Clinical Trial Liaison, Global Development Operations
The Clinical Science Liaison (CTL) will serve as a value added resource and extension of Clinical Operations, to support the Company’s Clinical Development Programs. The CTL will be responsible for enhancing, and managing relationships with, Key Opinion Leaders (KOLs), clinical trial investigators and research staff to ensure full engagement throughout the course of the study. The focus will be to enhance clinical trial execution and enrollment through building deep relationships with study investigators and research staff. 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. The territory for this position may include the United States, Europe and Latin America. The delegation of investigators/study sites to the Clinical Trial Liaison based on geographic proximity, demand, availability, deadlines and priorities.
Duties and Responsibilities
The incumbent will hold a strong background in clinical research with background preference in neuroscience, including neurogenic orthostatic hypotension or autonomic dysfunction and/or cardiovascular disease such as chronic heart failure or hypertension. Role includes establishing and enhancing clinical site relations to support the development and clinical operations activities related to the clinical study trials. The Clinical Trial Liaison is also responsible for establishing training processes/materials to help educate and influence our clinical sites to adopt best practices as well as enhance recruitment and retention activities.
Key Accountabilities / Responsibilities:
- Collaborates Clinical Operations and Research in support of Phase I to IV clinical trials, including site identification, assessment, and education of investigators, recruitment/retention initiatives and clinical site meetings (site specific in-services and global investigator meetings)
- Provide disease education as warranted, 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
- Provide field insight to the study teams related to trends, best practices for the identification and recruitment of trial subjects
- Recruitment Initiatives may include:
- Outreach to KOLs, clinical investigators, site staff and referring physicians to develop relationships, support enrollment initiatives and represent clinical study interests
- Prepare and present study information via formal presentations to generate interest for participation in studies or related activities and/or to confirm understanding of a specific protocol.
- Engage site staff and investigators in discussion to understand and report challenges in subject enrollment and retention and offer potential solutions.
- Manages project work related to Development and Clinical Operations activities and effectively collaborate with cross functional partners as assigned by the Manager, including participation in various initiatives related to scientific and strategic objectives; collaborating with other functional teams; and helping to realize departmental work stream efficiencies.
- May also be called upon to engage in peer-to-peer discussions with investigators and researchers about trial data and results.
- May also provide support to investigator's requests for investigator-initiated studies according to company guidelines.
- In conjunction with the Medical Science Liaisons (MSL’s) collaborate to establish and maintain relationships with current and future thought leaders participating in TBPH clinical trials, by engaging in discussions related to scientific and/or publication concepts.
- Collaborates with MSLs prior to responding to site inquiries to ensure focused and balanced clinical and scientific information that supports the appropriate use of Theravance Biopharma products and services while adhering to Theravance Biopharma’s policy on the dissemination of scientific information.
- Primary contact between therapeutic centers and internal depts. (i.e. Clinical Operations and Medical Affairs) with regard to company and investigator sponsored studies ensuring scientific validity and alignment with company’s medical strategy.
Minimum Education and Experience:
- Advanced scientific or clinical degree (Pharm D., Ph.D., NP, MD)
- 5 years working in the biotech / pharmaceutical industry (or appropriate clinical setting) or 2 years working as an MSL.
- Ability to manage a geographically assigned territory from a home based office
- Able to travel at least 70%
- Valid driver’s license
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 FDA compliance and regulatory requirements
Preferred Knowledge, Skills, and Abilities:
- 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 consultation/teamwork; proven performance in team environments
- Demonstrate strategic thinking and strong geographical management skills
- Sets high standard of performance for self and others; able to multitask and prioritize; performance driven
- Ability to effectively present complex data and strategy to large groups.
- Skilled at taking strategic initiatives and translating them into tactical solutions.
- Excellent interpersonal skills
- Exceptional organizational and time management skills are essential
- Ability to integrate and work in cross functional network
The incumbent will spend a considerable amount of time traveling, looking at a computer monitor and typing.