Medical Director

ICON plc • Blue Bell, SD

11d

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. The Medical Director in immunology (Lupus SLE) serves as a medical responsible on clinical trial(s), overseeing execution of clinical trial activities in assigned projects. This role is client dedicated to a top-5 pharma company. The role requires the ability to engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials. The Medical Director will develop and/or oversee the preparation of clinical development plans, study concept sheets, study protocols or regulatory documentation in collaboration with clinical and project team members for assigned indication(s)/products or with external partners for collaborative studies. The role also involves actively contributing to or overseeing medical writing of medical sections of study protocols, investigator brochure and other regulatory documents. The Medical Director will manage the clinical team supporting the clinical trial, and manage, mentor and develop assigned staff, as appropriate. The role includes overseeing all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders, supporting the review, analysis and interpretation of study data, and supporting communication of study results as assigned.

Requirements

• Medical Degree (mandatory)
• Immunology experience (Lupus SLE)
• Able to communicate effectively in English
• Experience leading protocol development
• Substantial professional experience in related TA/indication including clinical trials
• Professional experience in the execution of clinical trials as medical responsible (3+ years)
• Previous experience in medical monitoring, medical data review, eligibility review during recruitment, presentations at investigator meetings and trainings, protocol writing, regulatory responses
• Experience in design, set up, conduct and evaluation of clinical trials
• Experience working in a cross-functional multi-site team environment
• Working knowledge of GCP, ICH, US FDA and EMA regulations
• Ability to work in an intense, fast paced, global work environment
• Pro-active, problem-solving, constructive attitude
• Strong oral and written communication skills, including presentations (posters, paper, seminars) to internal and external parties
• Ability to collaborate in a seamless fashion with project/program/functional teams both face to face and remotely
• Having the legal right to work in the country where the role is based.

Responsibilities

• Serve as a medical responsible on clinical trial(s), overseeing execution of clinical trial activities in assigned projects.
• Engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials.
• Develop and/or oversee the preparation of clinical development plans, study concept sheets, study protocols or regulatory documentation in collaboration with clinical and project team members for assigned indication(s)/products or with external partners for collaborative studies.
• Actively contribute to or oversee medical writing of medical sections of study protocols, investigator brochure and other regulatory documents.
• Manage the clinical team supporting the clinical trial.
• Manage, mentor and develop assigned staff, as appropriate.
• Oversee all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders.
• Support the review, analysis and interpretation of study data.
• Support communication of study results as assigned.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Senior