Medical Safety Director MD

Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 8, 2021

Job Description:

Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.

The Portfolio Safety Scientists (PCS-Sci) supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.

The Medical Safety Director is recognized to have strong expertise in drug safety and will be expected to work with minimal oversight and apply strong self-leadership. They will bring safety expertise to interactions with internal stakeholders, Regulatory Authorities and Data Monitoring Committees and must have the ability to interact effectively in a multifunctional and multicultural team setting. The job holder will be expected to identify areas of development and complete the required training.

They may be assigned the role of "Safety Program Strategy Leader (SSL)" for one or more molecules. The SSL is the lead safety accountable for the molecule safety strategy.

Job Responsibilities:

Under the matrix leadership of the SSL and/or in collaboration with PCS colleagues

• Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
• Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
• Provide expert contribution to the development of the product safety strategy
• Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including IB), risk communications, RMP, REMS
• Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
• Take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.)
• Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
• Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
• In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.
• May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
• Perform specialized roles with PSS. These may include, but are not limited to; functional business process owner, subject matter expert, safety committee member.
• Responsible for coordination and collaboration with vendors servicing Safety Science

Additional responsibilities, under the delegated accountability of the SSL

• Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.g., IDCP, CDP)
• Accountable for the safety components of study reports, aggregate reports and high level regulatory documents
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures
• Lead the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective
• Enable/facilitate the transition of appropriate drug candidates from EMS to LMMS

Responsibilities due to medical qualifications

The MSD will provide clinical medical expertise and decision-making, in areas where this is specifically required to support colleagues in PCS. Situations where qualified clinical medical input may typically be sought could include, but are not limited to:

• Acting in a formal capacity as the assigned medically-qualified approver/signatory for any relevant safety-related documents where there may be a regulatory and/or legal requirement for an assessment or approval to be provided by a person who holds formal medical qualifications in a given area of clinical practice, or in a given territory.
• Interpretation of emerging safety-relevant data, in the context of experience gained whilst practicing in relevant areas of clinical medicine/healthcare.
• Defining types of safety question or safety issue, in the context of a molecule/program, that may require specific clinical medical safety assessments or decisions to be made.
• Performing medical practice impact assessments in the context of product quality safety issues (e.g. as part of defined activities outlined in PT-managed processes that require formal assessment by medically qualified individuals).
• Determining the potential clinical medical impact of non-clinical safety findings, and/or the interpretation of potential product risks associated with such findings, in the context of current external clinical practice.
• Providing advice and interpretation of whether/how risks may impact the overall clinical risk-benefit balance of an asset, in the context of typical clinical medical practice in the territories/countries where the product/asset will be used.
• Making formal company medical assessments that may be required from PDS, with regard to the suspected causal relationship between reported events and treatment. For example, where this is required in the context of the management of Individual Case Safety Reports (ICSRs) requiring assessment.
• Review of clinical study development plans and/or study protocols (and other relevant clinical trial documentation), to ensure their design is appropriate to current clinical medical practice. In addition, to ensure that the measures outlined in plans/protocols to manage defined patient risks, are appropriate/feasible to implement in the context of current clinical medical practice, and can reasonably be expected to achieve the clinical risk management aims that have been described in relevant risk management plans.

Behaviours and responsibilities

• Demonstrates behaviors consistent with Roche values and engenders confidence from senior management
• Actively emulate and role model the Roche values, culture (mindset and behavior), Roche core competencies and PD/PDS strategy and drive for similar performance across relevant team
• Understands how safety activities contribute to company development and commercialization goals and takes measures to maximize safety value to the organization
• Demonstrates independence and high competence in the conduct of all safety science responsibilities
• Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
• Consistently comply with all governing laws, regulations, QMS, Roche standard operating procedures (SOPs) and other guidelines
• Develop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements
• Acts independently and with minimal supervision to manage safety responsibilities on study teams and in activities supporting safety science
• Trains and mentors more junior PCS scientists
• Proactively takes on responsibility for complex deliverables
• Takes on team leadership responsibility in order to manage and complete medium and high priority projects
• Seen by peers and cross-functional colleagues as an expert in many safety science activities
• Contributes to embedding the agreed organizational models, and the necessary mindsets.
• Leading self and others, often influencing without authority, to deliver outcomes.
• Brings critical, systematic thinking to shape current issues and opportunities into meaningful, deliverable actions.
• Willing to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.
• Holds themselves and peers accountable for their behaviours and actions

Education, Skills and Experience

Minimum:

They must hold a formal medical qualifications (e.g. MD; MB BS; MB ChB) and have post-graduate experience in one or more areas of clinical medical practice including in medical specialties/disciplines that are relevant to clinical safety and/or to the therapy/disease areas in which the company develops and markets medicines.

Preferred:

They will preferably hold relevant Board Certification(s) or be board eligible, and/or other relevant post-graduate medical qualifications, in relevant areas of clinical medicine.

They will preferably have experience in clinical medical practice and will typically possess 6 or more years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g. academia; CRO; etc). Preferably including at least 3 years of experience in a clinical drug safety-related role.

• The ability to demonstrate a broad understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.g. via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.
• Demonstrated ability to lead and influence, with and without authority, in a global matrix environment.
• Excellent written and verbal communication skills.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
• Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.
• Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
• Ability to effectively train others on departmental practices and processes
• (For roles in China) Fluent in Mandarin and English

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Keywords: Hoffmann-La Roche Ltd, South San Francisco , Medical Safety Director MD, Other , South San Francisco, California