Study Start-Up Head, Director

Astellas Pharma; Addlestone; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

Astellas Pharma is seeking a Study Start-Up Head, Director responsible for overseeing global study start-up activities. You will ensure execution aligns with clinical strategy, manage cross-functional teams, and uphold quality and compliance while balancing flexibility for hybrid working arrangements.

Qualifications

• Demonstrable expertise in clinical trials and study delivery.
• Strong knowledge of ICH/GCP guidelines.
• Proven track record in regulatory inspections.

Responsibilities

• Oversee global execution of study start-up activities for clinical development.
• Lead the site activation team ensuring compliance and delivery.
• Manage study start-up staff allocations and regulatory documents.

Skills

Leadership

Project Management

Clinical Trials Expertise

Regulatory Compliance

Cross-functional Collaboration

Education

Bachelor’s degree or equivalent

Job description

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About Astellas

At Astellas, experience is coupled energised with a relentless challenger spirit.

Description

Study Start-Up Head, Director

About Astellas

At Astellas, experience is coupled energised with a relentless challenger spirit.

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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.

We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.

We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.

The Opportunity

As the Study Start Up Head (Director), you will oversee and provide strategic direction for the global execution and coordination of study start up activities for all Clinical Development Studies (Early Development & Late Stage) which may include (but not limited too): Contract & Budget Negotiations, Site Activation Management and regional country start-up activities and personnel to support site initiation.

In this role, you will be responsible for supporting the identification and execution of 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 strategy to ensure operational alignment within Medical and Development, along with functions outside of M&D, and across the early and late stage (including MA and RX+, where applicable ) clinical organizations for the relevant support functions. This role reports to the Head, Site Activation & Business Management and forms a part of the Clinical Operations, Development team.

Hybrid Working

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key Responsibilities

• Establishing and leading the global site activation team, ensuring delivery, resourcing, quality, and contractual compliance for all clinical development studies (ED & Late-Stage) across all regions.
• 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.
• 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.
• Acting as a member of the Start-up Leadership Team 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

• Bachelor’s degree or equivalent.
  
  

Additional Information

• This is a permanent, full-time position.
• This position is based in the UK.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
  
  

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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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