Senior Director, Global Clinical Development- Vaccines And Immune Therapies

Opportunity: Global Clinical Program Lead (GCPL) - Vaccines and Immune Therapies- mAb
Locations: USA, Gaithersburg, Sweden, Gothenburg, UK, Cambridge
Salary: Competitive, with excellent benefits
Do you have expertise in, and passion for, Global Clinical Programs? Would you like to apply your expertise to impact the Clinical Program in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we are not afraid to do things differently. We are resetting expectations of what a bio-pharmaceutical company can be. The Vaccines and Immune Therapies unit has been created to optimize AstraZeneca's portfolio of Vaccines and antibodies for infectious diseases. The creation of this unit reflects AstraZeneca's strong commitment and focus on this area, developing and implementing scientific advancements, while positively impacting the lives of patients worldwide.
What you'll do:
As a Global Clinical Program Lead, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. The Biopharmaceuticals Research & Development, Late-stage Development, Vaccines and Immune (V&I) function drives late-stage development of our innovative pipeline, including RSV, influenza & COVID-19, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
We are looking for a highly qualified candidate to lead the Clinical Development and execution of the product strategy for multiple projects. This individual will be accountable for the strategic Clinical Development plan and clinical execution of the compounds and reports to the Global Clinical Head (GCH) of the disease indication. The individual will articulate the project goals, strategy and the underlying science and clinical need to internal and external audiences with clarity and credibility. The individual will be responsible for managing global or regional therapeutic or research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. They will partner closely with study physicians and medical scientists in the delivery of the CDP, while allocating time to the mentoring and development of less experienced clinical staff. You will ensure projects adhere to Good Clinical Practice and regulatory requirements. In this role you will be able to deputize for the Global Clinical head (GCH) and independently lead development activities for an indication or subset of the Clinical Development plan. You will be responsible for overseeing development of the functional strategy or acting as a renowned expert in your own field and for the clinical, scientific, and value content delivery of the Clinical Development plan (CDP) to time and quality.
Typical accountabilities

• Defines strategies or leads AstraZeneca's response to complex technical issues for specific medical aspects in relation to current projects, new projects and broader therapeutic area strategy
• Provides expert advice in the therapeutic area, influencing the development according to the global business and Clinical Development plan
• Accountable for the clinical strategy and clinical execution of a portfolio of pre-clinical and clinical stage therapies.
• Build strategic and coordinated product development plans which are aligned with business objectives and are differentiated from competitor products.
• Closely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans
• Liaises with the internal and external medical community to follow developments within areas of expertise
• Contributes to or manages the development of the senior management team in area of expertise
• Leads regulatory communication and preparation of higher-level documents
• Supports the development of clinical documents in assigned project
• Accountable for the delivery of project according to quality, time, budgets and resources
• Responsible for all aspects of project strategy including preclinical, translational, Clinical Development, patient selection, regulatory and pediatric strategy.
• Responsible for maintaining a high degree of clinical project team effectiveness through collaboration and influence.
• Experience in mentoring and motivating teams in a highly matrixed environment.
• Demonstrated leadership qualities with focus on collaborative working skills, trust and openness, irrespective of cultural setting
• Demonstrated ability to lead, coach, and mentor junior physicians/scientists.

Essential for the role

• Physician with specialist training in Infectious Diseases/Pulmonary medicine/ allergy/ immunology /internal medicine OR a scientist with a higher degree and significant Clinical Development experience in the above specialties
• At least 5 years in Industry experience, in leading clinical trials to support approval (Phase 2-4) and regulatory knowledge.
• Experience in leading a clinical program to support an indication, including overall design, Clinical Development plan and Target Product Profile
• Experience in writing clinical aspects of clinical documents, briefing documents for regulatory interactions and played a critical role in writing sections of a submission dossier
• Previous experience in working cross functionally including leading cross functional study teams
• General understanding of medical statistics, safety, regulatory requirements.
• Organizational and project management skills
• Must demonstrate high integrity.

Desirable for the role

• Life Science-based degree at Masters or above (i.e. M.D., PHD, PharmD)
• Excellent general medical knowledge
• Track record of successful clinical delivery with demonstrated examples of strategic influence to clinical studies/programs

Date Posted
15-Dec-2023
Closing Date
28-Dec-2023
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 (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). 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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.