Senior Medical Director, Product Safety Physician Lead - California, United States - Klein Hersh International

Description

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

Product Labeling:

• 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 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 our client as needed

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

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
• 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

• 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
• Accountable for development and maintenance of updates to Product Surveillance Plans
• Actively leads the scope, strategy, and content of responses to HA assessment reports, contributes to authoring of relevant sections
• 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

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

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.

Travel: Less than 10%

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.

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.