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 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 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, 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
Line management of project study physicians and scientists
You will need
M.D. with specialist training or significant experience in allergy, immunology or autoimmune diseases.
At least 5 years of relevant clinical development experience, including study design, protocol development, trial implementation, monitoring, data interpretation, and reporting.
Experience in clinical development and working within cross-functional teams.
Knowledge of biostatistics, global regulatory requirements, pharmacovigilance, GCP, and clinical trial safety.
Strong analytical, problem-solving, teamwork, and influencing skills.
Excellent written and verbal English communication skills.
Strong presentation and stakeholder engagement capabilities.
Ability to work effectively across global teams and travel as required
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 bold world.
Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
