Sr. Director - Risk Management & REMS Strategy

United Biosource Corporation•King of Prussia, PA

7d•Remote

About The Position

As leaders in the pharmaceutical support industry, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Requirements

Professional, organized, detail-oriented with a high degree of accuracy, self-motivated and quality driven.
Good leadership and interpersonal skills. Demonstrated ability to inspire effective teamwork and motivate staff.
Excellent oral and written communication and presentation skills.
Good written and verbal communication skills.
Bachelor’s degree in biological sciences or equivalent.
Understanding of FDA-mandated programs.
Relevant scientific and/or epidemiology related experience.
At least 10 years of experience in a pharmaceutical, biotechnology, or clinical research organization.
Experience in protocol writing, study design and operations is helpful, as is familiarity with medical and scientific terminology.
Management of multiple Project Manager level staff

Nice To Haves

Advanced degree in a health-related discipline preferred.

Responsibilities

Serve as a key contact for clients and internal staff for interaction or governance around risk management and REMS Consulting activities.
Provide daily management of the operational and financial activities related to risk management and REMS Consulting.
Provide input into annual plans for Safety and Risk Management services and collaborate with Business Development leadership to support growth of the Safety and Risk Management business.
Evaluate client requests for proposals and support proposal preparation for Safety and Risk Management.
Prepare assigned Safety and Risk Management and other cross-functional team members for client bid defenses.
Support sales process including: ongoing client relationship management, lead efforts to ensure proposal content is in line with client requests and UBC capabilities, coordinating with UBC Executive Leadership for final strategies on opportunities.
Engage as a leader in client interfacing activities, identifying, and participating in conferences and public forum presentations to promote UBC capabilities (including presenting UBC capabilities to potential clients at bid defenses).
Contribute to UBC meetings, training activities and cross-functional activities, as appropriate.
Promote cross selling of broad range of UBC products and services including but not limited to: Evidence Development Solutions, Pharmacovigilance, Patient and Physician Services.
Evaluate and determine appropriate resources to assign to project teams as requested for proposals and project execution.
Ensure project teams prepare project plans to meet contracted services and timelines.
Oversee and manage quality, on–time deliverables related to risk management and REMS Consulting.
Attend, participate and lead (as requested) client discussions.
Assist in the delivery of programs by taking on billable work when appropriate.
Assist in the development of creative and innovative solutions to meet client needs, including the design, implementation, and analysis of epidemiologic studies, registries, large streamlined safety studies, and the development of strategies for REMS and risk management interventions, and evaluation of REMS and risk management programs.
Prepare procedures, SOPs, guidelines and other standard materials required for departmental function.
Track contracts, financial activities, and resourcing utilization to maximize project profitability.
Other duties as assigned.
Supervision and management of assigned staff, including but not limited to, Project Managers, Coordinators and other relevant staff.
Conduct regular 1:1 and team meetings.
Conduct annual employee performance evaluations.