Senior Director, Medical Monitor
Remote
Full Time
Senior Manager/Supervisor
Objective
The Senior Director, Medical Monitor, will play a critical role in overseeing the medical and scientific aspects of clinical trials from pre-clinical through phase 1-4 development. This role requires a deep understanding of oncology and the ability to work cross-functionally with clinical operations, regulatory affairs, translational oncology, biostatistics and other departments to ensure the successful conception, start-up and execution of clinical trials including careful monitoring of clinical data. The ideal candidate will have a proven track record in oncology clinical development that includes experiences with regulatory interaction and submission, a comprehensive understanding of the drug development process and a familiarity with radiopharmaceuticals. This role is critical in guiding the development of innovative cancer therapies from the conception of their place in the therapeutic landscape through regulatory approval and reimbursement. This individual will provide strategic leadership in this process across line functions driving the company’s mission and competitive edge.Essential Functions
Clinical Trial Oversight
- Provide medical and scientific leadership and oversight for all phases of clinical trials (pre-clinical to phase 1-4) related to radiopharmaceutical products in oncology.
- Monitor patient safety, therapeutic efficacy and the integrity of all clinical trial data, including the review of adverse events, serious adverse events, and safety-related information.
- Ensure that clinical trials are conducted in accord with the highest ethical standards and in compliance with all relevant regulations and guidelines.
Medical Leadership and Support
- Serve as the primary medical contact for clinical trial sites, addressing any medical concerns or questions from investigators and study staff.
- Mentor and provide guidance to junior medical monitors and other clinical development team members.
Collaboration and Cross-Functional Coordination
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, translational oncology and biostatistics, to ensure the smooth design and execution of clinical trials.
- Participate in the design, development, and review of clinical trial protocols, informed consent forms, and other essential study documents.
Regulatory and Strategic Contributions
- Contribute to the development and submission of regulatory documents, including Investigational New Drug (IND) applications, Clinical Study Reports (CSRs), and New Drug Applications (NDAs).
- Lead and contribute to the analysis, interpretation, and presentation of clinical trial data.
Continuous Learning and Innovation
- Stay current with advances in oncology, clinical management / standards of care, radiopharmaceuticals, and clinical research methodologies.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education/Experience
- Medical Doctor (MD) degree from an accredited medical school required. Board certification in oncology preferred.
- 3-5+ years of clinical practice experience in the relevant therapeutic area, with a focus on oncology or nuclear medicine preferred.
- 2+ years of industry experience in clinical development, including hands-on involvement with early to late-phase clinical trials (Phase I-IV).
- Experience in the preparation and review of clinical trial documents, including protocols, informed consent forms, and regulatory submissions.
- Experience in medical monitoring and ensuring the safety of study participants during clinical trials is highly desirable.
Knowledge / Skill / Ability
- Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
- Outstanding leadership, collaboration, and teamwork in a cross-functional setting; comfortable with a hands-on leadership position.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in a cross-functional team environment.
- Strong analytical and problem-solving skills, with a keen attention to detail.
- Ability to manage multiple projects simultaneously and prioritize tasks effectively.
- Must be willing to travel up to 20% of the time. Both domestic and international travel may be required.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.- Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
- May be required to sit or stand for long periods of 8+ hours a day while performing duties.
- Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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