Global Clinical Program Lead

Global Clinical Program Lead

Location: Boston, MA US

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.

Basic Qualifications:

• 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

Preferred Qualifications:

• 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

The annual base salary for this position ranges from $288,059 - $432,088. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

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 ambitious world.

Date Posted

24-Mar-2026

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.