Clinical Operations Lead

Clinical Operations Lead

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.

Essential Job Responsibilities:

• Responsible for effective planning, oversight, and execution of Clinical Development Plans and pre/post-POC trials for assigned assets and due diligence projects.
• Ensures expert clinical operations strategy input is provided to Primary Focus Area and/or Asset Teams.
• Develops clinical program budgets and resource estimates for assigned assets and due diligence projects Provides oversight of budget and resources during execution of clinical trials.
• Provides oversight and guidance to extended team members in completing program deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned programs.
• Provide input on clinical operational matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally, as applicable.
• 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.
• Works with teams to proactively identify and manage operational risks that arise during program and trial conduct, including escalation to Primary Operations Lead, functional management, and external vendor management to accelerate mitigation (as appropriate).
• Ensure close collaboration between Early and Late-Stage Clinical Operations Lead(s), including providing strategic and operational input during development and as the assets transition from early to late-stage development Individual can anticipate, recognize, and drive problem solving to rapidly address and mitigate emerging program or trial risks.
• Encourages individuals in investigating and applying clinical best practice methodologies in program(s) and clinical trials.
• Represents Clinical Operations in inspection readiness activities including coordination of trial team quality deliverables Provide oversight and direction to trial team members for evaluation and implementation of patient-focused strategies for assigned trials.
• Participates in resource allocation across the department as required for portfolio delivery and non-drug project initiatives/process improvements.
• Acts as a change champion for Clinical Operations across the global organization.
• Responsible for compliance of direct reports with Astellas policies, procedures, and all associated training.

Qualifications Required:

• BA/BS degree with at least 12 years of executing complex global drug development programs and trials.
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
• Must have strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
• Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
• Must have a strong knowledge of clinical development processes and conducting global clinical programs.
• Must have experience working across multiple phases of development and in multiple therapeutic areas.
• Must have proven leadership skills and effective written and verbal communication skills.
• Fluent in English Moderate (~25%) travel required, depending upon assigned program and phase.

Preferred:

• Direct people management experience.
• Advanced Degree.

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

Category Early Development Clinical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans