Serving as a value, added, field-based resource, and extension of Company's Medical Affairs team, the Clinical Trial Liaison (CTL) will play a crucial role in the execution of clinical trials. In this pivotal position, the CTL will provide essential support to Company's Global Clinical Sciences and Operations teams, contributing significantly to the success of their clinical research initiatives, specifically to the success of the phase III program, evaluating the safety and efficacy of company's asset.
Duties and Responsibilities:- Drive awareness and enrollment of patients, ensuring that they provide the investigators and site staff with relevant, compliant, and consistent medical and scientific support and communications Provide in-depth drug and disease state medical and scientific information to HCPs.
- Conduct targeted conversations with the investigators and site staff regarding operational challenges, including but not limited to those related to patient recruitment and retention.
- Actively participate in supporting and driving recruitment and enrollment with sites in collaboration with Clinical Operations and CRO teams.
- Maintain clinical, scientific, and technical expertise in relevant rare hematology disorders with a focus on chronic neutropenia.
- Engage with investigators and other site personnel at sites to ensure they are familiar with all protocol and patient information as well as serve as a local clinical expert and support clinical operations efforts.
- Identify and recommend new sites for consideration for trial participation. Support feasibility, site selection and present scientific and medical disease background, protocol and other study/disease relevant material at the site initiation visits (SIVs)
- Identify barriers to clinical trial environment and recommend solutions to overcome these barriers and contribute to study recruitment strategy
- Provide medical/clinical teams with feedback and insights from interactions with KOLs and investigators pertaining to trial and other scientific narratives
- Additionally, the CTL may also participate in and contribute to projects and initiatives that increase the value and productivity of the Medical Affairs team
- Represent the company at medical meetings through Medical Affairs' Scientific Booth and sessions/posters/CI coverage and other related activities
- Other duties/responsibilities as assigned
Qualifications: - Advanced degree (PharmD, PhD, MD, NP, PA) or equivalent terminal degree with appropriate clinical experience and scientific background required
- Prior experience as an MSL/CTL (3-5 years); preferably with a clinical trial focus in a pre-launch setting required
- Prior Rare disease and/or immunology and/or hematology experience preferred
- Proven ability to engage Investigators/KOLs in non-promotional, scientific exchange
- Prior clinical operations, site level trial execution, and CRO experience preferred
- Ability to travel, locally and regionally, up to 50% with overnight stays (car, plane, train)
- Knowledge of local regulatory requirements and Pharmaceutical Association Codes, including regulations governing compliant scientific exchange
- Demonstrated ability to integrate and work in cross functional network/matrix
- Demonstrated project management ability
- Excellent communication (oral and written) and interpersonal skills
- Must be able to proficiently communicate (oral and written) in English and other languages required by region
- Valid driver's license
