Clinical Trial Liaison
The Clinical Science Liaison (CTL) will serve as a value added resource to sites and investigators and to support the Company’s Clinical Development Programs. The CTL will be responsible for building and managing relationships with, Key Opinion Leaders (KOLs), clinical trial investigators and research staff to ensure full engagement throughout the course of the study. They will also work to build relationships, where appropriate, with patients groups, scientific organizations, and advocacy organizations.
Being regionally based, the primary focus for the CTL role will be to enhance clinical trial execution and enrollment through building deep relationships with study investigators and research staff in their region. The CTL will work with the clinical investigators and site staff to provide education, support enrollment and retention initiatives, identify mitigate and provide solutions to enrollment hurdles, disseminate product/trial information, represent company interests and provide scientific intelligence.
Territories for the CTL position will vary as needs arise and develop. There will be approximately 6 CTL positions located across US, Europe, and Asia-pacific regions.
Duties and Responsibilities
The incumbent will hold a strong background in clinical research, able to understand protocols, study conduct, and drug development. A background in neuroscience, including neurogenic orthostatic hypotension or autonomic dysfunction and/or cardiovascular disease such as chronic heart failure or hypertension is strongly desired. Additional experience in the gastroenterology space is also desired, particularly with inflammatory bowel disease.
Key Accountabilities / Responsibilities:
- Builds and cultivates relationships with disease area experts (KOLs), Clinical Investigators in the disease area, Research sites and staff and institutions
- Works aggressively with sites, investigators, disease area experts (KOLs) and cross functional team members to ensure the rapid and successful enrollment and completion of the clinical trial program. This will be the primary measure by which the success of this position will be assessed.
- Proactively identify issues and barriers to enrollment and work to develop solutions in a cross functional manner
- Proactively identify and address concerns from sites and patients regarding clinical trial participation
- Works cross functionally within Theravance, including Operations, Clinical Development, Medical Affairs, Regulatory, Safety and others to facilitate the conduct and successful completion of clinical trials.
- Serve as a resource to provide education as warranted on clinical trial protocols, scientific background related to product, research rationale and latest information related to relevant clinical research.
- Provide medical / scientific training and a support function for key internal stakeholders, including development and or review of training materials for clinical trials, products in development, associated therapeutic areas, and disease state
- Sustains expertise in disease state management, emerging therapies, and the competitive landscape
- Attend relevant national, regional and international meetings in the relevant therapeutic area, serving to gather information on developments in the therapeutic area, and to represent the company as required.
- Engage in peer-to peer discussions with investigators and researchers about trial progress, data and results.Ensure that developing safety information is rapidly distributed to sites, investigators, and experts to ensure the safety of all patients enrolled, or considering enrollment, in the clinical trial.Provide support to investigator's requests for investigator-initiated studies according to company guidelines.
- Work with the Medical Science Liaison Team (MSL’s) to establish and maintain relationships with current and future thought leaders participating in the relevant therapeutic area by engaging in discussions related to scientific and/or publication concepts.
- Ensure a smooth transition of the program / product to the MSL team upon completion of the clinical development program, including possible transition to the MSL as a product / therapeutic expert.
Minimum Education and Experience:
- Advanced scientific or clinical degree (Pharm D., Ph.D., MD, and other associated HCPs)
- 5 years working in clinical research, either at a site or in the biotech industry. Experience as an MSL is also acceptable.
- Ability to manage a geographically assigned territory from a home based office
- Able to travel at least 70%, including international travel
- Valid driver’s license / passport as required by region
Preferred Education and Experience:
- Knowledge or experience in the neuroscience therapeutic area, including neurogenic orthostatic hypotension or autonomic dysfunction and/or cardiovascular disease such as chronic heart failure or hypertension
- Experience in clinical trial design, logistics, and evaluation
- Knowledge of compliance and regulatory requirements in clinical trials and drug development
Preferred Knowledge, Skills, and Abilities:
- Excellent interpersonal skills, particularly the ability to start and build deep and lasting relationships with key stakeholder
- Effective written and verbal communication skills; including scientific and medical information to a diverse audience of both internal and external personnel in small and large audience setting
- Exhibits high motivation and high energy level, self-starter
- Ability to work independently and adjusts effectively to work within new processes or requirements
- Passion for teamwork; proven performance in cross functional team environments
- Demonstrate strategic thinking and strong geographical management skills
- Ability to effectively present complex data and strategy to large groups
- Skilled at taking strategic initiatives and translating them into tactical solutions
The incumbent will spend a considerable amount of time traveling, looking at a computer monitor and typing.