Careers

Current Openings:

Program Director, Clinical Science

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Position Overview

The Program Director is responsible for providing leadership for working groups of member volunteers tasked with delivering regulatory-grade tools and methods that support development, assessment and review of innovative new devices and technologies for patient benefit. A key area of focus is clinical science innovation and may include, early feasibility studies, coordinated registries network (CRN) development, cybersecurity and safety signal, etc. The Program Director supports the board champion, steering committees, and work groups through project planning, timelines, deliverables, meeting facilitation, and action item follow up. As a Program Director, the individual assists with grant and contract submissions to support program funding. As a member of the MDIC team, he/she also contributes to the general advancement of MDIC goals, including membership advancement and support. This position reports to the MDIC VP, Clinical Science & Technology.

Objectives and Responsibilities 

  • Advance the field of clinical science and medical device regulatory science.
  • Promote collaboration and innovation within the medical device community with a special focus on the relationship between the FDA, CMS, and the private sector, and work to enhance the trust between all stakeholders.
  • Create tools, methods, and approaches that will assist stakeholders in developing new. products; assess the safety and effectiveness, quality and performance of these products.
  • Driven to achieve objectives and deliverables in the timeline required by the steering committee.
  • Provide education about the medical device regulatory process.
  • Provide education about the needs of the medical device community.
  • Support making the medical device regulatory process more expeditious, transparent, predictable, and effective.
  • Use established relationships with key stakeholders from industry, non-profits, and government including FDA and CMS to define and develop strategic areas of focus and opportunity.
  • Create a vision for defined opportunities and secure funding through membership support, grants, and contracts.
  • Complete and manage the detailed program and project plans so “clarity of purpose” can be established among team members and communicated broadly to membership and interested stakeholders.
  • Achieve critical mass of qualified membership to staff the steering committee and projects.
  • Establish and implement revenue, expense and staffing plans to appropriately grow the capability of the Program.
  • Establish the plan and appropriate relationships to deliver educational and administrative services.
  • Develop messages on project status in support of marketing and communication to advance utilization of tools, methods, and approaches.
  • Present and publish as needed to expand the reach of the MDIC work products to advance innovation within the medical technology industry (Medtech) and other stakeholder communities.
  • The employee will be responsible for communicating project plans and status to the VP, CEO, board champion, steering committee, working group members, and other stakeholders throughout the Medtech ecosystem.

Requirements

  • Bachelor of Science degree in a discipline related to clinical research (e.g., nursing, basic sciences, biostatistics, laboratory science, pharmacy, medical technology, medicine); advanced degree a plus.
  • 10+ years professional experience and 5+ years management experience in Medtech or Life Science industry in clinical research (i.e., clinical affairs, clinical development, clinical operations).
  • 5+ years as project manager for clinical studies on regulated products in the medical device industry; ideally, experience with all phases of research: early feasibility, feasibility, pivotal, and late-stage or post-market.
  • Recognized for acumen in the design and management of clinical studies to meet broad stakeholder needs and for clinical trial innovation (e.g., clinical trial efficiencies, evidence planning, real-world evidence, patient engagement, PROs, RWD/RWE).
  • Program management or equivalent experience with increasing levels of responsibility leading complex projects.
  • Understands the medical device product development lifecycle approach and process for taking a product through development to market.
  • Experience leading matrixed volunteer teams to achieve program results (i.e., team members from various disciplines or organizations without direct reporting relationships).
  • Influence management at junior and most senior levels of organizations.
  • Ability to coordinate and facilitate technical experts from various disciplines (within and outside of his/her own areas of expertise).
  • Excellent verbal and written communication skills.
  • Excellent interpersonal and influence management skills.
  • Experience identifying and managing relationships with communications and marketing vendors/consultants.

Other Skills/Abilities

  • Ability to represent MDIC at public forums such as conferences and symposia.
  • Comfortable participating as a panelist and present at public forums.
  • Demonstrated skills and ability to create a vision, generate broad support and secure resources and funding to support.
  • Excellent influence management skills.
  • Experience with Microsoft suite of products.
  • Self-directed.
  • Experience working with virtual teams.
  • Collaborative working style.
  • Entrepreneurial

Reporting Relationships

  • The employee will report to the VP, Clinical Science and Technology but have daily interactions with Program Directors in support of the various projects of the team.

NOTE: This scope of services is not intended to be all-inclusive. Individual may be asked to perform other related duties as required to meet the ongoing needs of the organization.

To apply:

Please send resume and cover letter to careers@mdic.org.  Include the position title in the subject line of the email.  Resumes will be reviewed on a rolling basis until the position is filled. No phone calls, please.  Only qualified candidates will be contacted by MDIC.

Project Manager, NESTcc

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Position Overview:

The Project Manager will be responsible for the day-to-day coordination of stakeholders, consultants, and staff working on the development and implementation of NESTcc’s organization goals under the overall direction of the Executive Director. The Project Manager will report to the Deputy Director and provide overall project support for NESTcc activities to advance the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE) and innovative research.

While working collaboratively with the NESTcc team on overall program objectives, this Project Manager position will focus on supporting the establishment, implementation, and management of the NESTcc Data Network. The NESTcc Data Network launched in Spring 2018 with an initial set of Network Collaborators. The establishment of the NESTcc Data Network is one of the key strategies for NESTcc as it establishes itself as the leading organization within the health technology and medical device ecosystem for conducting efficient and timely high-quality RWE studies throughout the total product life cycle (TPLC).

As a member of the MDIC team, the individual contributes to the general advancement of the MDIC mission and goals to advance medical device regulatory science through the work to establish NESTcc.

Objectives and Responsibilities:

  • Provides overall programmatic support to the Executive Director and Deputy Director to meet NESTcc objectives
  • Manages the submission process and review of application submissions to NESTcc for open-opportunities including for demonstration projects, test-cases, and Requests for Proposals (RFPs)
  • Supports that management of the awarded NESTcc projects utilizing the NESTcc Data Network, including the test-cases
  • Collaborate with project Principal Investigator(s) and site or project personnel on short and long-term project milestones and deliverables such as: memorandum of understanding (MOUs), conflict of interest (COIs), project timelines, communications activities, stakeholder convenings, and reporting requirements
  • Creates and maintains comprehensive project documentation for the NESTcc workflows
  • Plans and organizes data synthesis and analysis activities, including collecting and managing information about potential and existing NESTcc Network Collaborators, and engaging in outreach to potential and existing Network Collaborators
  • Coordinates, executes, and facilitates meetings with external partners and stakeholders, including acting as a liaison with funding agencies
  • Supports the advancement of the NESTcc communications strategy through communications collateral, social media, website development, and the development of conference sessions
  • Represents NESTcc and MDIC conferences and other events and meetings
  • Contributes to the overall development of the company, taking on responsibility or additional duties that may fall outside the general duties listed above.

Requirements:

  • Masters of Science/Arts candidate preferred
  • Bachelor of Science/Arts degree in the health-related sector required
  • 2-5 years of professional experience in healthcare, MedTech, Life Science industry, and/or clinical research as a project manager (private or non-profit sector)
  • Use and maintain strict confidentially, discretion, and judgment in dealing with confidential, sensitive and controversial issues in all aspects of work
  • Excellent verbal and written communication skills with the ability to write succinctly and quickly and comfort to interact both personally and professionally with staff and board members, stakeholders, and external executives
  • Manage multiple, ongoing projects in a fast-paced environment
  • Highly organized, detail-oriented and takes initiative
  • Exercise good judgment, and quickly identify and resolve problems
  • Ability to be flexible and work collaboratively as a team within a dynamic, start-up work environment that includes virtual teams

Other Skills/Abilities:

  • Knowledge of various Real-World Data (RWD) sources (electronic health data (EHR), Registries, patient-generated health data, Public and Private Claims, etc.) and study designs used for medical device products is advantageous
  • Knowledge of government regulatory agencies
  • Interest in the medical device industry and enterprise with a willingness to engage in continuous learning and professional and personal growth
  • Interest in developing a distributed data network
  • Natural ability to build relationships, lead and educate with excellent interpersonal and influence management skills
  • Strong skills in project management, PMP certification a plus
  • Excellent computer skills and experience with Microsoft suite products
  • Experience with a variety of web-based tools including SalesForce, RingCentral, Box.com, WordPress, Adobe Design, Zoom and ability to adapt to new collaborative technologies as they become available
  • Experience working with virtual teams is a plus
  • Some travel required
  • Self-directed, team-player with sense of humor

Reporting Relationships:

  • The employee will report to the NESTcc Deputy Director.
  • This employee will work closely with the full NESTcc team, including other Project Managers.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

MDIC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, MDIC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

To apply:

Please send resume and cover letter to careers@mdic.org.  Include the position title in the subject line of the email.  Resumes will be reviewed on a rolling basis until the position is filled. No phone calls, please.  Only qualified candidates will be contacted by MDIC.

Subaward Manager, NESTcc

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Position Overview

The Subaward Manager will be responsible for supporting full lifecycle of all NESTcc subawards, including enduring subawardee and contractor compliance with all award and MDIC policies. This position is for a self-motivated individual who is a highly organized, with excellent judgment for managing competing priorities effectively. The Subaward Manager, NESTcc will report to the Deputy Director, NESTcc and work closely with the MDIC General Counsel.

As a member of the MDIC team, the individual contributes to the general advancement of the MDIC mission and goals through the work to establish NESTcc. The mission of NESTcc is to accelerate the development and translation of new and safe health technologies, leveraging real-world evidence, and innovative research.

Objectives and Responsibilities   

  • Serve as the primary point of contact for NESTcc grants, contracts, procurement and subgrant management; proposal and award review; donor compliance; financial reporting; and agreements and funding mechanisms for subgrantees/subcontractors.
  • Responsible for the full lifecycle of all subawards for NESTcc, including ensuring subawardee and contractor compliance with all award and MDIC policies.
  • Ensure award funds are used properly, in compliance with all applicable federal and MDIC policies including OMB uniform guidance, FDA grant guidelines, and MDIC finance and administrative policies.
  • Track spending and review subrecipient burn rates against subagreement terms and contractual obligations.
  • Work with the team to develop required reporting lowest burden forms for the subawardees, including appropriate financial status reports.
  • Track project budgets, grant documents, contracts, and expenses to ensure alignment.
  • Support quarterly and annual financial grant reporting.
  • Manaing, compiling and providing routine reporting obligations to various stakeholders.
  • Support the development of Requests for Proposals (RFPs) and solicitations in alignment with funding requirements, MDIC policies and legal review.
  • Ensure all contracts and grant files are updated, accurate and accessible to program staff electronically.
  • Maintain applicable systems and databases.
  • Work in collaboration with MDIC operations to develop the necessary infrastructure to support subaward management.

Requirements

  • Bachelor’s degree is required, advanced degree preferred
  • At least 5 years of relevant experience working in grants management, subaward management, grant compliance, or a related field
  • Experience working with virtual teams is a plus
  • Some minimum local travel might be required
  • Experience with Federal grants or cooperative agreements
  • Ability to convey necessary information accurately, listen effectively, and ask questions when clarification is needed.
  • Can effectively cope with change and work independently.

Other Skills/Abilities

  • Maintain a positive, collaborative, professional work environment through effective communication of information.
  • Strong knowledge of administrative procedures, federal grant requirements, and contract development.
  • Forward thinking with the ability to anticipate the implications and consequences of situations and take appropriate action to be prepared for possible contingencies.
  • Ability to interact with employees, visitors, shareholders and others with ease and grace, adopting an “open-door” policy for all with strong multitasking abilities.
  • Experience supporting the development of processes and materials to support broad business initiatives.
  • Use and maintain strict confidentially, discretion, and judgment in dealing with confidential, sensitive and controversial issues in all aspects of work.
  • Confidence, flexibility, emotional intelligence.
  • Ability to remain calm under pressure.

Reporting Relationships

  • The employee will report directly to the Deputy Director, NESTcc and work closely with the NESTcc Executive Director and Project Managers to support overall goals and objectives. This employee will work closely with MDIC General Counsel and MDIC Director of Operations.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

To apply:

Please send resume and cover letter to careers@mdic.org.  Include the position title in the subject line of the email.  Resumes will be reviewed on a rolling basis until the position is filled. No phone calls, please.  Only qualified candidates will be contacted by MDIC.

General Counsel

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 Position Overview

The General Counsel is responsible for leading tactical legal initiatives and provides senior management with effective advice on operations and strategy implementation. He/she manages the legal function of the organization, serves as the liaison to the Board of Directors, addresses MDIC’s legal requirements and primarily ensures compliance in the following areas: corporate governance, federal compliance, federal funding reporting requirements, and Board of Directors meetings.

He/she provides support to the MDIC President & CEO with Board-related activities, including correspondence; material development, production, and distribution; and maintaining corporate records. The General Counsel must be able to maintain a high level of confidentiality when dealing with CEO , governance, and Board information.

In addition, this person works closely with MDIC senior leadership and outside legal counsel and contractors to support contract and compliance of all MDIC initiatives with a heightened focus on NESTcc contracts and operations. The General Counsel is directly involved in complex business interactions and negotiating critical contracts.

As a member of the MDIC team, the individual contributes to the general advancement of the MDIC mission and goals.  This position is self-directed.

Objectives and Responsibilities

  • Serves as key lawyer/legal advisor on all major business transactions and assumes ultimate responsibility for ensuring that the company conducts its business in compliance with applicable laws and regulations
  • Participates in the definition and development of corporate policies, procedures and programs and provides continuing counsel and guidance on legal matters and on legal implications of all matters
  • Develops subaward monitoring mechanisms in alignment with federal funding guidelines
  • Advises on legal aspects of the company’s financing, including assessing and advising on current and future business structures and legal entities
  • Oversees the selection, retention, management and evaluation of all outside counsel
  • Conducts legal research and analysis and draft legal documents, e.g. leases, licenses, memoranda of understanding, conflict of interest statements, contracts, and non-disclosure agreements with public and non-public partners
  • Establishes, implements and maintains “Best Practices” for the governance and effective operation of the Board of Directors and committees under the direction of the President and CEO
  • Attends Board meetings and draft minutes for the Secretary and President and CEO review
  • Maintains accurate records of Board appointments and committee assignments and assist with development and implementation of governance strategy
  • Supports the organization and maintenance of shared files pertaining to legal and Board matters
  • Provides regular updates on progress to the MDIC President & CEO
  • Supports MDIC’s mission of advancing the field of medical device regulatory experience

Requirements

  • Bachelor’s of Science/Arts degree from accredited college or university JD from an accredited college or university; concentration in Intellectual Property and Technology law , and/or Government Compliance preferred
  • Admitted to the bar
  • 10 or more years’ experience in positions of increasing responsibility in the active practice as counsel supporting C-level executives including Board reporting relationships
  • Complete knowledge of Federal laws and regulations, particularly as they relate to non-profit operations and federal grant compliance
  • Broad, overview experience in intellectual property law, including patent law, licensing of IP rights and IP due diligence
  • Verified ability to conduct and document legal research
  • Develop contracts, proposals, RFP’s, NDA’s, COI’s, project plans, and other written materials
  • Proved ability to accurately define and document legal problems and recommend correct solutions
  • Demonstrated ability to recommend, develop and implement legal “best practices” for procurement, regulatory compliance, and organizational policies
  • Ability to maintain strict confidentiality, discretion, and judgement when dealing with confidential and sensitive issues in all aspects of work
  • Capability to coordinate multiple priorities and complete tasks in a timely manner
  • Excellent computer skills, including Microsoft Office
  • Impeccable attention to detail
  • Outstanding verbal and written communication skills with the ability to be both personal and professional with staff and Board members
  • Excellent interpersonal and influence management skills
  • Exceptional problem-resolution and negotiation skills
  • Experience identifying and managing relationships with professional services vendors/consultants
  • Ability to follow-up and follow through on actions as necessary

Other Skills/Abilities

  • Professional experience in MedTech or Life Science industry preferred, but not required
  • Experience with Microsoft suite of products; SalesForce.com; box.com; Adobe E-Sign; WordPress; AdobeConnect; QuickBooks; Eventbrite and WebEx
  • Self-directed, self-motivated and a quick learner

Reporting Relationships

  • The employee will report directly to the MDIC President & CEO
  • Work closely with the Board of Directors, NESTcc Executive Director and Deputy Director, and the MDIC Director of Operations.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

To apply:

Please send resume and cover letter to careers@mdic.org.  Include the position title in the subject line of the email.  Resumes will be reviewed on a rolling basis until the position is filled. No phone calls please.  Only qualified candidates will be contacted by MDIC.

Data Network Director, NESTcc

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Position Overview:

The Director of the NESTcc Data Network will be responsible for the overall successful launch and growth of the NESTcc Data Network and its ability to progressively support a wider, and more exhaustive, range of research studies for medical devices, imaging, and diagnostic technologies.

The NESTcc Data Network director will continue to build, develop and maintain the NESTcc Data Network relationships with key organizations interested in participating in a device focused data network. Organizations may include health system providers, public and private payers, society and patient registries and other organizations with access to real world data supporting the mission of NESTcc. The person will continue to develop the data strategy in accordance with the NESTcc Strategic and Operational Plan for 2018-2022.

The NESTcc Data Network is anticipated to launch in Spring 2018 with an initial set of collaborators. The establishment of the NESTcc Data Network is one of the key strategies for NESTcc as it establishes itself as the leading organization within the health technology and medical device ecosystem for conducting efficient and timely high-quality RWE studies throughout the total product life cycle (TPLC).

As a member of the MDIC team, the individual contributes to the general advancement of the MDIC mission and goals through the work to establish NESTcc. The mission of NESTcc is to accelerate the development and translation of new and safe health technologies, leveraging real-world evidence, and innovative research. This position will have exposure to national leaders in the patient, medical device industry, academic and regulatory institutions and organizations.

Objectives and Responsibilities:

  • Lead the management of existing relationships with Network collaborators and develop new relationships to expand the scale of the Network.
  • Lead the development and execution of agreements between participating organizations and MDIC.
  • Work collaborative with the relevant NESTcc subcommittees to achieve subcommittee objectives in alignment with NESTcc strategy. This includes collaborating with the NESTcc Data Quality Subcommittee to ensure NESTcc Data Quality standards are being developed for use and developing processes for implementation of the standards to ensure Network Collaborators are meetings the NESTcc Data Quality Standards. This will also include working with the Methods Subcommittee to ensure high quality methodological standards are being met in studies associated with NESTcc.
  • Lead activities related to the Demonstration Projects, to catalogue and disseminate lessons learned, challenges, and solutions with respect to use of real-world data to support device studies.
  • Lead activities related to testing the NESTcc Data network, such as the initial test-cases being implemented with the Network Collaborators.
  • Lead the development of approaches and resources to streamline the administrative burden associated with contracting, IRB, Data-Sharing agreements, and publication policies for the parties working with the NESTcc.
  • As appropriate, lead reporting to the NESTcc Governing Committee and the MDIC Board.
  • Work collaboratively with the NESTcc team to meet aggressive timelines to achieve the objectives in the NESTcc Strategic and Operational Plan.
  • Manage staff as needed.

Requirements:

  • Advanced degree required (PhD, MD, MBA, or MS) in related area such as informatics, clinical research, or epidemiology
  • 8-15 years of related professional experience in health care, MedTech, or Life Science industry
  • Demonstrated leadership roles managing complex multi-stakeholder interactions
  • Proven ability to think strategically and implement complex solutions within an aggressive timeframe
  • Highly organized, detail-oriented and takes initiative
  • Outstanding presentation and writing skills
  • Proven ability to lead multiple, ongoing projects in a fast-paced environment
  • Exercise good judgment, and quickly identify and resolve problems
  • Ability to be flexible and work collaboratively as a team within a dynamic, start-up work environment to include virtual teams

Other Skills/Abilities:

  • Experience working with virtual teams is a plus
  • Some travel required
  • Self-directed, team-player with sense of humor

Reporting Relationships:

The employee will report to the NESTcc Executive Director.

To apply:

Please send resume and cover letter to careers@mdic.org.  Include the position title in the subject line of the email.  Resumes will be reviewed on a rolling basis until the position is filled. No phone calls please.  Only qualified candidates will be contacted by MDIC.

 

 

MDIC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, MDIC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

MDIC is an Equal Opportunity Employer.