• Job Description

  Req#: R-176804

  Associate Director, SMM Feasibility

  The US BIOPHARMA Feasibility & Recruitment Partner (FRP) is involved with the management of US Site Management and Monitoring (SMM) study feasibility processes, partnering with multiple US SMM staff for the development and implementation of realistic, resource efficient, cost-effective recruitment and retention strategies and plans.

  This role is also a key contributor to the delivery and US patient allocation that is designed to meet regulatory requirements based in understanding of US healthcare environment and site capabilities.

  The individual will actively participates in cross enterprise programs aimed at increasing site performance and successful delivery to US SMM studies.

  Typical Accountabilities

  • Collaborate with US Director of SMM BIOPHARMA Feasibility & Recruitment (US DSSM) to manage, validate and deliver on-time, realistic, resource efficient, and cost effective US feasibility responses. Utilize a culmination of leveraged data, investigator and medical affair insights, and any other relevant information to build robust, sustainable US feasibility targets and strategies.

  • Support all US study delivery models (i.e., globally-led internal studies, early clinical development studies) by collaborating with the US study lead to ensure appropriate US feasibility and recruitment strategies are developed.

  • Contribute to the design remit and study specification validation by identifying US-specific challenges including:

    • Operational feasibility – provide early transparency on recruitment strategies and risks (ie, utilization of recruitment or site identification vendors, site-specific recruitment tools, etc.), define/determine target US site type, share US site type risks and challenges with GST.

    • Protocol design feasibility – identify any conflicts with US clinical standard of care, provide transparency on key delivery challenges, targeted competitive landscape and trends discussions, when available.

  • Identify, follow-up and share in US SMM early pipeline information or project updates to allow early US SMM planning and frontloading US SMM input.

  • Collaborate with local and global study teams to meet study planned LSI milestone, Patient Recruitment Framework recommendations and any other Global Medicines Development patient recruitment objectives.

  • Lead the development of laser focused country-specific and site-specific recruitment and retention strategies that capitalize on feasibility finding to drive study-specific contingency planning, escalation and action implementation plans that ensure local study team/site accountability.

  • Ensure transition of US-specific feasibility knowledge acquisitions by transferring key findings to the US local study team by at the US feasibility transition meeting.

  • Maintains awareness of marketplace activities, policies, trends, technology and information affecting the business and organization to support continued improvement of clinical recruitment efforts adhering to company policies.

  • Champion recruitment and retention practices, process improvement within Clinical Operations and collaborates with internal stakeholders to facilitate the transfer of knowledge and best practices. Support and drive US feasibility, recruitment and retention process improvement and simplification initiatives.

  • Serve as Subject Matter Expert for feasibility and recruitment and participates in training and mentoring of new members of the local study teams ensuring compliance with ICH/GCP and AZ Procedural documents.

  • Capitalize on program/study early engagement opportunities to critically evaluate the delivery needs of the US, serve as an operational voice during early development, share US startup best practices/needed deliverables with GSTs, and distribute key learnings back to the US SMM leadership team.

  Essential

  • Bachelor’s degree in relevant field (e.g. life sciences, business management, or project management) or project management certification

  • 8+ years’ experience in pharmaceutical industry drug development processes

  • Proven experience in managing, influencing, building and maintaining relationships, and achieving results with senior stakeholders in a conflicting priority environment

  • Proven experience in developing and delivering study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives

  • Clinical trial patient and investigator recruitment and retention experience

  • Proven experience in project and budget management

  • Fluent knowledge of spoken and written English.

  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

  • Good knowledge of relevant local regulations.

  • Good medical knowledge in relevant AZ Therapeutic Areas.

  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

  • Ability to travel required, approximately 15%

  Desirable

  • Ability to deliver quality according to the requested standards.

  • Ability to work in an environment of remote collaborators.

  • Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

  • Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

  • Excellent written, verbal, negotiation, collaboration and interpersonal skills.

  • Good analytical and problem-solving skills.

  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

  • Good cultural awareness.

  • Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

  Date Posted

  07-Aug-2023

  Closing Date

  18-Sep-2023

  AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

• About the company

  AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England.

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