Medical Director (Cro Services / Cardiovascular)

Job Title: Medical Director

Job Location: United States or Canada - Remote

Job Overview:

Primary responsibilities include medical and safety oversight of clinical trials as well as corporate support for business opportunities. The Medical Director provides Medical Monitoring services to clinical trials with the aim to monitor the safety and wellbeing of study participants, integrity of the project data in accordance with the clinical trial protocol/clinical study protocol (or equivalent documents), standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable directives and regulatory requirements.

Job Duties and Responsibilities: Job duties differ from project to project and are described in the contract, project-specific Plans (SMP; MMP), and/or other documents agreed with the Sponsor. Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and in general include but are not limited to the following:

Medical Monitoring:

• Provides Medical oversight of projects to ensure GCP/national and international regulatory requirements, Policies/SOPs/WPs, and Sponsor directives are followed.

• Provides Medical consultation to Sponsors and project teams for protocol development and/or project activities, as indicated.

• Maintains availability to the sites and project team including the Sponsor to ensure that medical questions or medical aspects of project-related questions (e.g. safety, general protocol questions, subject eligibility, inclusion/exclusion criteria, screening, randomization, unblinding, dosing, termination and discontinuation, IP-specific questions, etc.) are answered or communicated for resolution.

• Develops/updates the Medical Monitoring Plan (MMP), circulating it for approval within the company and with Sponsor

• Reviews project specific plans, including the Safety Management Plan (SMP).

• Reviews and advises on project-related documents (e.g. study protocol, Informed Consent Form, clinical study report, etc.), as indicated.

• Develops and/or reviews project-related documents and reports, assesses and interprets project results.

• Reviews medical literature in the scope of preparation of project-related documents and provides input for preparation of the respective documents.

• Reviews and assesses issues related to protocol compliance, including protocol deviations/violations, development of the corrective and preventative actions.

• Trains CRAs and other team members on different topics, including medical and/or safety aspects of the project or therapeutic area/indication.

• Reviews laboratory results and lab/ECG alerts, as required.

• Provides Medical review and assessment of SAEs, adverse events of special interest, SAE narratives, expedited and periodic safety reports, as requested.

• May write medical sections of periodic safety reports (e.g., risk-benefit assessments) and/or review safety data for trends.

• Provides Medical review of study data, as per the MMP/Medical data review plan, for clarifying and resolving data inconsistencies, query management, trend assessment, etc.

• May review requests from Regulatory Authorities and/or Ethic Committees/IRBs and related activities with preparation of responses, when requested.

• Escalates issues and notifies Line Manager, Project Manager, and/or other responsible staff if urgent safety issues are identified.

• Works closely with other functional groups and departments including but not limited to Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics and QA to ensure that medical operational functions are executed effectively as per contract.

Business Development Support (as needed):

• Supports Business Development by preparing protocol considerations for new Proposals, answering Requests for Information, etc.

• Participate in capability and bid defense meetings, as needed, to provide medical and scientific advice for potential new projects

• May work with Feasibility to identify potential sites for a project; review feasibility questionnaires; and/or discuss capabilities by e-mail or phone.

Supervisory Responsibilities:

• Will not have direct reports but will be responsible for mentoring and assisting in the training of others.

Job Requirements:

Education

• MD (or country-specific equivalent) required, postgraduate training/eligibility for licensure preferred.

Experience

• Minimum of 3 years of direct cardiovascular experience strongly preferred

• At least 5 years of experience research experience post-training. CRO experience is preferred

• Prior experience across the spectrum of Medical Monitoring activities, including Medical review of safety information

• Prior experience in development and delivery of therapeutic area/protocol-specific trainings and presentations

• Experience representing the company in meetings with pharmaceutical/biotechnology companies is preferred

Skills/Competencies

• Clinical thinking: ability to perform critical review and answer questions of medical nature from sites, project team, and Sponsor in accordance with ICH GCP guidelines, project specific documents to ensure patient safety, data integrity and successful completion of project.

• Deep understanding of the scientific basis for therapies and drug-induced diseases.

• Comprehensive knowledge of medical device, vaccines and drug development process.

• High level understanding of pharmacovigilance processes.

• Strong knowledge of the drug/device/vaccine development process.

• Extensive knowledge of GCP/applicable regulations and guidance's, including but not limited to national/regional regulations as well as ICH Guidance.

• Comfortable communicating both internally and externally, including delivering presentations

• Maintain a calm and positive winning attitude, and excellent decision-making skills

• Assist in team's success through establishing and clear articulation of goals

• Ability to train and mentor others

• Able to prioritize action items and maintain a good sense of urgency

Capabilities

• Proficient in the use of computers and Microsoft Office applications

• Ability to travel occasionally, in support of business needs

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