Global Clinical Program Lead

AstraZeneca • Boston, MA

1d • Hybrid

About The Position

The Global Clinical Program Lead is accountable for the clinical program for a respiratory disease indication or for a significant proportion of the clinical program as delegated by Global Clinical Head (GCH). The GCPL provides the clinical position and voice to the global product team. In this role, you will be responsible for 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.. The GCPL ensures studies are operated according to the highest scientific and ethical standards and in compliance with internal SOPs, local regulations, Good Clinical Practice and regulatory requirements. Scientific and medical responsibilities include: Study design concept delivery Driving clinical and scientific decisions within Global Study Team 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 Accountable for scientific medical input to all study documents to ensure consistency within clinical program and alignment with scientific rationale. Accountable for scientific medical content at investigator meetings, and support to local Marketing Companies for country level activities Accountable for safety surveillance on a study level and/or program level including the process for Adverse Events reporting. Reviews the Clinical Study Report and plays key role in preparation and production of relevant sections. Accountable for induction and education of new Global Study Team members. Delivery of clinical, scientific, and medical information/query responses to Regulatory Agencies, Ethic Committees, Marketing Companies (MCs), and investigators/sites. Clinical representative on indication in Global and Clinical Product Teams and/or sub-teams Leads governance interactions in conjunction with the GCH Co-leads the study and program strategy for publication development and approval of publications with the GCH Regulatory interactions: Plays key role in development of the clinical sections of regulatory submission documents Provides leadership in writing responses to comments/questions of Regulatory Authorities for clinical modules Leads the strategy for the development of regulatory agency briefing documents and ensure completeness; may also defend positions during regulatory meetings 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 collaboration with regional MCs.

Requirements

• MD degree
• 5+ years working in the pharmaceutical industry with 2+ years' 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.
• 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

Nice To Haves

• Specialist training in either allergy/immunology/autoimmune disease and experience in clinical development in industry.
• Experience in writing clinical aspects of briefing documents for regulatory interactions and played a critical role in writing sections of a submission dossier
• Line management experience

Responsibilities

• Study design concept delivery
• Driving clinical and scientific decisions within Global Study Team
• 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
• Accountable for scientific medical input to all study documents to ensure consistency within clinical program and alignment with scientific rationale.
• Accountable for scientific medical content at investigator meetings, and support to local Marketing Companies for country level activities
• Accountable for safety surveillance on a study level and/or program level including the process for Adverse Events reporting.
• Reviews the Clinical Study Report and plays key role in preparation and production of relevant sections.
• Accountable for induction and education of new Global Study Team members.
• Delivery of clinical, scientific, and medical information/query responses to Regulatory Agencies, Ethic Committees, Marketing Companies (MCs), and investigators/sites.
• Clinical representative on indication in Global and Clinical Product Teams and/or sub-teams
• Leads governance interactions in conjunction with the GCH
• Co-leads the study and program strategy for publication development and approval of publications with the GCH
• Plays key role in development of the clinical sections of regulatory submission documents
• Provides leadership in writing responses to comments/questions of Regulatory Authorities for clinical modules
• Leads the strategy for the development of regulatory agency briefing documents and ensure completeness; may also defend positions during regulatory meetings
• 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 collaboration with regional MCs.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees