Study Start-up 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.

Purpose and Scope:

This position is accountable for the direct management of assigned study start-up related staff across all clinical trial types, 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).  

Accountable for the identification, onboarding, training and development of study start-up talent to support the planning, initiation, and execution of clinical trials with operational excellence.  Individuals in this role will also provide leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.

This position is accountable to the Head, Study Start-up, and will provide input into departmental budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and coaching of staff during execution of development trials. 

This position provides functional leadership and management globally of < 12 direct reports.

Responsibilities and Accountabilities:

• Responsible for resource planning, recruitment, mentoring, development and retention of study start-up staff
• Manages and allocates study start-up resources to trials and monitor performance on assigned trials for staff (up to 12 direct reports)
• Provides direction, leadership and learning opportunities to enhance individual development of direct reports
• Provides oversight and guidance in completing study start-up related activities according to agreed timelines and quality standards, including identifying areas for additional training and development
• Oversees adherence to timelines, standards, processes for work assigned to their staff
• Serves as a point of escalation for study start-up related topics or issues from their staff
• Responsible for compliance of direct reports with training and identification and support for any training needs
• Facilitates and supports global trial study start-up operational standards and tools
• Anticipates, recognizes and facilitates problem solving to support staff and rapidly addresses and mitigates potential performance issues
• Collaborates effectively with Portfolio Operations Leads and Clinical Operations Leads, to ensure study start-up staff are delivering as expected and to ensure common framework and standards across clinical programs and trials
• Ability to collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross-functionally and regionally, including relevant counterparts globally, to align on best practices for study start-up staff
• Identifies, escalates, and facilitates process improvements relevant to study start-up activities
• Contributes to development and implementation of best-in-class study start-up standards and processes
• Responsible for overseeing, developing and aligning resources to ensure effective start-up of clinical trials and a robust talent pool

Qualifications:

Qualifications:

Required

• BA/BS degree with at least 8 years of executing global drug development programs and trials ; Advanced degree preferred
• Minimum of 4 years study start-up activities and direct people management experience
• 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 extensive expertise in study start-up strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
• Must have experience working across multiple phases of development and in multiple therapeutic areas
• 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 proven leadership skills and effective written and verbal communication skills
• Fluent in English. Depending on hiring region, may also be required to be fluent in local language.
• Moderate (~30%) travel required

Salary Range

$145K – $195K (NOTE: Final salary could be more or less, based on experience)

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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Salary : $145,000 - $195,000