Global Development Scientist Director

Global Development Scientist Director

Cambridge UK (3 days on site)

About AstraZeneca

AstraZeneca is a global scienceled patientfocused biopharmaceutical company that focuses on the discovery development and commercialisation of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds 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 latephase 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 crossproject 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 studys 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 crossfunctional 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 studylevel 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 sitespecific 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/NoGo 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 lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 AstraZenecas Oncology R&D business area youll be part of a team playing a critical role in driving meaningful change in the way we predict prevent and treat patients conditions. Were 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. Were shaping the future improving and speeding up portfolio development improving the patient experience and outcomes at clinical trials. Join the team that is cocreating 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.

Date Posted

Closing Date