Join Amplity, the full-service go-to partner of biopharma companies that delivers flexible + specialized medical + commercial services. No matter where a drug is in its lifecycle, we scale with ease to maximize resources + improve impact for all our clients. Through strategic partnerships + deep therapeutic expertise, Amplity transforms how breakthrough treatments reach the people who need them.
Business Unit: Medical Affairs
Reports to: Field Manager, Amplity
Location: Anywhere in Brazil
Territory: Brazil and Argentina
Individual Contributor or Manager: Individual
What you’ll be doing:
This role is pivotal in supporting the successful execution of breast cancer clinical trials. 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.
What your day-to-day responsibilities will be:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
What you’ll need to be successful:- An advanced doctoral degree (MD, PHD, Pharm D) is preferred
- Fluency in English and local language
- 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.
- A strong understanding of clinical trial operations, GCP, and ICH guidelines is also required.
- Ability to effectively communicate and assimilate scientific and clinical data to the relevant audience
- Demonstrable experience in building and maintaining relationships with KOLs
- Willing and able to travel internationally, up to ~60% of time
About UsAmplity powers biopharma innovation through expert-led teams that deliver. Whether you knew us in the 80’s as Physician Detailing Inc., or in the 00’s as part of Publicis Health, the companies that came together in 2019 to form Amplity have delivered contract medical, commercial + communications excellence for 40+ years.
Our people-driven, tech-enabled DNA fuels everything we do. Our professionals understand the pharmaceutical industry from the inside out. With a deep grasp on product lifecycles, marketing hurdles, operational nuances + the complex needs of providers and patients, we help our clients launch products + operate smoothly with precision - across all business shapes, sizes + specialties.
We are on a mission to improve patient outcomes through executional excellence - enabling our partners in pharma to thrive in turn. At Amplity, we are allies in excellence. And we do it quicker, better, nicer than anyone else.
Our Diversity PolicyWe encourage and support equal employment opportunities for all associates and applicants for employment without regard to sex, race, color, religion, national origin, age, disability, marital status, sexual orientation or veteran status. Employment decisions are evaluated on the basis of an individual's skills, knowledge, abilities, job performance and other qualifications. In addition, Amplity Health maintains policies and procedures designed to comply with applicable federal, state and local laws governing non-discrimination in employment in every location in which Amplity Health has facilities.