AngioDynamics VP, Clinical Affairs & Healthcare Economics in Marlborough, Massachusetts
The VP, Clinical Affairs and Healthcare Economics is responsible for (1) global management and direction of all clinical strategy and activity for AngioDynamics’ product portfolio; overseeing all clinical trial research for the company which includes coordination, monitoring, interviewing, and clinical trial services as well as leading and developing policies and procedures to maintain the organization's long-term viability; and (2) providing health economics support to facilitate sales growth to expand the Company’s presence and permeation within Hospital networks, provider systems and accountable care organizations. The VP, Clinical Affairs and Healthcare Economics will work as a strategic partner to the Company’s global businesses in developing clinical and economic evidence, commercial value messaging, portfolio analytics, assessment of policy impacts, and development of customer-facing economic tools. This role is also responsible for managing the department that provides support with respect to understanding the reimbursement climate and its potential impact on products, assistance with disseminating product reimbursement and possible constraints, and providing education and guidance for internal stakeholders. Essential Duties and ResponsibilitiesResponsible for all global clinical activities including registries and formal clinical trials for AngioDynamics’ products.Develop, lead and implement clinical development strategy.Responsible for planning and execution of all CRO contracted activities including consulting, monitoring, statistical analysis, etc.Communication in the Organization of all clinical related activities.Posting and maintenance of all relevant clinical activities with the NIH on www.clinicaltrials.gov or other applications as required.Creation, maintenance and management of all department budget related activities in a cost-effective and timely manner.Interfacing with all principal investigators, DSMB members, sub-investigators, study coordinators and other relevant study participants in order to effectively execute clinical activities.Building and leading clinical affairs team as well as managing department staffing needs in order to meet the needs of the organization.Implement and lead clinical strategy development and execution for all products.Develop and implement strategies to gather health economics evidence for products which are relevant in key markets, in order to support local business teams and to promote the growth of the business.Work with Key Opinion Leaders to design or advise on studies intended to create new economic evidence in support of products in the portfolio.Ensure that economic evidence is available to sales reps and is presented in a way which is easy to understand. Ensure that Territory Managers and leaders are properly trained to enable them to be confident in presenting economic arguments.Ensure that Evidence is available in an appropriate form to support applications for reimbursement and/or funding for new and existing products. This requires close working with medical affairs, regulatory, clinical, marketing and new product development teams in key markets.Provide advice to new product development teams and strategic marketing, including estimating the potential economic value of proposed new developments and recommending a price range to ensure cost effectiveness. This will include advice on the type of economic evidence which will be required to demonstrate economic value to customers and/or to obtain reimbursement.Maintain a thorough understanding of sources of funding for products in major markets and monitor key trends which are likely to affect the business in the future - including trends in health technology assessment. Ensure information is disseminated within the business.Participate proactively with business units and global regions to identify data/evidence gaps for each priority product, and design strategies and research studies to fill gaps in order to support market access, reimbursement, and brands strategies.Oversee the implementation of economic models, value messaging, publication, and development of customer-facing economic tools.Build and maintain advanced understanding of US and OUS healthcare market mechanisms, payer and provider trends, health policy, medical technology, and reimbursement trends in order to inform strategic decision making with respect to healthcare economics and clinical research needs.Direct the work of vendors and outside researchers to accomplish the goals of the organization with respect to data sources, research studies, and development of economic models and tools.Work with clinical teams to ensure that appropriate health economic information is collected in the course of clinical research studies.Implement tactical planning activities required to achieve health economics and reimbursement strategic objectives (e.g., preparation of economic and reimbursement dossiers for payer negotiations, new code applications, customer billing guides, and economic models).In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Support Corporate Account (IDN's/GPO's) initiatives and strategies.May perform other duties as assignedSupervisory Responsibilities Regulatory ResponsibilitiesManages in order to ensure compliance with all relevant regulatory/legal requirementsQUALITY SYSTEMS DUTIES AND RESPONSIBILITIESManagement - Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure all employees are trained to do their work and their training is documented
Education & Experience
Bachelors Level of Degree in a relevant field of study.10 years of demonstrated experience in clinical development for the medical device industry.Minimum of 5 years experience managing and leading staff.Experience implementing programs outside of direct reporting relationships.MBA/MPH, Master/PHD or other advanced degree preferred
Proficient in the following computer software applications: Microsoft OfficeDemonstrated leader in developing and leading technical teams working cross-functionally across organizations.Demonstrated ability interfacing with regulatory agencies and internal partners at a strategic level.Demonstrated success building clinical portfolio’s, identifying opportunities and leading CRO management towards launch of new product development.Demonstrated knowledge of U.S. and global healthcare systems including health care financing, reimbursement policies related to the device industry, and technology assessment.Strong communications skills and experience developing interpersonal relationships with internal and external stakeholders across cultures and time zones..Ability to make effective decisions independently and to work in a fast-paced matrix environment with minimal supervision.Strong presentation building skills, including the use of various media elements.Embraces Innovation and Change.Must demonstrate an ability to review, evaluate and create complex documents related to the role.Ability to think tactically and strategically.Participative leadership style.Advanced understanding of and ability to use evidence to support value propositions.Understanding of public and commercial research claims databases and retrospective data analysis methods.Strong analytical and prioritization skills with the ability to manage several projects simultaneously.Ability to understand complex disease states and technical product information.Polished communicator- written documentation and oral presentations/ discussions/ meetingsExceptional interpersonal skills.Strong organizational skills.Strong communication skills (written and verbal).Ability to effectively communicate both internally and externally.Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job:Work safely and follow all OSHA regulations and company safety policies and procedures.For all on-the-job injuries or accidents, must notify manager/supervisor immediately.Exposure to standard office environmentAbility to frequently lift and/or move up to 15 lbs.Ability to occasionally lift and/or move up to 50 lbs.Ability to regularly sit or stand for extended periods of timeThis position requires some travel up to 30% of the time
As an Equal Opportunity / Affirmative Action Employer, AngioDynamics will not discriminate in its employment practices due to an applicant’s race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity or expression, transgender status, age, national origin, marital status, citizenship, physical and mental disability, criminal record, genetic information, predisposition or carrier status, status with respect to receiving public assistance, domestic violence victim status, a disabled, special, recently separated, active duty wartime, campaign badge, Armed Forces service medal veteran, or any other characteristics protected under applicable law. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
Requisition Number: 1658BR
Title: VP, Clinical Affairs & Healthcare Economics
Type of Position: Fulltime-Regular
Location: Marlborough, MA