Associate Director/Director Study Leader, Cell Therapy

Do you have expertise in Oncology, and a passion for cell therapy? As an Associate Director (AD)/Director (D) Study Leader Cell Therapy, Clinical Operations, you will deliver a single or several smaller Cell Therapy development programs. Join us to apply your expertise to impact the lives of patients living with cancer, follow the science, and turn ideas into life-changing medicines.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. 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.
Summary of Group: Pioneers of collaborative research, we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world's foremost medical centers. Working seamlessly and inclusively together, we expedite research in some of the hardest-to-treat cancers. Do you want an opportunity to build a rewarding and meaningful career as part of a team committed to improving the lives of millions with cancer?
Director Study Leader Responsibilities: Clinical Operations delivery of a single or several smaller development programs or leading multiple studies or single sophisticated/novel studies. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility and autonomy is required. May also provide authoritative input to other non-drug programs and improvement projects. Provides authoritative clinical operational input into project or study level documents, for example, clinical development plan, clinical study protocol, clinical study report, and may own the delivery of study documents May lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions Owns 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 Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate Ensure sponsor oversight throughout the life of the study Develops and leads effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and advance issues to partners as appropriate Responsible for planning and leading issue customer concern and resolution Provide input to forecasting and management of study/program delivery costs, resource and timelines Accountable for the quality of study/program planning information into relevant planning systems Mentors and supports the development of individuals within the organization Contributes to operational interactions with external entities, including regulatory agencies, preferred partners/suppliers, and external collaborators Responsible for oversight of CROs and other clinically outsourced third-party vendors for outsourced studies and programs Responsible for study-level reporting of progress, risks, and issues Lead the study delivery-related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance Provide procurement clear specifications for study or program-specific outsourcing Review and operational approval of study or program-specific contracts or work orders ?Education & Experience: Bachelor's degree in related subject area, preferably in medical or biological science. Associate Director Level - 7+ years of drug development experience from within the pharmaceutical or biotech industries Director Level - 10+ years of drug development experience from within the pharmaceutical or biotech industries Required Skills: Clinical Operations and Cell Therapy or Gene Therapy experience Extensive and shown experience in driving operational delivery to timelines, cost and quality Shown experience leading delivery through internal and external organizations. Excellent knowledge of ICH-GCP principles Experience and strength in working and leading in matrix teams Strong collaborative communications skills including the ability to engage with a diverse client base and lead through conflict Proven track record in problem solving and issues management that is solution focused Ability to lead strategic and/or operational management of individual clinical trials Experience in providing clear requirements for external contracts Experience in selection of external providers and development/review of contracts Confirmed oversight of external providers Desirable Skills: Advanced degree e.g. PhD, MSc, MPhil Program management qualification (e.g. MBA, PRINCE2, PMP) within the context of Clinical Drug Development Experience in a variety of academic/CRO/Sponsor organizations and countries Experience of early-phase clinical delivery When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. 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. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $154,000 t0 $232,000 for Director Level. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
NeoGene Therapeutics is a clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). Neogene operates as a wholly owned subsidiary of AstraZeneca, with operations in Amsterdam, The Netherlands and California, US. Why AstraZeneca? At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next? Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
If you're curious to know more then please get in touch. We would welcome your application, and look forward to speaking with you soon.
The successful candidate will have access to a comprehensive benefits program, including paid time off, 401K contributions, performance development, performance recognition scheme and a competitive, generous remuneration package.
Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Date Posted
01-Oct-2024 Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.