Global Clinical Program Lead (Physician), Late Respiratory Dev

at  AstraZeneca

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 accountable for clinical, scientific, and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical Practice
• Is accountable for 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.
• Is accountable for scientific medical content at international investigator meetings, and support to 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 key role in preparation and production of relevant sections (Introduction, Results, Discussion).
• Is accountable for 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

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.

MESSAGING AND EXTERNAL IMPACT ACCOUNTABILITIES

• Maintains high degree of understanding and awareness on new and emerging medical development advances in the relevant therapeutic area globally.
• Builds trustworthy relationships with steering committees/executive committees, academic research organizations and clinical research organizations as applicable
• Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues
• Provides guidance for externally sponsored trials in cooperation with regional MCs

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. The GCPL 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.

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 and ideally more than 8 yrs experience in pharma industry, with experience in leading late phase clinical trials to support approval
• 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
• Plays a critical role in writing sections of a submission dossier
• Good presentation skills and effective communication with internal and external collaborators
• Knowledge and experience working across projects, with a fast-learning curve when moving into new disease areas
• Line management experience

BEHAVIORS REQUIRED OF THIS ROLE:

• Demonstrated leadership qualities with focus on collaborative working skills, trust, and openness, irrespective of cultural setting
• Proven teamwork and collaboration skills
• Demonstrates AstraZeneca Values and Behaviors