Director, Study Start Up-EU

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

​​The Director, Study Start Up is responsible for the leadership of the Study Start Up (SSU) group (SSUAs and SSUA Managers) within the assigned region/s. Responsible for the business strategy aligned to project delivery, performance managing and developing staff, continuously striving for operational excellence and interacting directly with clients in a way that results in repeat business.

Maintains close collaboration with Project Management, Clinical Leadership and Business Development to manage contractual agreements and client expectations. Accountable for leading the SSU team activities including: initial essential document collection, EC/IRB Submissions, site initiation, Ethical Committee submissions (based on location) & close interaction with the site team to work as one team. Works close together with the rest of the management within the department to maintain consistency across the department. Identifies and initiates global process improvements and develop training materials. Creates and develops and manages team to deliver departmental metrics to support business initiatives. The Director works on highly complex and time sensitive issues where analysis of situations or data requires an in-depth knowledge of the organization, process, regulations, and/or project. Proactively identifies, investigates root causes, resolves/mitigates and escalates risks and/or issues.​ 

• Provides immediate oversight for the SSU performance and teams within the assigned region/s.  

• Manages staffing, and resources to ensure departmental utilization within region

• Drives SSU teams to meet project timelines 

• Helps the SSU team to improve about their job knowledge, presentation skills and accountability. 

• Partners with VP to determine, improve, streamline, and apply global efficiencies and processes for SSU 

• Closely collaborates with the SSU mgmt. within the US and in other regions to work towards same goals, objectives in a consistent manner 

• Ensures that the SSU process is proactive and completed according to contractual agreement 

• Exercises principles of risk management 

• Recognizes strategic opportunities to improve department productivity including recommending measures to reduce costs
• Contributes to aspects of business development including evaluating and defining proposal specifications  

• Participates in metric reporting monthly or as required  

• Meets with management staff regularly to ensure that studies are on target to meet contracted timelines  

• Identifies resourcing and staffing of new studies awarded 

• Performs all aspects of managing/mentoring direct reports for training, performance management, and career development   

• Directs and prioritizes multiple assignments in a fast-paced work environment  

• Ensures appropriate transition planning and stakeholder communication for any staff changes  

• Reviews and advises on all applicable SOPs, WGs and ADs related to SSU  

• Acts as a resource for other Managers and seeks opportunities to share knowledge base  

• Produces succinct documentation and presentation for both internal and external use with minimal input from upper management  

Requirements

• ​​Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, scientific or health related field 

• ​7-9 years of related experience (health sciences); clinical trials support or pharmaceutical industry experience preferred 
• Direct experience in study start up roles highly preferred

• ​5-7 years of personnel management, oversight of larger groups preferred. 

• ​Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory drug/device research and development requirements for conducting clinical trials 
• Working knowledge of FDA, European Regulatory and EC procedures as applicable 

• ​Knowledge of site and institution specific contract requirements