Director Study Leader

3 weeks ago

Santa Monica, United States AstraZeneca Full time

Are you ready to take the helm of a dynamic team dedicated to pioneering new frontiers in Oncology? As the Director Study Leader, Cell Therapy, you will be responsible for delivering a single or several smaller Cell Therapy development programs. You will lead multiple Cell Therapy studies or single complex/novel studies such as platform, basket, etc. This role requires a high degree of flexibility and autonomy. You may also provide expert input to other non-drug programs and process improvement projects.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. Join us in our Santa Monica, CA location. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

**Accountabilities**:
Your role will encompass a wide range of responsibilities. You will provide expert clinical operational input into project or study level documents and may lead the delivery of study documents. With oversight from the Clinical Program Director, Cell Therapy, you may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions. You will lead the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards. You will also lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative.

**Essential Skills/Experience**:

- University degree/Bachelor’s degree in related discipline, preferably in medical or biological science.
- 10 years drug development experience demonstrated in a variety of roles
- 5 years of experience in leading studies/programs in clinical development
- Comprehensive knowledge of the clinical drug development process
- Extensive and proven experience in driving operational delivery to timelines, cost and quality
- Proven experience leading delivery through internal and external organizations.
- Excellent knowledge of ICH-GCP principles
- Project Management experience within the context of Clinical Drug Development
- Experience and strength in working and leading in matrix teams
- Strong collaborative communications skills including the ability to engage with diverse stakeholders
- Proven ability in problem solving and issues management that is solution-focused
- Ability to lead strategic and/or operational management of individual clinical trials
- Experience in selection and oversight of external providers and development/review/providing clear requirements of contracts

**Desirable Skills/Experience**:

- Higher degree e.g. PhD, MSc, MPhil
- Program management qualification (e.g. MBA, PRINCE2, PMP)
- Experience in variety of academic/CRO/Sponsor organisations and countries
- Experience of early phase clinical delivery
- Experience in autologous or allogeneic therapies in oncology

Why AstraZeneca?

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. A place built on courage, curiosity and collaboration, we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

Pay Transparency: The annual base salary for this position ranges from $154,724 to $212,746. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary paymen

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