Clinipace is a global full-service clinical research organization (CRO) serving the unique needs of venture-backed, mid-tier and strategic pharmaceutical, biotechnology and medical device firms. We help our customers advance drug candidates to deliver successful stakeholder and patient outcomes. We leverage extensive therapeutic knowledge, clinical trial expertise, and comprehensive innovative technology to support life science firms in achieving some of their most important goals: Executing regulatory strategies, optimizing clinical development timelines and completing high quality trials. We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development. Clinipace associates are passionate about their lives and bring that same passion to their work at Clinipace.
Work Location: United States | North Carolina (Morrisville)
Job Code: 4694
Job Title: Medical Director - Oncology (Remote)
Job... Location: Morrisville, NC (home based / remote)
This remote, home-based position provides and exciting opportunity to combine a diverse range of medical monitoring duties with support for corporate Business Development activities.
Due to broad scope of this role, successful candidate will demonstrate excellent clinical thinking, communication and leadership skills. Medical Director will be expected to attend and present at professional and internal and external project meetings..
Detailed description below:
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 well being 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. Responsibilities include medical supervision of assigned projects from both a medical and scientific perspective. The Medical Director provides and/or oversees medical monitoring activities including protocol development, development and/or review of project-specific Medical Monitoring Plan (MMP), review of other project-specific plans, responding to medically related questions, answering Medical questions arising at any stage of a clinical trial, and maintaining medical oversight for the conduct of a clinical trial. Reviews of medical data and/or safety information may be a regular part of the position. The Medical Director acts as liaison between the Sponsor/Client who is responsible for medical decisions made in a project, the investigational sites and the project team. To perform functions, he/she may need to be available up to 24 hours / 7 days a week. Scope of responsibilities of the Medical Director depends on the contract with each Sponsor. The Medical Director also supports Business Development activities, as requested.
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 (as applicable), 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. The MM does not instruct the site how to manage a patient from the medical/clinical prospective but advises how to understand the protocol and other applicable project requirements.
• Develops/updates the Medical Monitoring Plan (MMP), circulating it for approval within Clinipace and externally (with Sponsor); maintaining the MMP up-to date at all times during the project, escalating deviations from the MMP.
• 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.
• May provide training to other medical monitors.
• Attends internal and external project meetings (e.g. Investigator meeting, Kick-off meeting, teleconferences, etc.).
• Attends data review meetings (interim analysis and final data analysis), as indicated.
• May participate in dose escalation meetings for early phase studies.
• May attend and provide review of documents for DSMB meetings.
• 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.
• Prepares Analysis of Similar Events for expedited safety reports.
• 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 (presented e.g. in the format of listings, patient profiles, visual analytic templates, etc.), as per the MMP/Medical data review plan for clarifying and resolving data inconsistencies, query management, trend assessment, etc.
• May perform Medical review of coding to ensure correct MedDRA/WHODrug coding.
• May review requests from Regulatory Authorities and/or Ethic Committees/IRBs and related activities with preparation of responses, when requested.
• Ensures appropriate safety considerations have been incorporated into the Clinical Event Committee (CEC) process, if requested.
• Escalates issues and notifies Line Manager, Project Manager, and/or other responsible staff if urgent safety issues are identified.
• Provides availability (to sites, Sponsors, project teams) via call-in number up to 24 hours / 7 days a week or other schedule, as needed.
• Documents all communication (interactions with sites, Sponsor, etc.) and provides for filing in the TMF, as required.
• 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.
• Other tasks and responsibilities, as requested.
• * Business Development Support (as needed):
• Supports Business Development by preparing protocol considerations for new Proposals, answering Requests for Information, etc., as requested.
• Attends capability and bid defense meetings, as needed, to provide medical and scientific advice for potential new projects.
• May attend professional meetings, serve as a speaker, and/or assist with Business Development efforts.
• 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: Medical Director may act as Line Manager, if indicated. In case more than two Medical Monitors are assigned to the project, one MM may by Primary MM, assuming more responsibilities e.g. communication with the Client and other functions. Details of the split of responsibilities are described in the MMP.
• MD (or country-specific equivalent) required, postgraduate training/eligibility for licensure preferred.
• At least 5-10 years of experience research experience post-training. Clinical Research Organization (CRO) experience is strongly preferred.
• Must have prior Oncology experience.
• Prior experience across the spectrum of Medical Monitoring activities, including Medical review of safety information.
• Prior experience working in multiple therapeutic areas and across Phase 1 to 3 clinical trials is preferred.
• 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.
• 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.
• Effective communication: comfortable communicating both inside and outside to company.
• Management with a calm, positive winning attitude and excellent decision making skills.
• 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 Guidances.
• Training expertise: able to efficiently train others.
• People management: able to clearly and efficiently communicate with site and team members.
• Clinical Management: able to manage clinical projects successfully.
• Time management: good sense of urgency, prioritization skills.
• Team player: effective participant as a team member and team leader.
• Creative and positive leadership: programming team success through establishing and clear articulation of goals.
• Creative problem solving skills.
• Effective oral and written communication and presentation skills (at least in English) are compulsory.
• Coach: a passion to assist others in becoming all they can be; Achievements: ability to define and meet requirements.
• Integrity: Understanding and acting on principles of honesty, trust and fairness.
• Proficient in the use of computers and Microsoft Office applications.
• Ability to drive an automobile and have a valid driver’s license.
• Ability to travel by airplane.
• Must have a credit card that can be used for travel expenses.
• Ability to work remotely.
• Ability to travel up to 20%, as needed.
The company will not accept unsolicited resumes from third party vendors.
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