South San Francisco, California
Medical Safety Director, Safety Strategy Leader
As the Safety Strategy Leader (SSL) you are responsible for the safety profile and patient risk management strategy for your assigned product/molecule/program(s) (hereafter referred to as program(s)). While deployed to perform the role, you are empowered to work independently under the oversight of a relevant Group Leader in Early Development Safety (EDS). You also provide program-specific scientific direction and guidance regarding the implementation of the safety profile for a matrix team/network of safety scientists who are typically assigned to support the program from Portfolio Clinical Science (PCS). You play the leading role in defining long-term safety-related objectives for your program(s), acting as the lead point of contact for safety for wider cross-functional leaders; being responsible for the high-level safety program design/plan; guiding the scientific approach to the acquisition, monitoring, analysis/evaluation and communication/reporting of program-specific safety information. You will articulate the overall design and the requirements of their defined safety strategy, in the context of the wider development program (e.g. the TPP, CDP) and/or the medical value narrative. You are accountable for ensuring that program-specific safety communications and patient risk management approaches are implemented and can be demonstrated to be effective in achieving their defined aims. As SSL you are centrally involved in safety-related and benefit-risk decision-making activities for your program(s). You will effectively engage and influence multiple cross-functional partners in order to act as the key safety point of contact. Your role is therefore considered to be pivotal to the overall success of the program(s) you are assigned to.
Responsibilities due to medical qualifications. The MSD will provide clinical medical expertise and decision-making, in areas where this is specifically required. Situations where qualified clinical medical input may typically be sought could include, but are not limited to:
● Acting 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 while 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, 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.
Behaviors and responsibilities:
● Demonstrates behaviors consistent with Roche values and engenders confidence from senior management
● Actively emulates and role models 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
● Develops and maintain sknowledge 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 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 safety science activities
● Contributes to embedding the agreed organizational models, and the necessary mindset
● Leads self and others, often influencing without authority, to deliver outcomes.
● Brings critical, systematic thinking to shape current issues and opportunities into meaningful, deliverable actions.
● Challenges 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 behaviors and actions
Education, Skills and Experience
● Hold a formal medical qualification (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.
● Hold relevant Board Certification(s) or be board eligible, and/or other relevant post-graduate medical qualifications, in relevant areas of clinical medicine.
● 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.
● 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
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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