Global Clinical Program Lead, Immunology

Biopharma Careers; Cambridge, Northern (MA, KY); Hybrid; USD 288,000 - 432,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Equity-based incentive program

Paid vacation and holidays

Job summary

Biopharma Careers is seeking a Global Clinical Product Leader in Immunology to provide medical and scientific input across small molecules, biologics or cell therapy programs in late-stage development. You will drive cross-functional activities, shape development plans, and ensure studies meet regulatory expectations.

The role requires an MD/MD-PhD with 5+ years of pharma experience, strong communication, and leadership of global study teams, with a commitment to patient safety and ethical

Qualifications

• Medical degree (MD or MD-PhD) required with specialty in gastroenterology/gastrointestinal diseases and/or clinical immunology.
• Minimum of 5 years in pharma industry, with experience leading clinical trials to support approval (Phase 2-4).
• Knowledge of biostatistics, global regulatory environment, and pharmacovigilance relevant to the role.
• Experience leading or reviewing a clinical program to support an indication: design, development plan, and Target Product Profile.

Responsibilities

• Provide medical and scientific input into programs of small molecules, biologics or cell therapy for clinical stage assets.
• Lead governance interactions and co-lead study/program strategy for publications.
• Accountable for safety surveillance and for documents like protocol, SAP, informed consent, CSRs.
• Deliver clinical, scientific, and medical information to Regulatory Agencies, Ethics Committees, MCs and investigators.
• Induction and education of new Global Study Team members.

Skills

Clinical trial leadership

Regulatory knowledge

Biostatistics understanding

Cross-functional collaboration

Presentation skills

Education

MD or MD-PhD

Job description

**Global Clinical Product Leader, Immunology****Make a more meaningful contribution. Impact patients’ lives every day.**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 immunology to become a major player in the field. This Global Clinical Program Lead (GCPL) role in Late stage clinical development in Immunology is designed to help deliver on that ambition.**The role - Global Clinical Program Lead, Immunology**As GCPL in Gastroenterology, you will provide medical and scientific input into programs of small molecules, biologics or cell therapy for clinical stage assets and provide program leadership that is passionate about gastroenterology and clinical immunology. You will take responsibility for clinical development in cross-functional teams to support early to late phase clinical development activities. These include the creation of overall clinical development plans and clinical study design, writing study concepts and protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies.**In this role, you will be:**Responsible for study design concept deliveryResponsible for driving clinical and scientific decisions within Global Study Team remits together with other team membersAccountable for clinical, scientific, and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical PracticeAccountable 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.Accountable for scientific medical content at international investigator meetings, and support to local Marketing Companies (MC) for country level activitiesAccountable 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).Accountable for induction and education of new Global Study Team members.Work with GCH and TA leadership for identifying risks and proposing mitigation strategies to deliver successful phase IIb, III, IV or Life Cycle Management studiesDelivering 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**Leadership:**Clinical representative on indication in Global and Clinical Product Teams and/or sub-teamsLead governance interactions in conjunction with or as delegated by the GCH such as DRACs, DRCs, PRCsCo-lead the study and program strategy for publication development and approval of publications with the GCHLine management of project study physicians and scientists**Basic Qualifications**Medical degree (MD or MD-PhD) required, with specialist training or experience in gastroenterology/gastrointestinal diseases and/or clinical immunologyMinimum of 5 years in pharma industry, with experience in leading clinical trials to support approval (Phase 2-4)Knowledge of biostatistics, global regulatory environment, and pharmacovigilance relevant to the roleExperience in leading or reviewing 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 collaboratorsKnowledge and experience to work across projects, with a fast-learning curve when moving into new disease areasWhen 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.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.