JOB SUMMARY:
The Clinical Evidence Manager is responsible for generating and gathering clinical evidence for China for both the orthodontic and general dental channel. Specifics would include reviewing literature and providing summaries for the sales and marketing teams to use clinical evidence gap analysis, publication and whitepaper planning, reviewing marketing materials and uation of doctor sponsored studies. This position serves as the global and APAC clinical evidence liaison with cross-functional stakeholders in the region as well with the global and APAC teams. Major deliverables are reviewed to ensure clinical, business, and regulatory requirements are met.
The Clinical Evidence Manager will also maintain a diverse portfolio of strategic clinical relationships, such as the advisory board and KOL groups, encouraging interest, study, support, and acceptance of Align’s technology and products in the market place for existing and potential applications. A key part of this role will also be to develop influential market messaging from the clinical data and drive distillation messages to key stakeholders.
JOB DEION:
•Leads development of assigned evidence strategies for the business. This includes interfacing with representatives from key functional groups including Quality, Regulatory Affairs, Marketing, Clinical Education, Clinical, Legal, International Clinical Research Groups, and Product Development (as needed).
•Collaborate with marketing on building an influential clinical evidence plan to help clinicians understand, accept and recommend Invisalign – including differentiation among brands.
•Cultivate collaborative relationships with current and future thought leaders in academic and clinical practice at the local, regional and national level.
•Develop the foundational data for medical and scientific marketing/product material including promotional pieces, technical sales aids, etc., in conjunction with the marketing team.
•Advise on dental and scientific marketing/product material in conjunction with marketing. Provide clinical and customer input to internal teams as it related to the use of our products and positioning with key customer groups.
•Define and facilitate the initiation, execution, authoring, and publication of clinical projects, collaborating with the clinical studies group on execution and reporting for Align-sponsored studies.
•Provides project management and assures successful conduct of assigned projects.
•Facilitates Publication plans for assigned studies. Works with Doctors and Research Investigators to ensure accurate study publications. Works internally to obtain input on the Publication Plan and updates regularly to address evidence gaps.
•Work with investigators to quickly and effectively resolve problems.
•Develop clinical evidence report, lead cross-functional gap analysis, and propose future strategy and communicate.
•Conduct scientific literature review for regulatory compliance purposes, per SOP.
•Prepare literature review and bibliography as requested
•Lead Advisory Boards preparation including initiating meeting requests to doctors, assigning session note takers, and compiling report out information.
•Provide clinical review of marketing communication materials per standard operating procedures.
•Provide input and support for launch, education, and marketing of products.
•uate external research proposals for scientific soundness. Ensure compliance to milestone based payment through receipt of reports and approved deliverables.
QUALIFICATIONS
EDUCATION AND EXPERIENCE
•DMD or DDS degree
•Masters degree or a certificate in orthodontics or prosthodontics is an added advantage
•Experience in technical writing such as clinical study plans, clinical reports, scientific manus, clinical evidence reports.
•Experience in assessing medical evidence
•Experience in publication planning
•Familiarity with Good Publication Practices
•Familiarity with KOL mapping and advisory boards
•Strong critical thinking and analytical skills with proficiency in managing multiple tasks
•Demonstrated ability to identify issues and implement solutions, including identifying and involving the appropriate decision makers
•Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
•High attention to detail and accuracy
•Working experience with clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and industry guidelines for devices
•Proven track record of delivering results, high initiative and strong organization skills
•Strong interpersonal skills including communication, collaboration and negotiation capabilities
•Effective oral and written communication with dental professionals, scientists, peers, and senior management
•Ability to independently set and manage multiple competing priorities while guiding others
•Ability to travel, including internationally approximately 20-50% of the time
SKILLS REQUIRED
•Fluent in English
•Expert in PowerPoint, Excel, Word, and overall computer skills
