Description
Job Title: Surgical Device/Medical Science Liaison
Job Location: South San Francisco, CA
Job Duration: 12 months Position Overview The Surgical Device Liaison will be a member of an outstanding technical team and be the primary conduit for surgical technical information to and from the clinical environment including the operating room and clinic. The Surgical Device Liaison will be responsible for all aspects of Investigator and clinical staff training, certification and product device technical support to ensure optimal patient outcomes. The Surgical Device Liaison may contribute to clinical development programs on multiple levels as an integral member. The Surgical Device Liaison is a credible scientific partner who as needed will be responsible for providing clinical information related to disease states and the appropriate utilization of *** medicines (approved and pipeline).
Key Responsibilities/Accountabilities
In this position, you will be primarily accountable to consistently and effectively:
" Provide master level device and surgical training, education and ongoing support to investigators and clinical staff on the use and application of Port Delivery System (PDS) technology to the highest ethical and professional standards and in accordance with guidelines and direction.
" Work with company and clinical sites to support clinical trials involving Roche drug delivery device(s).
" Work with engineering, clinical and device teams to develop quality resources and knowledge assessment tools for the training of physicians and clinical support staff.
" Collect and internally communicate technical surgical information and feedback from clinical investigators.
" Continuously increase knowledge of new developments within the assigned market as well as company developments in order to function as a subject matter expert.
" Ability to travel 70-80% of the time (may be 3-4 days/week within US)
Operational activities: " Support and instruct the Investigator, operating room and clinical staff through in-person Operating Room attendance at implant, refill-exchange and explant procedures for the surgical device.
" Provide remote and on-site support and training of surgical staff during the use of the device/system.
" Prepare and communicate to manager on a timely and regular basis:
o Summary of field activities.
o Input on travel, budget and other resource requirements.
" Manage travel schedule and remote support capabilities
" Identify needs as they arise, propose solutions and complete special projects.
Strategy/Planning: " Build and cultivate important working relationships:
o Externally with assigned clinical sites and staff in order to support Phase I, II, III & IIIb studies
o Internally, with cross-functional partners, such as Medical Science Liaisons, Product Development, Clinical Operations, Device Development, Research and Early Development teams, or other Medical Affairs groups.
" Evaluate, review and propose revisions to protocols in support of the development of the assigned drug delivery device(s).
" Serve as the technical expert of site feasibility assessment for clinical trials involving the assigned drug delivery device(s)
Qualifications: Advanced Clinical/Science Degree preferred (e.g., MD, PharmD, PhD, MSN, NP, PA etc.). BSN, COA, COT and COMT with extensive clinical and industry experience may be considered. Previous industry based Surgical/MSL experience is preferred.
Knowledge
" Be proficient in GCP (Good Clinical Practice), Adverse Event reporting and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
" Able to interact professionally and effectively with customers, physicians, nurses and other medical staff
" Familiarity with managed care, health economics, healthcare reimbursement and the distribution channels relevant to pharmaceutical/biotechnology organizations
Required Experience Minimum of 5 years related work experience (surgical and/or clinical setting or industry experience)
Prior experience in an ophthalmic Surgical setting is preferred
2 years of Ophthalmology therapeutic area experience (either in industry or another related setting) is preferred
Skills " Outstanding ability and desire to teach, demonstrated by possessing self-confidence and effectiveness with a wide variety of student types
" Maintain all necessary certifications and hospital vendor credentialing including, but not limited to:
o HIPAA Certification
o Blood Borne pathogen
o Infection Control and Aseptic Technique
o Fire Safety
o Individual Institutional Requirements
" Able to interact professionally and effectively with customers, physicians, nurses and other medical staff
" Able to work independently from a remote environment
" Excellent attention to detail, possessing good organizational and time management skills
" Computer skills necessary to generate reports, presentations, spreadsheets, etc.
" Ability to communicate clearly and concisely in written and verbal communications
" Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing objectives, goals and other priorities to effective and efficient conclusion
" Proven track record of meeting or exceeding objectives and goals
" Learning mindset, open to training and becoming an expert across customer types or multiple therapeutic areas
" Highly motivated and flexible team player with focus on the success of oth
