Director, Clinical Research Physician (CNS)

TN United Kingdom; Greater London; Remote; GBP 80,000 - 120,000; Full time

Job summary

An established industry player in biotech is looking for a Director of Clinical Research Physician specializing in neuroscience. This role offers the opportunity to lead clinical studies, oversee medical monitoring, and ensure the scientific integrity of clinical protocols. You will collaborate with internal teams and external stakeholders while representing the company at various events. The position supports remote work, providing flexibility while contributing to groundbreaking advancements in drug development. If you are a proactive medical expert with a passion for clinical research, this is the perfect opportunity for you.

Qualifications

• 5+ years of experience in clinical research/development in neuroscience.
• Experience following ICH/GCP guidelines in biotech or pharma settings.

Responsibilities

• Oversee clinical study setup and protocol development.
• Ensure medical quality of clinical protocols and documents.
• Present data at investigator meetings and advisory boards.

Skills

Clinical Research

Medical Monitoring

Safety Reporting

Clinical Study Design

Excellent Communication Skills

Education

MD Degree

Residency in Psychiatry or Neurology

Job description

Job Description

Our client is a biotech company specializing in neuroscience drug development, conducting both early-stage and late-stage clinical studies. They are seeking a Director, Clinical Research Physician (CNS) to join their Clinical Science team. This position is based in the UK and offers remote work from there.

As a Medical Expert, you will oversee clinical study setup, document preparation, protocol development, medical monitoring, safety reporting, data review, narrative writing, clinical study report generation, and dossier preparation for regulatory submissions (INDs, NDAs, MAAs, etc.).

You will provide medical expertise on issues related to the trial, liaising with internal teams, investigators, authorities, and external entities such as sites and CRAs. Additionally, you will serve as an external speaker, attending advisory boards, congresses, meetings, and presenting data.

Responsibilities include:

1. Medical leadership supporting the clinical project team with medical issues, monitoring, and responding to investigator questions.
2. Ensuring the medical and scientific quality of clinical protocols, documents, and reports.
3. Reviewing SAE notifications before submission to authorities.
4. Overseeing and reviewing IMPD and Investigator's Brochure.
5. Reviewing scientific publications and safety reports related to the trial.
6. Presenting at investigator meetings and participating in study-related events.

Requirements include:

• MD degree required; residency in Psychiatry or Neurology, or training in Neuroscience or Psychological Treatments is preferred.
• At least 5 years of relevant experience in clinical research/development in neuroscience, following ICH/GCP guidelines, in biotech, pharma, or clinical settings.
• Experience in clinical study design, protocols, and reports.
• Experience with medical monitoring and safety reporting for Phase I-III trials.
• Clinical Pharmacology experience is a plus.
• Excellent communication skills, capable of representing the company and speaking publicly.
• Ability to travel within the EU and hold an EU regional passport.
• Self-motivated, energetic, and proactive.