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:
- This position is accountable for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
- This position is accountable to the Clinical Operations Lead and will lead the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution and delivery of assigned trials. This includes vendor selection, implementation and oversight of all trial-related processes and plans in support of protocol execution and mentoring and coaching of clinical staff during execution of development trials.
- Individuals may serve in regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to Health Authorities within their region/country of responsibility. In these cases, they are accountable to the asset team for relevant feedback/input.
- This position may be responsible for managing one or more trials and is accountable for the effective management and oversight of clinical trial budgets, timelines and resources to meet the defined deliverables.
- Represents pre/post-POC Clinical Operations at clinical extended teams or equivalent, portfolio and operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable.
Essential Job Responsibilities:
- Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
- Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities. Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies.
- Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members. Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data.
- Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally.
- Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally.
- Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team. Lead feasibility assessment and selection of countries and sites for trial conduct.
- Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables. Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals.
- Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders. Participates in inspection readiness activities including coordination of clinical study team deliverables.
- Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable.
- Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy. Facilitate and manage regional KOL interactions, as applicable.
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings.
- Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct.
- Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate.
- Performs other duties as assigned or special projects as needed.
Qualifications:
Required:
- BA/BS degree with at least 5 years clinical trial experience or advanced degree preferred (MS/PhD/PharmD) with at least 3 years clinical trial experience.
- Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
- Requires proven project management skills and trial leadership ability.
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Fluent in English.
- Moderate (~25%) travel required.
Benefits:
- Medical, Dental and Vision Insurance.
- Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks.
- 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.
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Category Early Development Clinical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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