Algemene informatie

Job Advert Title
Risk Management Director
Locatie
Nederland
Function/Business Area
Legal, Risk, Ethics & Compliance
Afdeling
Risk Management
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Risk Management Director

About Astellas:

At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

About this job:

The Risk Management Director is responsible for the development of risk management activities and strategic planning and is a member of the GD Product sub- teams. It is the responsibility of the Risk Management Director to delineate (define, plan) risk management strategies that are aimed at achieving optimum benefit-risk for products throughout the lifecycle of the drug. The individual will use strong leadership, communication, and risk management expertise to successfully advise resources and ensure effective collaboration across GPV functions and sites. The Risk Management Director will partner with Medical Safety, Epidemiology and other GPV functions to optimize the ability for teams to provide RM deliverables in the agreed upon timeframe. In addition to working with GPV stakeholders, the Risk Management Director will partner with the Medical Sciences, Statistics, Regulatory, Legal, Pre-Clinical disciplines, European Safety Office and other key stakeholders to effectively plan risk management strategies that enhance Therapeutic Area Strategy and project-product life-cycle management.

Key Activities are noted below:

  • Leads the development of policy for project/product risk management strategy (D-Risk Management Plan) and internal and regulatory action plans for real and theoretical safety risks in partnership with the project/product team, and advises product teams to ensure clear and balanced communication to senior management.
  • Advises product teams in a manner to optimize the implementation of risk management strategies for specific risk assessment activities and documents, coordinating and/or authoring documents as appropriate, providing project teams/senior management with a comprehensive recommendation on risk management strategy.
  • Organizes and provides administrative support to the appropriate governance committees by ensuring that routine updates are provided.
  • Advises product teams for development of Investigator Brochure activities where appropriate (i.e. “Advice to Investigators” Section).
  • Oversees the policy that is developed for teams that will be responsible for authoring, updating, and maintains the Risk Management Plan (RMP, EU-RMP, REMS), ensuring compliance with current local regulatory requirements. The RML advises teams to ensure that post marketing risk management activities are aligned with the Risk Management Plan.
  • Advises teams to lead development of peri- and post-approval safety commitments during the endgame and approval phases, and may assist in negotiating these commitments with regulators; coordinates post-approval safety commitments.
  • Assists teams with communication and knowledge transfer across project/product teams, Therapeutic Areas, and GPV regarding risk management positions, policies and strategies.
  • Creates and fosters an environment of partnership and collaboration between GPV and the project/product team. Develops and sustains constructive relationships with preclinical disciplines, Medical Affairs and other APGD teams.
  • Supports the Global RM Head with designing the risk management function Global PV, timely implementation, and evaluation of the function.
  • Advises teams to ensure risk management awareness and communication at investigator meetings, as appropriate.

Experience and Knowledge:

  • Extensive experience in pharmaceutical/health related industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development, with at least some years of direct experience in risk management (in a global setting preferred).
  • Key leadership responsibilities in previous role(s) preferred.
  • Global responsibilities in previous role(s) preferred.
  • Strategic thinking, Organizational, Leadership. Results-oriented performance. Team player.
  • Excellent knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required).
  • Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
  • Proven ability to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist.

Qualifications:

  • Advanced health related sciences degree (PhD/PharmD) or MD; or equivalent.

Additional information:

  • Currently this position has the flexibility to work from home and in the office.
  • This is a permanent full-time position based in the UK or in the Netherlands, or in US or in Japan.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.