Director, Study Start-up R&i

**Director, Study Start-Up R&I**

**Locations: Mississauga, CA; Warsaw, PL; Gothenburg, SE or Barcelona, ES**

**Competitive salary and benefits**

**Bring out the best in each other, and yourself, by working together as one**

In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace.

Be appreciated for your contributions. Our culture of recognition and reward means each of us feels supported and empowered to step up and take ownership. With all the tools you need to excel at every level, coupled with ongoing constructive feedback and coaching, there’s no better place to bring out your best.

The **Director, Study Start-up Management** (DSS) is an important role within Study Management, Biopharmaceuticals, whose main accountability is leading and planning operational deliverables of the start-up group across programs. The DSS provides input to early study planning activities based on operational expertise and collaborates with Global Study Associate Directors (GSADs), Senior Global Directors (sDSMs), Directors Study Management (DSMs) and other internal team members cross-functionally, and / or external partners, to identify, lead and resolve issues affecting study start-up delivery.

Accountable for resourcing, leading, developing, supporting, and providing direction to Study Management Start-up (SM) personnel to enable successful study start-up delivery.

You will also be responsible for embedding consistent ways of working in start-ups across locations and building Study Management capabilities in start-up space.

The DSS ensures that direct reports are equipped with the right skills and capabilities to successfully lead and deliver clinical trials in the start-up phase. Takes ownership and acts as a change agent to drive consistent implementation of globally agreed Development Operations strategies including processes and technology, related to the delivery of studies in the start-up phase.

**What you’ll do**
- Work within the Study Management Leadership Team to achieve accurate start-up resource forecasting and develop solutions to efficiently and flexibly resource study start-up teams
- Develop start-up team RACI and key performance indicators (KPIs quality and operational)
- Supervise transition process from start-up to maintenance study team
- Collaborate with other functions to establish strategies and identify commonalities aimed at increasing efficiency in start-up phase of global study teams (core and extended)
- Lead non-drug project work such as SM representative in process improvements and / or improvement projects impacting start-up delivery as discussed and agreed upon with their manager
- Participate in setting, and be responsible for implementing, the vision & strategy for the Study Management, aligned with Development Operations Vision & Strategy
- Lead and support change by encouraging diversity of solutions and implementing process changes consistently across Study Management
- Ensure quality and compliance to External Regulations and AZ Standards
- Provide authority input into functional and cross-functional global processes
- Develop the sharing of study delivery knowledge, information, and standard methodology
- Line management of Study Management Start-up staff
- Ensure personnel have been trained and work within compliance of ethics, company policies and standard procedures
- Be a role model and embed a performance driven culture and coach staff for optimum performance
- Develop and cultivate capabilities of our present and future AZ leaders
- Lead performance including feedback and rewards
- Provide expertise and direction to support direct reports with proactive problem / risk identification, solution building and issue resolution to facilitate achievement of objectives on time and to appropriate quality.

**Essential Criteria**
- University degree (or equivalent), preferably in medical or biological sciences or team associated with clinical research
- At least 7 years of clinical trial experience
- At least 3, with preferred 5 years expertise in global study leadership and team leadership of experience
- Demonstrated study management expertise/abilities in start-up phase e.g.: in leading large phase 3 pivotal and studies with a high degree of complexity, or multiple smaller studies simultaneously.
- Validated project management experience on a global level (APM or similar training)
- Shown leadership and ability to promote motivation and empower others in order to accomplish individual, team and organizational objectives
- Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and abilities in clinical study management processes and clinical/drug development
- Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, patient safety, and regulatory a