Clinical Science Liaison, East
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Clinical Science Liaison, East Position Summary
The Clinical Science Liaison (CSL) will foster relationships with clinical investigators, other professionals at the site level, as well as other physicians/institutions experienced in the treatment of the disease of interest (potential investigators or referring physicians) to optimize patient recruitment and retention for clinical trials. The primary focus will be those in the field of Lysosomal Disorders with an emphasis on those with Pompe Disease. The CSL will have a thorough understanding of the Amicus program as a whole, including disease of interest, investigational agent(s) being used in the study, the preclinical and clinical data for these agent(s), the trial's eligibility criteria, and all aspects of the study design and procedures. In addition, the CSL will work with sites to optimize their performance in the clinical trials and collaborate closely with Amicus clinical operations employees. CSLs will engage and strategize with the sites to support patient recruitment and retention, increase data quality, and address specific issues directly with the investigators and site personnel. The CSL will have a thorough understanding of disease treatment centers in their respective region(s). Repeated interactions will be needed over the course of the trial to ensure that the trial remains “top of mind” with investigators and staff. The CSL will function as part of the study team and will interact on a regular basis with other members of the Amicus program team and CRO/vendors as needed. Furthermore, the CSL will serve as liaison with key investigators to help ensure that they receive prompt assistance with any queries and that any concerns they have are promptly transmitted to the Amicus Clinical Operations team and other stakeholders
Roles and Responsibilities
– Possess a thorough understanding of the disease(s) of interest
– Understand the scientific rationale and operational aspects of the Amicus program and respective clinical trials
– Create educational materials to effectively communicate information regarding the Amicus program and respective clinical trials, in support of patient recruitment and retention
– Be able to effectively communicate information regarding the Amicus program and respective clinical trial(s) to other team members, investigators and site staff
– Identify effective and legally compliant method of patient identification
– Accelerate enrollment of patients through referrals and awareness initiatives
– Attend Investigator meetings to provide education and/or training
– Identify all disease treatment centers in their respective region(s) and work to provide recommendations for new study sites
– Provide assistance to disease treatment centers seeking to refer patients to study sites
– Provide detailed reports of interactions with investigators and site staff
– Serve as a therapeutic expert for internal Amicus staff
Requirements:
Requirements
– MD, PharmD, or PhD in Biological Science or related field is highly preferred
Experience and Skills
– Minimum of 3 years in the clinical research environment as a Clinical Science Liaison or Clinical operations role, with investigator/site interactions.
– Experience in rare diseases is highly preferred
– Ability to extract clinical data and create visual presentations of findings to internal and external stakeholders
– Ability work collaboratively in a field-based role with other medical and clinical colleagues in a coordinated and effective way
– Advanced knowledge of Clinical Operations including related operating processes, policies, and regulations
– Knowledge of FDA regulations, PhRMA code, OIG and AACME
– In depth knowledge of US (International) industry rules and guidelines along with medical and clinical terminology knowledge
– Strong business acumen; has working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. research, development, clinical operations, biostatistics, regulatory, commercial, etc.
– Proven planning and organizational skills
– Strong interpersonal skills in developing and maintaining relationships with both internal and external stakeholders
– Thrives in a team environment
– Proven self-starter that implements creative solutions when presented with challenges
– Specific experience working on patient recruitment challenges in the rare disease space is desirable
– Ability to manage a demanding schedule, and adapt and be flexible as needed with evolving priorities
– Clear alignment with Amicus Core Values
Location
This position will be Field Based.
Travel
Ability to travel (>60%), some weekends included.
