Overview
Medical Director Neuroimmunology serves as the medical responsible on clinical trial(s), overseeing execution of clinical trial activities in assigned projects for a top-5 pharma company.
Responsibilities- Engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to develop scientific rationale for clinical trials.
- Develop and/or oversee 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 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.
- Medical Degree (mandatory).
- Neuroimmunology experience is a must.
- Myasthenia gravis experience would be a big plus.
- Able to communicate effectively in English.
- Experience leading protocol development.
- Requires substantial professional experience in related therapeutic area/indication including clinical trials.
- Professional experience in the execution of clinical trials as medical responsible (3+ years) with at least one clinical trial within neuroimmunology.
- 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 seamlessly with project/program/functional teams both face to face and remotely.
- Various annual leave entitlements.
- Range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximise savings and plan with confidence.
- Global Employee Assistance Programme, Life Works, offering 24‑hour access to a global network of specialised professionals.
- Life assurance.
- Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
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