Group Director, Late Stage & Marketed Medicines Safety, CVRM

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Roche/Genentech's Product Development organization is organized by therapeutic area and plays a critical role in shaping and executing clinical strategies that bring medically differentiated therapies to patients. Our Global Product Safety team is a dedicated partner to ensure that every Roche product is both effective and safe.

The Group Director, Global Product Safety, Late Stage & Marketed Medicines, CVRM is a leadership position with a high level of responsibilities. The Group Director will lead and direct a global group of Safety Strategy Leaders (SSLs), within their assigned area, to ensure they provide strategic direction and continuous safety-related support for their assigned molecules/medicines.

• You will be accountable for overseeing and guiding the performance of assigned SSLs, to ensure they consistently deliver in line with relevant business strategies, required behaviors, quality requirements, defined processes, and to agreed customer requirements.

• You will be responsible for supporting and shaping safety-related activities and stakeholder interactions that are routinely required at the disease area or franchise levels (i.e. activities that span across multiple molecules/programs, and may involve routinely collaborating with the Clinical Therapeutic Area Head for CVRM, relevant cross-functional leaders within the CVRM Therapeutic Area, CVRM Development Boards and Business Boards and the relevant teams/bodies that operate and make decisions at that level).

• You will collaborate with colleagues/cross functional leaders, to ensure delivery performance oversight and quality of outputs; seeking to address any issues holistically so that their shared customers receive a seamless service.

• You will ensure the leadership team remains informed of their team's delivery priorities, performance and they share information on relevant safety topics/issues, as appropriate.

• You will coordinate the transition of knowledge for those molecule assets that are transitioning through the various phases of development: Ensuring a robust and independent safety position is established/maintained/shared for the assets supported across their respective teams.

• You will support the assigned team to build relationships and grow their influence with relevant stakeholders to ensure scientific delivery impact, and the delivery of all required safety outputs is achieved in line with the organizational priorities/plans and to agreed customer requirements.

• You will act as an expert reviewer for relevant safety-related documents that have been prepared by the relevant SSLs and supporting teams (e.g. safety strategies and plans; safety content of protocols; DSRs; clinical study reports; Investigator's Brochure (IB); ; relevant safety communications; and safety-related scientific publications), as appropriate; You will collaborate and partner with PCS GD's and TL's to ensure co-development, implementation and monitoring of the effectiveness of risk assessment or risk mitigation approaches (e.g. guided safety questionnaires) and the overall execution of molecule/product-related safety support.

• You may be required to represent your team or functional perspective at relevant governance or decision bodies (e.g. GVP Council, DSC, Development Board, TA Advisory Meetings) and/or participate on relevant cross-functional programs (e.g. Safety Strategy teams; PD Leader meetings & TA initiatives that could impact the portfolio/safety function); You may be required to represent Roche Product Safety at external meetings with regulatory authorities and third parties such as potential licensing or co-development partners, etc.

• You will be leading a global team of scientists and healthcare professionals performing SSL roles; You may be required to coach and support members of your teams when they are assigned to perform these types of activities.

• You will be responsible for building strong partnerships across the Product Development Organization; Collaborating with internal Roche stakeholders to ensure that they, and their assigned team, are delivering upon relevant molecule, disease and portfolio level strategies and shared priorities across the wider Roche organization; you will seek feedback from across the respective customer groups (e.g. Clinical Development, Medical Affairs, Affiliates, EU QPPV, etc) to ensure that the influence and impact of their teams and their scientific deliverables are continually adding value and are supporting the delivery of the Roche Product Safety strategy and value propositions.

This position is based onsite in Boston, Massachusetts, USA.
Relocation benefits are not being offered for this position.

Who You Are:
(Required)

• You have a MD, MBBS, PharmD and/or PhD within the Life Sciences space.

• You have 10+ years of industry experience (clinical development/safety/pharmacovigilance) with 6+ years of safety-related experience in clinical drug development.

• You have a demonstrated understanding of both pre- and post-approval drug development, and bring a broad knowledge of the scientific aspects of safety, PV and clinical/patient risk management (e.g., via demonstrable understanding of the application of GVP, GCP & CTR requirements) are essential.

• You have the proven ability to understand, manage and routinely take decisions concerning safety issues, often in situations of ambiguity. Ideally, candidates will have experience in leading or participating in safety, benefit-risk, issue management and clinical risk management activities in a bio-pharmaceutical or healthcare organization.

• You have demonstrated leadership skills.

• You have demonstrated technical and strategic thinking, combined with the ability to devise, communicate and implement strategies at a product, matrix or organizational level.

• You can prioritize multiple tasks and goals on time, on target, and within budget.

Preferred:

• You have previous experience of operating as a senior level global safety leader

• You have strong technical and strategic thinking, combined with the ability to devise, communicate and implement strategies at a product, matrix or organizational level would be an advantage

• You have an understanding of the key factors involved in supporting talent and skills development (e.g. provision of effective coaching and talent development approaches for experienced professionals) would be highly advantageous.

• You have proven success in creating and sustaining strong relationships with internal partners across an organization, to foster positive partnerships. You have strong influencing, negotiation and conflict management skills; the ability to influence with and without authority.

• You have demonstrated competence when interacting with others at all levels, both internally and externally. You have demonstrated courage and conviction in past positions and responsibilities. You have demonstrated leadership through authenticity, transparency, self-awareness, and empathy consistent with Roche's Operating Principles.

• You have impeccable ethics and are able to align to Roche values.

The expected salary range for this position based on the primary location of Boston, MA is $203,000 - $522,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.
Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.