Risk Management Director

Profile

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at

www.astellas.com

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

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.

Essential Job Responsibilities:

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.

Quantitative Dimensions:

Risk management strategies to support development compounds, including during the peri- approval process

Risk management strategies to address new or emerging signals for marketed products

Updates/reports to PV Team, SMT or other governance bodies

Organizational Context:

This position with be located within the Risk Management function of GPV and will report directly to the Head, Risk Management.

Requirements

Qualifications:

Required

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

At least 5-10 years pharmaceutical/health related industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development, with at least 3-4 years of direct experience in risk management (in a global setting 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.

Technical Competencies

Understands and can develop risk management strategy, both in clinical development and in post-marketing setting. Recognized as a credible leader in the area of Risk Management; Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues; Effectively identifies issues that need to be brought to management (also bringing proposed solutions) versus issues to be handled independently. Can work with minimal supervision; Runs effective meetings, including all colleagues' diverse opinions and bringing group to consensus. Next steps and actions are clear; Understands aggregate safety data and signal assessment; thorough understanding of Risk Management internal and external environment, including applicable regulations and guidance

Comprehensive knowledge of drug development process.

Behavioral Competencies

Influences effectively across lines. Develops matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.

Champions high quality deliverables, innovation, and appropriate risk-taking; Ability to understand the sensitivities within the Astellas environment.

Preferred

Key leadership responsibilities in previous role(s) preferred.

Global responsibilities in previous role(s) preferred.

Benefits:

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

401(k) match and annual company contribution

Company paid life insurance

Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

Long Term Incentive Plan for eligible positions

Referral bonus program

#LI-SS

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Type

Full-time

Location

IL, Northbrook

Category

Pharmacovigilance

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/