Medical Director

Career insight

A Medical Director in Clinical Development will be responsible for the trial design, medical monitoring, safety and sometimes leadership of a drug portfolio.  The 3 main responsibilities of a Medical Director (Clinical Development) are Medical Monitoring, Trial Design and Clinical Execution.

Medical Director, Clinical Development – Medical Monitoring

A Medical Director will focus much of their time in Medical Monitoring. This is a large scop term but essentially refers to monitoring all safety related matters and live trial results. Should an ADR/ADE occur a medical monitor will determine how to code and interpret these events. Decisions regarding drug safety, risk:benefit, how well a trial is progressing will rely on Medical Monitors (at least from Phase I - III). This provides a layer of safety to the patients and decision makers. It allows for quicker and better decision making at the top layer.

Medical Director, Clinical Development - Trial Design and Contribution

The Med Directors will contribute greatly to the clinical development, strategy and execution of trials. The final Stop:Go decision making will usually be with the VP or CMO depending on company size, however many executive medical directors at Large Pharma will also have this responsibility. The medical director brings their knowledge of the disease and works with the Clinical Scientists, VPs and Clin Ops people to design future clinical trials.

Medical Director, Clinical Development - Operations and delivery of information.

A medical director is expected to support many operational tasks such as the medical monitoring (already discussed), study protocol design, writing (or guiding the medical writing/clinical scientist team to write) and interact with investigators, medical experts and answer medial questions related to drugs. The data, insights and communication is essential for the VP and CMO to make informed decisions on the next stages of the clinical plan. Functional responsibilities here can also include GCP, ICH, FDA/EMA Submissions, IND Filings, Vendor management and more.

Requirements for a Medical Director

• A Medical Degree and board certified oncology / haematologist (preferred).
• If not industry experience, then a very strong relevant academic background (usually previous clinical experience in that field).
• Medical Monitoring, medical advice and answering questions, detail orientated and highly analytical. .
• Trial design, able to build or contribute to clinical strategies, engage with translational team, biomarker and clinical operations team to align on correct trial strategy.
• Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents. Compiles and maintains Investigators’ Brochures (IB)

Salary and benefits:

• $180,000 - $260,000
• Bonus: 20-30%
• Stocks: 20-30%
• Typical extras: Paid travel or relocation

Further information:

Should you be interested in working as a Medical Director in Clinical Development or need more advice on your career, then let us know. We are always searching for people with this background and are happy to discuss our clients and which companies are hiring (now or near future). All conversations are strictly confidential.