Senior Medical Director, Product Safety Physician Lead

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 our client sponsored studies, ensures the safety of patients.

Key Responsibilities

• Accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle
• Actively leads and enhances knowledge of safety profiles for allocated products, including both our client and competitor products
• Identifies and actively leads management of safety concerns for developmental and approved company products
• Actively leads Development and 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

Product Labeling:

• 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

Commercialization Support and Liaison with Other Functions:

• Leads and develops strategic plans for safety differentiation of company products, provides training to 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 our client functions (Legal, Bus Dev, Operations, Marketing, etc.), executes appropriate communication of safety data and interpretation to and external parties, globally, facilitates communication with country office medical directors as required.

Trial Safety Support:

• 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
• 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

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:

• 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 our client 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 our client 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

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.

Key Requirements

• MD (or internationally recognized equivalent) plus accredited residency
• 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.

Other Qualifications:

• 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