Senior Director, Study Start Up Head
2 weeks ago
Senior Director, Study Start Up Head
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
As the Study Start Up Head (Senior Director) you will establish and lead the global study start-up department, ensuring delivery, resourcing, quality, and contractual compliance for all clinical development studies (ED & Late-Stage) across all regions.
In this role you will provide strong leadership and management to the study start-up team, addressing escalated / recurrent issues, finding resolutions, and continuously improving operational efficiencies of study start up activities. You will oversee and provide strategic direction for the global execution of study start up activities for all Clinical Development Studies (Early Development & Late Stage) which may include Site & Country Feasibility, Contract & Budget Negotiations, Site Payments, Regulatory Document Collection to support site initiation, ICF, site qualification & initiation visit coordination, and IRB / EC submissions.
This role reports to the Executive Vice President, Head of Clinical Operations, Data Sciences and China Development.
Responsibilities:
- Acting as the primary decision-maker for portfolio study start-up issues, collaborating with cross-functional teams to resolve problems at the study level. Monitoring portfolio performance against site activation timelines and metrics (e.g., as defined by corporate objectives), while adhering to budget targets
- Managing allocations of study start-up staff which includes regulatory document collection and site contracts/budgets, and frequently update resource algorithms based on portfolio needs
- Supporting identification of and executing interventional trial support strategies aimed at increasing productivity and quality while decreasing cycle times and cost and for the development and implementation of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development, along with other functions and across the early and late stage clinical organisations for the relevant support functions.
- Acting as a member of the Extended Clinical Operations Leadership Team (COLT) and providing input into sub-division structure, budget and resourcing strategies, including development and implementation/oversight of processes & procedures, training, coaching and mentoring of staff.
Essential Knowledge & Experience:
- Demonstrable expertise in clinical trials including extensive leadership experience of global study start-up activities and study delivery.
- Recognised leader in functional management and direct people management
- Proven track record of experience in working with teams to prepare for regulatory inspections including inspections readiness, participating in regulatory inspections and preparing responses to inspection findings.
- Strong knowledge of current regulations, trends and practices in areas of support function responsibility
- Must have demonstrated extensive expertise in developing global clinical development strategies along with strong knowledge of ICH/GCP guidelines including multinational clinical trial guidelines
Preferred Experience:
- Represented or participated as a member of governance committees both with vendors and external collaboration,
- Partnered with cross-functional leaders on initiatives, activities and deliverables that span across Clinical Operations
- Experienced in managing international employees.
- Management experience in multiple clinical operations positions
- Clinical trial management leadership
Education/Qualifications:
- Bachelor’s degree or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in EU or US.
- This position is 100% home/remote based.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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