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Global Clinical Program Lead - Baltimore, United States - AstraZeneca
Description
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.
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 contributing 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 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 phas 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.
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.
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 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).
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 key role in 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 ensure BD completeness; defend 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.
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 applicableWorks 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
People Management:
5-8 direct reports
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
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.#J-18808-Ljbffr
