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In this position the Clinical Trial Manager will play a key role in supporting the design, managing the implementation and conduct of the next stage of state-of-the-art clinical utility prospective multi center trial(s) and registries across a number of continents that may help change the standard of care and improve patient outcomes in transplantation. The candidate will provide direction and operational leadership of the clinical research studies to ensure delivery on time, within budget, and of high-quality in compliance with ICH GCP, Internal SOPs and all other applicable regulations. The Clinical Trial Manager should be a critical thinker and capable of problem solving and aligning the priorities with study outcomes and timelines as well as be proactive and unafraid to get their hands dirty. A good candidate should demonstrate clinical development experience of the operational aspects of all stages of clinical studies preferably working in and/or monitoring or leading affiliate teams, working with vendors and/or CROs, study supply management and planning operational activities to achieve database lock. A knowledge of molecular diagnostics and regulation associated with this space across multiple continents is an essential component of this role.
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Headquartered in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant recipients. Our client offers products along the pre- and post-transplant testing continuum. The medical director will be an MD trained in transplantation, and will lead the effort to educate and support the commercialization strategy of Client’s products through the development of clinical trials, studies and national and international registries. The responsibility of this position is to educate and partner with clinical and business leaders including transplant nephrologists, cardiologists and governmental health ministers, and laboratory directors, distributors. The medical director will partner with the regional technical and business leads in EMEA, Americas and APAC to help prioritize, analyze, propose and execute clinical and business partnerships that will enable widespread clinical uptake. You will have the opportunity to launch and scale Client’s new best-in-class NGS products, as well as, drive the data using this platform to show improve outcomes for solid organ transplant recipients. The role is within the medical affairs organization and a broad Client team will support the medical director’s success, including Research & Development, Marketing, Medical Affairs, Regulatory and Finance. The ideal candidate has experience developing clinical messaging and influencing clinicians and transplant key opinion leaders to drive uptake in transplantation management. A record of accomplishments in transplantation, deep clinical knowledge and ability to build senior client relationships, and/or launching new products in an entrepreneurial environment is a strong plus. The position involves frequent travel across the country, working with key transplant centers across the nation and supporting the MSL team with senior medical leadership where needed.
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Clinical Trial Manager In this position the Clinical Trial Manager will play a key role in supporting the design, managing the implementation and conduct of the next stage of state-of-the-art clinical utility prospective multicenter trial(s) and registries that may help change the standard of care and improve patient outcomes in transplantation. The candidate will provide direction and operational leadership of the clinical research studies to ensure delivery on time, within budget, and of high-quality in compliance with ICH GCP, Internal SOPs and all other applicable regulations. The Clinical Trial Manager will supervise and help develop a sub team of clinical research associates. The Clinical Trial Manager should be a critical thinker and capable of problem solving and aligning the priorities with study outcomes and timelines. A good candidate should demonstrate clinical development experience of the operational aspects of all stages of clinical studies preferably working in and/or monitoring or leading affiliate teams, working with vendors and/or CROs, study supply management and planning operational activities to achieve database lock. A knowledge of molecular diagnostics and regulation associated with this space would be a plus.
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Program: Clinical Education Liaisons Department: Immunoscience Reports To: CEL Field Manager (NFM) Location: Field Territory: San Francisco Title: Clinical Education Liaison (CEL) The Clinical Education Liaison will represent client and its approved rheumatology product.The CEL will be aligned with the client field medical function, working closely with the client field commercial and Medical teams, and responsible for interacting with a targeted and CEL identified list of external HCPs in a defined territory. The CEL will be primarily responsible for conducting presentations to HCPs (in 1:1 or group settings) of approved efficacy and safety information. In addition, the field medical staff will respond to scientific exchange in specifically defined disease and investigational compounds or research areas if applicable.
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Program: Clinical Education Liaisons Department: Immunoscience Reports To: CEL Field Manager (NFM) Location: Field Territory: Kansas City, MO Title: Clinical Education Liaison (CEL) The Clinical Education Liaison will represent client and its approved rheumatology product.The CEL will be aligned with the client field medical function, working closely with the client field commercial and Medical teams, and responsible for interacting with a targeted and CEL identified list of external HCPs in a defined territory. The CEL will be primarily responsible for conducting presentations to HCPs (in 1:1 or group settings) of approved efficacy and safety information. In addition, the field medical staff will respond to scientific exchange in specifically defined disease and investigational compounds or research areas if applicable.
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Program: Clinical Education Liaisons Department: Immunoscience Reports To: CEL Field Manager (NFM) Location: Field Territory: GA / Carolinas Title: Clinical Education Liaison (CEL) The Clinical Education Liaison will represent client and its approved rheumatology product.The CEL will be aligned with the client field medical function, working closely with the client field commercial and Medical teams, and responsible for interacting with a targeted and CEL identified list of external HCPs in a defined territory. The CEL will be primarily responsible for conducting presentations to HCPs (in 1:1 or group settings) of approved efficacy and safety information. In addition, the field medical staff will respond to scientific exchange in specifically defined disease and investigational compounds or research areas if applicable.
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- The Medical Science Liaison will represent client and its approved products in Transplant/Immunology.- The MSL will be aligned with the client field medical function, working closely with the field, commercial and Medical teams, and responsible for interacting with a targeted and MSL identified list of external HCPs in a defined territory. The MSL will be primarily responsible for conducting presentations to HCPs (in 1:1 or group settings) of approved efficacy and safety information. In addition, the field medical staff will respond to scientific exchange in specifically defined disease and investigational compounds or research areas if applicable.
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- The Medical Science Liaison will represent client and its approved products in Transplant/Immunology.- The MSL will be aligned with the client field medical function, working closely with the field, commercial and Medical teams, and responsible for interacting with a targeted and MSL identified list of external HCPs in a defined territory. The MSL will be primarily responsible for conducting presentations to HCPs (in 1:1 or group settings) of approved efficacy and safety information. In addition, the field medical staff will respond to scientific exchange in specifically defined disease and investigational compounds or research areas if applicable.
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- The Medical Science Liaison will represent client and its approved products in Transplant/Immunology.- The MSL will be aligned with the client field medical function, working closely with the field, commercial and Medical teams, and responsible for interacting with a targeted and MSL identified list of external HCPs in a defined territory. The MSL will be primarily responsible for conducting presentations to HCPs (in 1:1 or group settings) of approved efficacy and safety information. In addition, the field medical staff will respond to scientific exchange in specifically defined disease and investigational compounds or research areas if applicable.
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- The Medical Science Liaison will represent client and its approved products in Transplant/Immunology.- The MSL will be aligned with the client field medical function, working closely with the field, commercial and Medical teams, and responsible for interacting with a targeted and MSL identified list of external HCPs in a defined territory. The MSL will be primarily responsible for conducting presentations to HCPs (in 1:1 or group settings) of approved efficacy and safety information. In addition, the field medical staff will respond to scientific exchange in specifically defined disease and investigational compounds or research areas if applicable.
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Our client is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Our client recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. This role is director level. CV, metabolic, or pulmonary experience is preferred.
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The Regional Medical Science & Operations Liaison will represent the Client Cardiovascular Field Medical organization, as assigned. The RMSOL will be aligned with the Client Field Medical function, working closely with the Client Field Commercial, Field Health Economics Outcomes and Home office Medical teams, with direct responsiblility for interacting with a targeted and additional identified list of external HCPs in a defined regional geography. The RMSOL will be primarily responsible for conducting presentations to HCPs (in 1:1 or group settings), communicating approved efficacy and safety information. As a member of the field medical team, the RMSOL will be responsible for scientific engagement of HCPs around defined disease areas, research topics and/or investigational compounds, as applicable. In addition, the RMSOL will provide operational support to the Cardiovascular Field Medical team.
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The Cardiovascular Medical Science Liaison (MSL) is responsible for identifying disease and product related medical needs in a defined geography.
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Director, Medical Science Liaison – NortheastThe territory will include: New York, New Jersey, Washington DC, Massachusetts, Connecticut or Pennsylvania.This is an individual contributor position expected to perform at a director level.Therapeutic area - Allergy/Respiratory/Pulmonology.
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The Cardiovascular Medical Science Liaison (MSL) is responsible for identifying disease and product related medical needs in a defined geography.
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Medical Science Liaison- New YorkThe Medical Science Liaison (MSL) will apply his/her background in transplant patient care and use of laboratory tests in patient management to educate physicians and transplant coordinators about the clinical value of the client’s tests as non-invasive methods to monitor transplant recipients for organ rejection. The MSL will be familiar with current best practices of post-transplant patient management and will explain how diagnostic tests are useful in patient care. Excellent communication skills are essential for the MSL who will operate from a home-based office. Significant travel is required to visit transplant clinics affiliated with teaching hospitals located in the region.