Associate Group Director - Portfolio Safety Science (PSS)

19 Jul 2019
13 Aug 2019
Full Time
Experienced (non-manager)
Associate Group Director - Portfolio Safety Science (PSS)


The PSS Associate Group Director will provide line-leadership for a team of scientists, physicians and/or other health professionals, of varying levels of experience and seniority, who operate in support of complex scientific safety and pharmacovigilance (PV) activities across all Roche assets throughout the lifecycle. Reporting to a PSS Group Leader, typically the PSS Associate Group Director will manage teams based within a geographic region, although the assets and stakeholders they support are global. 

In this role you will...

  • Bring personal relevant expertise to the scientific, clinical, pharmacovigilance and/or business-related activities of the PSS function; identifying and working with wider  scientific safety experts and stakeholders by taking accountability for ensuring that their PSS team delivers effectively in the seamless provision of scientific and PV outputs/deliverables for its Roche customers
  • Ensure oversight of team performance in terms of delivery quality, collaborating successfully to maintain appropriate training and skills including support for the adoption of new techniques and agile approaches; support the ongoing production of relevant KPIs, as required
  • Provide excellent line-leadership and be responsible for managing and planning the team's resources; recruiting and developing scientists and HCPs at all levels within the function; motivate the team and ensure the appropriate balance of expertise and skills are available to meet the current and future demands; role-model Roche Values and Leadership Commitments and any changes in behaviour and mindset that are necessary for the function to succeed within the business delivery models across PD and Roche
  • Bring critical thinking to shape current issues and opportunities into meaningful, deliverable actions by anticipating potential issues, risks and opportunities; all by continually focusing on implementing process improvements and adapting the team's ways of working in order to achieve quality and efficiency improvements
  • Have responsibility for overseeing the delivery of PV, safety & risk management deliverables following defined, quality bound processes, via their team of HCP/scientists. The deliverables may include (but are not limited to) clinical trial safety support, patient risk management, safety signal management, safety regulatory reporting. The TL may also need to coordinate team member contributions that are delivered  in support of molecule safety strategies and related activities (e.g. Filing-related activities; query responses, etc). 
  • Take accountability for any delegated responsibility for the review and/or approval of specific safety science and/or PV deliverables, in line with agreed delivery models and/or defined process responsibilities
  • In coordination with delivery SMEs, and PSS Alliance Management roles, be responsible for implementing effective service provider mechanisms, to enable oversight of routine PV deliverables
  • Lead and engage with PDS strategic projects, contribute to defining and implementing the PSS vision, priorities, and strategy; take responsibility for building strong partnerships within PSS, with scientific safety colleagues (i.e. across EDS, LMMS and PVSD), with other PDS functions (e.g. IPV, BMO, PDSO), and other key stakeholders (e.g. GPOs, Scientific Enablement Leaders, IPV Liaison, etc)
  • Adhere to process delivery requirements in that all relevant Health Authority expectations and related Roche quality requirements are met, across all relevant areas of process execution and molecule/product support
  • Be responsible for ensuring the team's ways of working and deliverables are in continual compliance with relevant GxP requirements, and relevant Roche processes and standards and teams are prepared to contribute to audits and inspections in their capacity as scientific and PV delivery experts
  • Identify and manage team members' performance and development through proactive planning, effective recruitment and building strong relationships with partners in EDS and LMMS (e.g. line managers, Safety Program Strategy Leaders (SSLs)); identify and manage resource needs at SSL level, working under overall guidance from the PSS Leadership Team
  • Ensure team members are following the PSS learning and development program so as to equip team members with the required pharmacovigilance, scientific, leadership, communication and additional interpersonal skills to provide the required resources and contribute to knowledge sharing and proactive planning of resource needs across PSS at all levels
  • Proactively manage a "high performance team culture"; drive consistency and continuous improvement across the assigned team; conduct ongoing dialogue as part of the performance management cycle, performance calibration, talent management and succession planning; compliance with employment laws, regulations and company HR policies and procedures; ensuring staff communication and employee relations are managed proactively within the site to maximize the wellbeing of the employees

Who you are…

  • A qualified healthcare professional or Life Sciences graduate. You will preferably be medically qualified, or hold a relevant postgraduate scientific qualification (e.g. PharmD, PhD or MSc; and /or have relevant business management qualifications)
  • It is essential to demonstrate an understanding of relevant scientific aspects of safety, PV and/or clinical/patient risk management (e.g. via demonstrable knowledge of international drug regulation and the application of GVP, GCP & CTR requirements)
  • Experienced in operating within a clinical pharmaceutical development environment, and/or clinical/healthcare practice is preferred. You will typically possess more than 5 years of experience within a biopharmaceutical or clinical research organization, bring a broad understanding of the whole drug development process/lifecycle, and are likely to have direct experience of delivering safety-related activities in support of clinical drug development and/or pharmacovigilance
  • Demonstrable people and project/change leadership and influencing skills are key (e.g. via prior line- or matrix- leadership roles), including the ability to provide effective coaching to individuals and teams through a combination of listening, curiosity, intuition, self-management and action and the experience of proactively driving a variety of tasks and projects and delegating to a team.
  • Excellent written and verbal communication skills with strong negotiation and conflict management skills
  • Proven success in creating and sustaining strong relationships with internal business partners across the organization and creating positive partnerships with external bodies


Travel Requirements:
  • Ability to travel globally is expected


Roche is an equal opportunity employer.
Research & Development, Research & Development > Drug Safety