Clinical Trial Liaison, North America

Associate/Director, Clinical Trial Liaison

Reports to Senior Director, Clinical Development & Medical Affairs

Opportunity

This role is pivotal in supporting the successful execution of breast cancer clinical trials at Menarini Stemline. The CTL will achieve this by fostering robust relationships with clinical trial sites and investigators, with a key focus on optimizing patient enrolment. Collaboration is central to this role, working closely with the clinical trial sites and the cross-functional teams including Clinical Research Associates (CRAs), Field Medical affairs team, Project Managers, and Medical Monitors, all under the guidance of a Senior Director in the clinical development team.

Responsibilities

1. Site Identification and feasibility support:

• The CTL will be responsible for identifying potential clinical trial sites and investigators who specialize in breast cancer. This identification process will be guided by study protocols, inclusion/exclusion criteria, and input from the Clinical Development team.
• A thorough evaluation of site capabilities, patient populations, and referral networks is necessary to determine the feasibility and suitability of each site for participation in breast cancer studies.

1. Recruitment Support:

• Collaboration with sites is essential to develop and implement effective patient recruitment strategies tailored specifically for breast cancer studies. These strategies should consider patient demographics, tumor characteristics, and the current treatment landscape.
• The CTL will provide guidance and support to sites on recruitment challenges and best practices, drawing on their knowledge of breast cancer patient advocacy groups, support organizations, and relevant medical conferences.
• Monitoring site enrolment progress is crucial to identify potential roadblocks and proactively address them. This will involve working in partnership with the study team.

1. Relationship Management:

• Building and maintaining strong relationships with investigators, site staff, and key opinion leaders in the field of breast cancer is a critical aspect of this role.
• The CTL will serve as the primary point of contact for site inquiries related to recruitment and enrolment in breast cancer studies. They are expected to provide timely and accurate information to maintain clear communication.
• Facilitating communication and collaboration between sites and the study team is another vital responsibility, ensuring that everyone is aligned on recruitment goals and strategies.

1. Study Conduct Support:

• The CTL will support site initiation activities, including training on recruitment procedures specifically designed for breast cancer and providing relevant study materials.
• Collaboration with CRAs is necessary to ensure the smooth conduct of the study and to address any recruitment-related challenges that may arise in breast cancer trials.
• Any site concerns or issues that arise need to be escalated to the Clinical Development team and Senior Director for timely resolution.

1. Scientific Communication:

• Delivering accurate and up-to-date information about the company's breast cancer pipeline products to healthcare professionals is a key responsibility. This may be achieved through one-on-one meetings, presentations, and scientific exchanges.
• Medical Insights Gathering: Actively collecting insights from healthcare professionals regarding the study protocol, site specific requirements and breast cancer treatment landscape is essential. These insights will inform the company's research and development strategy.

1. Compliance and Training:

• Maintaining a comprehensive understanding of relevant regulations, GCP, and ICH guidelines related to clinical trial conduct and patient recruitment is crucial. Particular emphasis should be placed on regulations pertaining to breast cancer research.
• The CTL must ensure that all recruitment activities are conducted ethically and in compliance with applicable laws and regulations.
• Ongoing participation in training is encouraged to enhance knowledge of breast cancer research, treatment advances, and best practices in patient recruitment.

Skill/Knowledge Requirements

• A Bachelor's degree in a scientific or healthcare-related field is required, while an advanced degree (e.g., DNP, MD, PharmD, PhD) is preferred.
• A minimum of 3 years of experience in clinical research, with a strong focus on breast cancer clinical trials, is required.
• Candidates should also have experience in site management, monitoring, or recruitment.
• An in-depth knowledge of breast cancer is crucial, including an understanding of disease subtypes, staging, treatment options, and the current research landscape.
• A strong understanding of clinical trial operations, GCP, and ICH guidelines is also required.
• Excellent communication, interpersonal, and presentation skills are essential, along with the ability to explain complex scientific concepts clearly.
• A proven track record of building strong relationships with healthcare professionals and key stakeholders is essential for this role.
• Strong organizational and time management skills are required, with the ability to prioritize tasks effectively.
• The candidate must be able to work independently and as part of a team.
• A willingness to travel up to 60% of the time is required.

NOTE: Role is remote based, with expectations for business travel and onsite presence approx. 25%

Stemline Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.