Global Development Scientist Director
Global Development Scientist Director
Cambridge UK (3 days on site)
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
Come and join our AZ team where you will play a pivotal role in this exciting period of development!
The Global Development Scientist Director plays a vital role in the Clinical Project Team (CPT) and Global Study Team (GST), working closely with other team members, Site Management & Monitoring (SMM), field liaisons, and site staff. Collaborating with the Global Development Medical Director, they focus on clinical aspects of a program, sharing responsibility for planning and driving clinical studies, including recruitment and delivery.
They provide clinical support for late-phase AstraZeneca clinical program strategies, offering input on trial design, execution, data review, results interpretation, and reporting for global product registration. They may also lead process improvement initiatives and cross-project working groups, depending on experience. Strong collaborative communication skills and the ability to influence collaborators are crucial. The role upholds ethical standards and regulatory compliance, and may involve mentoring junior team members.
Key Responsibilities:
Collaborate across clinical product teams (CPT) to transform clinical strategy into study documents (like Global ICF, CRF, TFL shells), establish relationships with consultants, key external experts (KEE), and study sites for protocol feedback, study training, execution, and results interpretation, and ensure the clinical study's scientific accuracy through detailed review and consultation.
Ensure clinical and scientific leadership of protocols and clinical plans, engage with global medical affairs, marketing, commercial, and regulatory teams for cross-functional input, engage in reviews by governance bodies like DRC and PRC, and support health authority interactions as needed.
Provide input to the development of the Medical Oversight Plan (MOP), as well as to study-level safety reviews and medical monitoring activities.
Collaborate with Clinical Operations and CPT/GST members to ensure the timely initiation and delivery of clinical trials, serve as a core GST member representing Clinical Development.
Provide clinical input into Feasibility Questionnaires and consultation on country and site selection, and ensure the clinical and scientific quality of study data.
Ensure timely responses to investigational study sites for local ICF changes, protocol, and EC/IRB queries, engage with advisory boards and site-specific KEEs for robust study designs and recruitment strategies, flag recruitment risks with mitigation proposals and support implementation.
Work with MSLs to partner with SMMs and KEEs for robust feasibility assessments and efficient study execution, and to the development and delivery of investigator and have oversight of training.
Review and interpret clinical data and the preparation of governance committee materials for Go/No-Go decisions, support the development of clinical components for regulatory and EC/IRB submissions for marketing approval.
Assist in creating the clinical study report, collaborate on launch and branding materials and publications, and mentor less experienced staff as appropriate.
Requirements:
Required Life Sciences degree or equivalent
PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience
Industry or academic experience in drug development required.
Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals
Ability to grow and maintain a high level of expertise in oncology therapeutic area
In Office Requirement:
When we put unexpected teams in the same room, we unleash 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 individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca's Oncology R&D business area, you'll be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients' conditions. We're actively embracing and investing in technology, harnessing digital, data and analytics to reimagine the future of healthcare and deliver improved outcomes to patients beyond core medical. We're shaping the future, improving and speeding up portfolio development, improving the patient experience and outcomes at clinical trials. Join the team that is co-creating a digital ecosystem with patients at its core.
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
