Job Description

Our client is a Biotech company with a focus on neuroscience drug development with early-stage and late-stage clinical studies, now have approval for a Director, Clinical Research Physician role working within the Clinical Science team. This hire will work closely with a multidisciplinary team including biostatisticians, regulatory affairs, clinical operations and data management, toxicologists, pharmacovigilance, medical affairs, market access, etc., as necessary. This hire will be based in the UK, working remotely from there.

As Medical Expert, you will provide oversight and leadership on clinical study setup and document preparation, protocol development, ongoing medical monitoring, safety reporting, medical review for data cleaning, narrative writing, clinical study report generation, preparation of dossiers for regulators submission (INDs, NDAs, MAAs, etc.).

This hire will provide medical expertise on issues related to the trial, made by internal organs, researchers, authorities and relevant external entities such as investigators, sites and/or CRAs, to the trial in question.

Additionally, this Medical Expert will work as an external engagement speaker on behalf of the company, attending advisory boards, congresses, F2F meetings, steering committee meetings, data presentation, etc.

Responsibilities include:

· Medical lead supporting the clinical project management team with medical issues related to clinical trials, e.g. medical monitoring of clinical trials, establishing plans and seeking unconformity signs and responding to questions raised by the investigators.

· Leadership on medical and scientific quality of the clinical trial protocol, of relevant clinical documents for completeness and accuracy and of the clinical trial report.

· Leadership on medical revision of the notifications of SAEs before submitting them to the authorities.

· Oversight and medical review of the IMPD (Investigational Medicinal Product Dossier) and IB (investigators brochure).

· As Medical Expert ensure the review of medical and scientific publications of results of the trial. Also, the review of medical reports of safety information.

· Presentations in investigators meetings, participations in meetings and trainings related do the studies and pipeline.

Requirements include:

· MD is required. Additional residency in Psychiatry or Neurology, or formal training in Psychological Treatments, Neuroscience, etc. is preferred.

· 5+ years of relevant clinical research / clinical development experience in neuroscience, working to ICH/GCP guidelines in the biotech or pharmaceutical industry, or clinical setting is preferred.

· Experience in contributing to clinical study design, clinical protocol development, clinical reports, etc.

· Medical monitoring and safety reporting of Phase I-III trials.

· Clinical Pharmacology experience is preferred.

· Superb communicator of technical and scientific information, as company representative and speaker.

· Able to travel within the EU region and EU regional passport as required.

· Exhibits high motivation and high energy level, self-starter.