Location: Barcelona, Spain (On-site) 3 days working from the office

This is what you will do: 

TheClinical Development Sciences, Director may lead a clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and develop asset-level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for one project, leading the clinical subteam to the GPT and representing clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings and before external audiences. May provide medical oversightto otheryounger, less experienced Clinical Development Scientists.

You will be responsible for: 

Lead or support the clinical sub-team and oversee the design and execution of one or more clinical studies.

Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee). 

Supervise and develop Clinical Development Scientists and/or fellows;

Lead a clinical subteam and prepare a clinical development strategy. May lead one or more clinical study teams in the preparation of clinical study-related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents 

Determine appropriate advisoryboard experts and lead the team in preparation for meetings.

Critically evaluate available information about diseases of interest to the disease area and the competitive landscape and synthesise information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.

Lead the clinical sub-team and study/ies for a given program. Serve as the Medical input to the Global Dev Lead the clinical sub-team and oversee studies within a program. 

Serve as the Medical input to the Global Development Team / Subteam and the Medical Expert clinical study team development Team / Subteam and the Medical Expert for clinical study team.

Liaise internally with other clinical development team members (including ClinDev Scientists and Clinical Project Leads) to drive overall program strategy and development plans. Represent Clinical Development at the Global ProjectTeam.

Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

Support business development activities, such as due diligence and research collaborations

May serve as the Translational Science lead for one or more programs

Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy 

Determine appropriate advisory boards experts

Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management

May supervise other medical monitors on individual studies

You will need to have:

MD or PhD with Clinical Development experience;

>5 years of Development experience, preferably within the industry (a minimum of 3 years of industry experience may be acceptable for outstanding candidates)

Experience as a medical monitor for clinical trials required

Regulatory experience preferred

Publication in peer-reviewed journals

Excellent written / oral communication skills

Attention to detail and ability to think strategically

Willingness to take on new responsibilities

Interest and ability to learn about new therapeutic areas

Interest in career progression and ability to take on more senior roles in 1-3 years 

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. 

We would prefer for you to have:

Advanced knowledge of the assigned therapy area is desired (oncology, pediatrics or neurology), with the capability to interpret, discuss and represent trial or program-level data.

Experience for medical responsibilities on a cross-functional team preferred

Understanding of general (and specific) therapeutic principles

Experience designing and executing industry-sponsored clinical trials

Broad experience in the principles of clinical trial methodology, statistics, data analysis and interpretation

Expertise in scientific literature searches and weighing of quality peer reviewed data

Experience authoring study essential documents, Clinical Study Reports and regulatory documents

Ability to clearly communicate to internal and external stakeholders orally and in writing

Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.

Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget

Ability to think both strategically and tactically

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 authorization and employment eligibility verification requirements.