Global Clinical Program Lead (physician), Late R&I

Job Title: Global Clinical Program Lead, Late R&I

Location: In office at Boston Seaport with Flexibility

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

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 chipping in and pushing forward. When we get it right there’s nothing more motivating.
 

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

This Global Clinical Program Lead (GCPL) role in Late stage 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, as aligned with overall clinical development program strategy globally, including indications. You will ensure studies are operated according to the highest scientific and ethical standards and in compliance with internal SOPs, local regulations, GCP and regulatory 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:

• Is responsible for study design concept delivery

• Is responsible for driving clinical and scientific decisions within Global Study Team remits together with other team members

• Is charged with clinical, scientific, and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical Practice

• Is culpable for scientific medical input to all relevant study documents (including but 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.

• You will be responsible for scientific medical content at international investigator meetings, and support local Marketing Companies (MC) for country-level activities

• Is accountable for 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 a key role in the preparation and production of relevant sections (Introduction, Results, Discussion).

• Is accountable for the induction and education of new Global Study Team members. May also contribute to clinical trial improvement workstreams on behalf of the Clinical function.

• May be 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

• 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 of project study physicians and scientists

Regulatory Interactions: 

• Plays a key role in the development of the clinical sections of regulatory submission documents and is accountable to GCH for their content

• Provides a leadership role in writing responses to comments/questions of Regulatory Authorities for clinical modules

• Leads as delegated by GCH the strategy for the development of regulatory agency briefing documents (BD) and ensures BD completeness; defends BD positions during regulatory meetings as delegated by GCH

Scientific Medical & Analytical Accountabilities:

• Stays up to date with relevant scientific literature, and can message key impactful points, as applicable

• Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation

• Scientific/medical expertise for the Product Team, in analyses and interpretation of trial data.