Global Clinical Program Lead

Job Title: Global Clinical Operations Program Director, R&I Lead

Location: Office Based Role in Boston MA with Flexibility

Make a more meaningful contribution. Impact patients’ lives every day.

AZ’s vision is to grow and expand the indications and assets in late phase respiratory and or immunology therapy areas to become a major player in the field.

This Global Clinical Program Lead (GCPL) role in late phase clinical development in R&I is designed to help deliver on that ambition.

What you will do:

GCPL is responsible for the design, conduct, monitoring, data interpretation and reporting of immunology clinical trials within the program to ensure clinical data collected allow to assess the benefits and risks of the compound, aligned with the Global Clinical Development Program strategy. The GCPL will ensure studies are operated according to the highest scientific, ethical standards and are compliant with internal as well as regulatory agency requirements.

The GCPL will be able to deputize for Global Clinical Head (GCH) and lead independently on development activities of the clinical development plan.

Typical Accountabilities/Responsibilities:

• Global Clinical Program/Study design, concept, delivery

• Drives clinical and scientific decisions within Global Study Team remits collaboratively

• 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) ensuring 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 CSR playing key role in preparation and production of relevant sections (Introduction, Results, Discussion)

• Induction and education of new Global Study Team members; may contribute to clinical trial improvement workstreams

• Accountable to GCH and TA leadership for identifying risks and proposing mitigation strategies to deliver successful phase IIb, III, IV or LCM studies

• Delivery of clinical, scientific, and medical information/query responses to Regulatory Agencies, Ethic Committees, Marketing Companies (MCs), and investigators/sites providing clarifications and solves clinical, scientific and medical issues in the GST

• Acts as the Clinical representative on indication in Global and Clinical Product Teams and/or sub-teams

• Leads governance interactions in conjunction with or as delegated by the GCH such as DRACs, DRCs, PRCs

• Co-leads the study and program strategy for publication development and approval of publications with the GCH

• Line management for a team of 5-8 physician researchers

Essential Education, Skills and Experience Required for this Role:

• Medical degree (e.g. MD, with specialist training or significant experience in either allergy/immunology/autoimmune diseases and extensive experience from clinical development in pharmaceutical industry

• Experience in matrix team environment with interplay between clinical, commercial, drug safety and regulatory

• Minimum of 5 yrs experience in pharma industry, with experience in leading late phase clinical trials to support approval

• Knowledge of biostatistics, global regulatory and pharmacovigilance

• 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 for writing sections of a submission dossier

• Good presentation skills and effective communication with internal and external collaborators

• Line management experience

• Demonstrated leadership qualities with focus on collaboration, trust and open communications

AstraZeneca an Employer of Choice:

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! AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package!  If you have what it takes to create a culture of courageous leadership, creativity and collaboration, please apply today!

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four 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 ambitious world.