Senior/Executive Medical Director

The Role:

The Medical Monitor is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position is expected to work independently across functional teams and lead/manage others to ensure the timely execution of the clinical development plan. The successful candidate will work independently in conjunction with the medical and development leads in the development of protocols, analysis of clinical trial data, literature searches, and summary of key data. This person is also expected to make significant contributions to the overall clinical development plan. Closely collaborates with Clinical Operations in the overall conduct and timely execution of clinical trials. Works in collaboration with other key stakeholders in the development of the clinical program strategy and other activities towards achieving corporate objectives.

In the role you will:

1. Act as medical monitor to clinical trial(s) Author and/or review key technical and clinical documents, including but not limited to clinical study protocols, clinical study reports, investigator’s brochures, annual reports, and clinical sections of regulatory submissions.
2. Provide medical oversight, ensure patient safety, and maintain the scientific integrity of the clinical trial while adhering to regulatory guidelines.
3. In conjunction with clinical operations team, participate in selection of investigators, clinical sites, and vendors (including CRO). Accountable for the clinical/scientific execution of the clinical protocol.
4. Be accountable for the scientific aspects of the implementation and conduct of a clinical trial with both internal and external stakeholders (e.g., investigator meeting presentations, data review and summary, protocol deviation review, etc.).
5. Create and maintain clinical development plans to be aligned with key strategic documents (e.g., target product profile).
6. Develop and perform clinical data review plans for clinical studies.
7. Participate in and prepare presentations for scientific meetings such as DSMB, steering committees, scientific advisory boards, etc.
8. Build relationships with external scientific and clinical thought leaders.
9. Assist in the authoring of abstracts and preparation of posters or presentations for external presentation, as well as manuscripts.
10. Assist in the development of clinical trial data collection in the EDC system and Case Report forms (CRFs) and assist in the analysis of clinical trial data as needed.
11. Coordinate efforts and collaborate with internal stakeholders (i.e., regulatory, translational, biostatistics, pharmacology/toxicology) to allow efficient execution of clinical studies.
12. Work independently as well as contribute as part of an interdisciplinary team.
13. Maintain flexibility to meet deadlines and to respond to frequent and/or unexpected changes.

Key Responsibilities and Performance Metrics:

1. Safety Monitoring and Oversite: Monitor and assess patient safety throughout the trial, including timely review and assessment of adverse events and safety data. Implement safety protocols and actions. Metrics: number of adverse events managed and resolved within specified timeframes in accordance with regulatory requirements.
2. Protocol Adherence: Ensure that the clinical trial is conducted according to the approved protocol and in compliance with regulatory requirements. Identify and address protocol deviations. Metrics: Percentage of protocol deviations identified and addressed promptly with appropriate documentation and understanding of impact.
3. Data Review and Quality: Review and analyze clinical trial data at the appropriate time points including efficacy and safety. In conjunction with clinical operations and data management, ensure data accuracy and completeness and identify and address data discrepancies. Metrics: data quality and completeness ratings.
4. Communication: Maintain timely and effective communication with stakeholders including the clinical trial team, investigators, and regulatory authorities as needed. Metrics: Feedback from stakeholders including sites on the quality and timeliness of communication.
5. Risk Management: Proactively identify potential risks and develop and implement mitigation strategies to address them. Metrics: Knowledge of how to interrogate risk mitigation components. Identification of sites which need to improve monitoring and safety management. Ability to reduce deviations, identify and manage data alarms, produce high quality queries, while limiting site burden.

Qualifications: About you

1. MD or international equivalent with clinical research experience. (5 years minimum for senior, 8 years minimum for principal)
2. Prior industry experience preferred; oncology experience preferred.
3. Broad and solid understanding of functional areas of drug development, including but not limited to, preclinical, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management).
4. Candidates must possess highly effective communication skills and be fluent in the English language, both written and verbal.
5. Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust overall clinical development strategy.
6. Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness, and the ability to perform as a respected team member and leader.
7. Ability to work independently and to organize priorities and deliverables.
8. The candidate should be detail-oriented, a self-starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.