BeOne sponsored studies, ensures the safety of patients.
Essential Functions of the Job:

• Accountable for oversight of benefit/risk safety profile of allocated products through the product life cycle with a principle focus on early development

• Actively leads and enhances knowledge of safety profiles for allocated products, including both BeOne and competitor products

• Identifies and actively leads management of safety concerns for developmental and approved BeOne products

• Actively leads Development and, as required, Medical Affairs product teams in the identification of, and handling of product safety concerns

• Governance:

• Chairs Safety Management Team (SMT) meetings for assigned products, reviews SMT materials, develops & represents safety perspective in SMT meetings

• Represents the SMT and participates in Company Safety Committee (CSC) meetings, support meeting preparations, develop & proposes review topics/ CSC agenda items

• Actively leads communication of recommendations to labeling group/other stakeholders

• Actively participates in meetings as required in External Safety Monitoring Committees (DMC) meetings through provision and review of safety data, insights and leadership and provides input to DMC Charters

• Actively leads Internal Safety Monitoring Committees (SMC) meetings (e.g., dose escalation safety meeting) & supports as needed. Provides input to safety charters

Product Labeling, as Required for Work on Later Development Programs

• Actively leads communication of CSC recommendations for labeling amendments, participates in Labeling Working Group meetings, leads communication of Safety outcomes to relevant stakeholders

• Actively leads the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and manages approval of amendments

• Presents the CCSI to the labeling committee, contributes viewpoint to CCDS development, and reviews company core data sheet

• Provides safety insights to development of Package Insert and Labeling Updates, develops labeling update impact summaries for use by RA, develops labeling prose text updates, based on internal aggregated reports

Issues Management

• Leads and manages escalation of potential issues to the SMT, ensures internal notification and provides updates

• Leads and develops strategy for issue management and facilitates internal approval of plans

• Leads the review of issue data and closure on recommendations, leads the drafting of an issue response document, reviews, and manages approval of issue response documentation and responses

• Leads the formulation of a rapid response procedure, triage of potential issues to safety committee, executes Crisis Management response plan, reviews ongoing issue and plan

• Reviews regulatory inquiry to lead strategizing the nature of response, best course of action and determines data specifications, Reviews relevant data required for response

• Leads responses and contributes to formal response provided to regulatory agencies, reviews draft response, and manages approval of response

• Actively leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis

• Actively leads BeOne safety in face-to-face regulatory meetings

• Actively leads and develops an evaluation of safety enquiries (Internal, External, HCP & consumer), leads the assignment of response drafting responsibility, determines data required for response, reviews response data & drafts response and manages approval of responses

• Guides and leads medical review of SAEs and provides immediate input to escalated reports, determines, and executes further escalation within BeOne as needed

Commercialization Support and Liaison with Other Functions

• Leads and develops strategic plans for safety differentiation of BeOne products, provides training BeOne employees on product safety profiles/issues, provides input into commercial publications strategy, reviews publications, including abstracts, manuscripts, and speaker presentations, provides input for potential in-licensing opportunities as requested

• Leads product liaison for BeOne functions (Legal, Bus Dev, Operations, Marketing, etc.), executes appropriate communication of safety data and interpretation to BeOne and external parties, globally, facilitates communication with country office medical directors as required.

• Leads EU/International Safety Communication & Co-ordination training to BeOne employees on product safety issues and profiles

Trial Safety Support

• Accountable for the collaborative authoring of safety content in clinical trial documentation, including but not limited to protocols, IBs, and ICFs. Able to collaborate and advise on technical aspects of trial design including escalation and expansion design, DLT criteria, inclusion and exclusion criteria, and risk monitoring and management aspects.

• Accountable for safety data, reviews and provides advice on Safety Endpoints, safety related inclusion and exclusion criteria data to capture during trial, key review activities and timing, reviews and leads input on product program wide safety issues, protocols, and protocol updates. Expected to demonstrate and model…