Senior Medical Director, Product Safety Physician Lead

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 responsive and collaborative medical review of ICSRs and aggregate safety reviews with cross functional colleagues.

• Accountable for the content of safety sections of the Development Safety Update Report (DSUR), reviews and approves

• Accountable for development and maintenance of RSIs, contributes to the safety sections of the IB, ICF and updates and manages any needs to reconsent subjects in ongoing trials based on emergent safety data assessment

• Actively leads and develops expectations of expected, anticipated statistical analyses to run over trial for the SAP and provides product program wide input on safety statistical elements required for analysis

• Accountable for data requirement recommendations and safety section for clinical data management plan for capture during clinical trials, supports the review and update of data management plan based on updates to integrated safety viewpoint during trial

• Accountable for the determination of safety data required for capture in CRFs during clinical trials, reviews and provides product program wide input to CRFs

• Leads the formulation safety criteria and review of study specific medical monitoring plans

• Participates in investigator meetings, as needed, accountable for product safety profile and reviews, approves and updates of safety presentation content

Developmental Product Safety Monitoring and Surveillance (Protocol Specific)

• Accountable for output/summary report for inclusion into clinical, filing

• Accountable for daily, weekly, and monthly review of SAEs and abnormal labs, protocol specific review of aggregate SAEs and specific analysis of aggregate CTDB (AE tables, shift tables, listings)

Submission Filing Safety Support, as Required for Work on Later Development Programs

• Proactively, reviews and interprets study safety data, supports Clinical Study Report narrative generation, leads the interpretation-based safety sections of reports, reviews draft report

• Accountable for drafting the safety sections of the Summary of Clinical Safety and ISS

• Leads 120-day update plans and activities

Extra-Departmental Liaison & Co-ordination

• Represents and promotes safety at the product development team as core team member, contributes to development strategy for allocated compounds

• Leads the preparations for and attends clinical team meetings

• Actively leads contribution to development of differentiation of BeOne products, provides training guidance to marketing training materials, reviews, and contributes to marketing materials

Internal Global Patient Safety Department Development Interfaces

• Leads GPS product co-ordination, chairs product group meetings across GPS

Pharmacovigilance

• Leads and manages safety PV processes for BeOne and competitor products

• Accountable for the development of Product Safety Strategy and the writing and maintenance of the Safety Surveillance Plans

• Actively leads safety Issue Assessment and documentation, develop determination of issue scope, execute risk assessment

• Accountable for development and update summary of competitor safety profile labelling, FOI, and issues

• Accountable for development and maintenance of product safety profiles and develops Events of Interest

• Presents data at scheduled and ad hoc product safety reviews, chair review meetings, identifies safety issues for escalation to SMT, determine if a safety concern needs escalation to management, facilitates closure on recommendations

• Accountable for development and maintenance of updates to Product Surveillance Plans

• Actively leads the scope, strategy, and content of responses to HA assessment reports, contribute to authoring of relevant sections

• As required for work on later development programs:

  • Actively leads the definition of Risk Management Plan (RMP) drivers & content, reviews core RMP & local RMPs (or REMS) and leads execution of RMP elements, documentation of evidence of RMP execution, evaluates potential risks for evidence of risk confirmation and leads recommendations for RMP/REMS update

  • Actively leads the development of safety Post Approval Commitments (PAC) proposals, facilitates the design of PAC proposed safety study, executes PAC studies

  • Leads and manages the definition of events of interest, defines case follow-up needs

  • Accountable for development and implementation of product launch plans

• Accountable for development of a publication plan, contributes to draft papers

• Contributes to and promotes the development of a global Pharmacoepidemiology (PE) strategy

Compliance, Standards, Training & Project Management:

• Actively leads the evaluation of current processes and assesses alignment with regulatory expectations, guidelines, mandates for regulatory inspections

• Trains and mentors Safety Physicians and Safety Scientists

• Actively leads and maintains an environment of continuous improvement within the team and contributes to continuous improvement initiatives across GPS

Required Qualifications

• MD (or internationally recognized equivalent) plus accredited residency, with 6 + years’ pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development and 4 + years' experience in safety in Phase 1 and Phase 2

• Accredited fellowship with 1-year clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine is preferred.

• Experience in oncology in the preapproval space is preferred

• Prior matrix management team experience

• Prior experience as a product safety physician

• Pharmaceutical product development experience, including individual study design and filing plans.

• Experienced in global regulatory requirements for pharmacovigilance

• Appropriate experience with Regulatory Agency and KOL interactions

Supervisory Responsibilities:

• This position may have safety scientists/physicians reporting to them depending on the program / portfolio being led. The Senior Medical Director serves as Product Safety Physician Lead for multiple or large complex strategically important developmental programs. Works closely with the other Safety Science and Epidemiology Physicians and Safety Scientists as part of a flexible matrix team to conduct robust safety assessments and safety risk management activities, based on ICH standards, for developmental product safety upon which marketed product safety surveillance may be based. The Senior Medical Director is expected to mentor and develop junior staff and offer them support and advice to advance their work.

Computer Skills:

• Intermediate knowledge working with a safety database for retrieval of safety information; Advanced knowledge of MedDRA; MS Office Suite: Advanced application capability with Excel, PowerPoint, and Word. Familiarity with data mining tools and exploratory analyses tools such as Spotfire.

Travel:

• Less than 10%

Education Required:

• MD (or internationally recognized equivalent) plus accredited residency

BeOne Global Competencies:

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork

• Provides and Solicits Honest and Actionable Feedback

• Self-Awareness

• Acts Inclusively

• Demonstrates Initiative

• Entrepreneurial Mindset

• Continuous Learning

• Embraces Change

• Results-Oriented

• Analytical Thinking/Data Analysis

• Financial Excellence

• Communicates with Clarity

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $298,200.00 - $368,200.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .