Global Clinical Program Lead
Do you have expertise in Respiratory clinical development and passion for developing late phase clinical program strategies?
Contribute to our growing pipeline. Join a place with the commitment, knowledge and backing from the business to continue expanding our pipeline. With one of the broadest and deepest pipelines, we are determined to keep contributing and pushing forward. When we get it right there’s nothing more motivating.
We have an exciting opportunity for a Global Clinical Program Lead to join our team within Late Respiratory and Immunology (R&I) Clinical Development. In Late Development Respiratory, you will work with a dedicated Respiratory team that’s growing fast and building a consistent track record of success. We make bold moves at the groundbreaking. Redefining molecules to change the practice of medicine. This role can be based in Gothenburg (SE), Warsaw (Poland), Cambridge (UK) or Gaithersburg (US).
As a Global Clinical Program Lead, you are accountable to the Global Clinical Head for a significant proportion of the clinical program, usually an indication-aligned cluster of clinical studies. This role is normally applied to portions of the program that have the highest degree of complexity based upon the known science or the size of the program, and may also include a third-party collaboration.
In this capacity, you will supervise a team of Global Development Medical Directors and/or Global Development Scientist Directors, and also work cross functionally to support the design, conduct, monitoring and data interpretation of multiple studies. You will ensure that the clinical data collected within the studies will allow determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally. As such, you will get the chance to be strategic and patient focused, generating opportunity and value for the asset or indication with an entrepreneurial approach to maintain a driven advantage.
You will set the vision and goals against therapeutic area leadership priorities and product strategy; ensure timely decision making; facilitate the balance of cost/time/quality against clinical development objectives; develop relevant risk mitigation strategies; enable quick and effective troubleshooting; represent the program at health authority interactions; review publications aligned to your program; and seek/share findings through your portfolio of studies.
The Global Clinical Program Lead will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.
What you’ll do
Clinical, scientific, and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical Practice
Scientific medical input to all relevant study documents (including and not limited to protocol, statistical analysis plan, amendments, informed consent, case report forms, safety, and risk-based monitoring plans) to ensure consistency within clinical program and alignment with scientific rationale.
Scientific medical content at international investigator meetings,and support to local Marketing Companies (MC) for country level activities
Safety surveillance on a study level and/or program level including the process for Adverse Events (AE)/ Serious AE reporting.
Reviews (with the GCH) the Clinical Study Report and plays key role in preparation and production of relevant sections (Introduction, Results, Discussion).
Induction and education of new Global Study Team members.
May also contribute to clinical trial improvement workstreams on behalf of the Clinical function.
Accountable to GCH (or delegate) and TA leadership for identifying risks and proposing mitigation strategies to deliver successful phase IIb, III, IV or Life Cycle Management studies
Delivery of clinical, scientific, and medical information/query responses to Regulatory Agencies, Ethic Committees, Marketing Companies (MCs), and investigators/sites, and provides clarifications as well as solves clinical, scientific, and medical issues in the Global Study Team
Clinical representative on indication in Global and Clinical Product Teams and/or sub-teams
Co-leads the study and program strategy for publication development and approval of publications with the GCH
Essential for the role
Science or medical degree (e.g. MD, PhD, PharmD), with specialist training or significant experience in either pulmonary medicine or allergy/immunology/autoimmune diseases/vaccines/infectious diseases and extensive experience from clinical development in pharmaceutical industry or academia.
Minimum of 5 and ideally more than 8 years in pharma industry, with experience in leading clinical trials to support approval (Phase 2-4)
Knowledge of biostatistics, global regulatory environment, and pharmacovigilance relevant to the role
Experience in leading a clinical program to support an indication: design, clinical development plan and Target Product Profile.
Experience in writing clinical aspects of briefing documents for regulatory interactions and played a critical role in writing sections of a submission dossier
Good presentation skills and effective communication with internal and external collaborators
Knowledge and experience to work across projects, with a fast-learning curve when moving into new disease areas
Desirable for the role
PhD (or other complementary degree) in scientific field
Education in Pharmaceutical Medicine
Pharmaceutical industry R&D experience, and in particular involvement in major clinical achievements and factors which influence drug development.
Experience in matrix team environment with interplay between clinical, commercial, drug safety and regulatory
AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It’s our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees’ varying needs, and offers valuable choices.
At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and ignite 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. Always committed to lifelong learning, growth and development! Take the lead to make a bigger impact!
Here we need leadership at every level – Physicians who not only have expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences. With that kind of remit comes great responsibility and the opportunity to make a big impact.