Executive Medical Director

Catalyst Clinical Research

231d

About The Position

As the Executive Medical Director you will take accountability for the following functions/activities: Protect subject safety in clinical trials and promote protocol compliance. Product Safety data review and evaluation Medical monitoring Medical strategy in support of proposals, bid defenses and new contract awards. Position Responsibilities/Accountabilities: Perform core medical monitoring activities for assigned studies, which may include: Input into study design, protocol and regulatory approval strategy. Response to inquiries from the sites, regulatory authorities, IRBs/IECs. Write or support the writing of study or safety monitoring plans. Perform the medical review of patient data during the study period and provide input for the clinical study report. Evaluation of patients’ eligibility, interpretation and appropriate management and reporting of patient safety data throughout the lifecycle of the study in accordance with ICH Good Clinical Practice, applicable regulatory guidelines and company standard operating procedures. Medical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects. Review adverse events (AEs), serious adverse events (SAEs) and AEs of Special Interest and participate in safety signal detection activities to identify emergent safety concerns and recommend appropriate action. Protocol deviations review with proposed grading from medical/safety perspective. 24/7 medical consultancy support to investigators and project team. Participation at Kick-off meetings, Investigator meetings and other study related meetings. Additional Medical Data Review, as agreed with the sponsor in the Scope of Work. Training of the project team and investigators on the indication, IMP, and medical aspects of the study. Support Business Development activities, including medical protocol considerations for proposals, help with feasibility assessments, marketing material development, review of proposals/contracts for medical services, and attendance at bid defense meetings. Act as medical advisor to sponsor companies when required. Function as medical representative in client meetings. The role also contributes to the development of Catalyst’s Site network. Provides oncology thought leadership and supports marketing efforts, meeting attendance, presentations. Support Regulatory consulting opportunities including client interactions and assigning appropriate consultants Prepare and review relevant board presentations and reports. Supporting our network of medical monitors including recruitment, hiring and training. Responsibility for medical monitoring budget updates on an ongoing basis per our change management process. Managerial Requirements/ Responsibilities: Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.

Requirements

Doctor of Medicine or equivalent
Two years of oncology medical practice or 5 years of oncology clinical research experience in a medical role.
Board eligible; prefer board certified; medical licensure strongly preferred
Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
Knowledge and experience with global regulatory reporting requirements for safety updates, Adverse Event reporting and other requires Medical and Safety submissions.
Experience with Oncology treatment paths and Standards of Care
Excellent written, oral communication and presentation skills.
Excellent interpersonal and organizational skills with demonstrated attention to detail.
Ability to read, write and speak fluent English.
Ability to build positive, productive client and team member relationships.
Demonstrated management and problem-solving capabilities, strong critical thinking, and analytical skills
Ability to work both in a team and independently
Ability to lead team meetings and teleconferences
Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%.
Proficient with Microsoft Office Suite.
Strong organizational, problem-solving, and analytical skills.
Ability to manage priorities and workflow.
Versatility, flexibility, and a willingness to work within constantly changing priorities.
Proven ability to handle multiple projects and meet deadlines.
Strong interpersonal skills.
Ability to deal effectively with a diversity of individuals at all organizational levels.
Commitment to excellence and high standards.
Creative, flexible, and innovative team player.
Good judgement with the ability to make timely and sound decisions.

Responsibilities

Protect subject safety in clinical trials and promote protocol compliance.
Product Safety data review and evaluation
Medical monitoring
Medical strategy in support of proposals, bid defenses and new contract awards.
Perform core medical monitoring activities for assigned studies
Input into study design, protocol and regulatory approval strategy.
Response to inquiries from the sites, regulatory authorities, IRBs/IECs.
Write or support the writing of study or safety monitoring plans.
Perform the medical review of patient data during the study period and provide input for the clinical study report.
Evaluation of patients’ eligibility, interpretation and appropriate management and reporting of patient safety data throughout the lifecycle of the study in accordance with ICH Good Clinical Practice, applicable regulatory guidelines and company standard operating procedures.
Medical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects.
Review adverse events (AEs), serious adverse events (SAEs) and AEs of Special Interest and participate in safety signal detection activities to identify emergent safety concerns and recommend appropriate action.
Protocol deviations review with proposed grading from medical/safety perspective.
24/7 medical consultancy support to investigators and project team.
Participation at Kick-off meetings, Investigator meetings and other study related meetings.
Additional Medical Data Review, as agreed with the sponsor in the Scope of Work.
Training of the project team and investigators on the indication, IMP, and medical aspects of the study.
Support Business Development activities, including medical protocol considerations for proposals, help with feasibility assessments, marketing material development, review of proposals/contracts for medical services, and attendance at bid defense meetings.
Act as medical advisor to sponsor companies when required.
Function as medical representative in client meetings.
Contributes to the development of Catalyst’s Site network.
Provides oncology thought leadership and supports marketing efforts, meeting attendance, presentations.
Support Regulatory consulting opportunities including client interactions and assigning appropriate consultants
Prepare and review relevant board presentations and reports.
Supporting our network of medical monitors including recruitment, hiring and training.
Responsibility for medical monitoring budget updates on an ongoing basis per our change management process.
Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.