Global Clinical Program Lead, Respiratory and Immunology Late Development

About the role

Contribute to our growing pipeline. Join a place with the commitment, knowledge and backing from the business to continue expanding our pipeline. We have an exciting opportunity for a Global Clinical Program Lead to join our team within Late Respiratory and Immunology Clinical Development.

Responsibilities

• Accountable to the Global Clinical Head for a significant proportion of the clinical program, usually an indication-aligned cluster of clinical studies.
• Supervise a team of Global Development Medical Directors and/or Global Development Scientist Directors, and also work cross functionally to support the design, conduct, monitoring and data interpretation of multiple studies.
• Ensure that the clinical data collected within the studies will allow determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally.
• Set the vision and goals against therapeutic area leadership priorities and product strategy; ensure timely decision making; facilitate the balance of cost/time/quality against clinical development objectives; develop relevant risk mitigation strategies; enable quick and effective troubleshooting; represent the program at health authority interactions; review publications aligned to your program; and seek/share findings through your portfolio of studies.
• Operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.

Requirements

• MD, MBBS, PhD, or PharmD, with specialist training or significant experience in either pulmonary medicine and extensive experience from clinical development in pharmaceutical industry or academia.
• Minimum 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 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 and played a critical role in writing sections of a submission dossier.
• 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.

Qualifications

• PhD (or other complementary degree) in scientific field.
• Education in Pharmaceutical Medicine.
• Pharmaceutical industry R&D experience, and in particular involvement in major clinical achievements and factors which influence drug development.
• Experience in matrix team environment with interplay between clinical, commercial, drug safety and regulatory.

Skills

• Strong scientific and clinical background.
• Excellent communication and interpersonal skills.
• Ability to manage complex projects and teams.
• Experience in regulatory affairs and clinical trial operations.

Benefits

• The annual base salary for this position ranges from $288,059 - $432,088.
• In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program.
• Benefits offered include 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.

Pay

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.

Schedule

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.