Primary Role

Under the direction of the Senior Director Medical Devices and Combination Products, the Clinical Program Lead, Clinical Development Medical Device and Combination Products will be responsible to serve as the device clinical representative on assigned project teams, sub teams and corporate initiatives.

The candidate will have demonstrated ability to manage multiple programs, therapeutic areas and/or work streams with a high degree of complexity; advanced understanding of the device development, execution of clinical programs and clinical studies to support novel drug delivery devices and combination products.

In addition will have in-depth knowledge of global regulatory/industry rules and guidance’s (e.g. ICH, GCP, and labeling) to drive the strategic approach to medical device approval and clinical trial supporting documents development process. The Clinical Program Lead, Medical Devices is responsible for working closely cross-functionally with other global teams including Device Development, Quality Assurance, Clinical Operations, Global Regulatory, Drug Safety, Commercial, and Legal.

Responsibilities

50% Oversight with an emphasis on strategic planning, implementation and execution program and work stream plans for therapeutic indications or company initiatives in keeping with corporate and department goals.

Participate in/or lead cross-functional teams in the development of clinical program deliverables including product labels, clinical trial training material, clinical and scientific summariesManage and present clinical safety data involving drug and device variablesEngage data management and biostatistics teams to collect and present clinical data summaries for cross functional reviewAssess decisions from other functions and the impact on the program or work stream planProvide update and direction to Sr. Management when conflicts, key developments and program scope/direction changes are identified.Effectively represent the interests and perspective of the Clinical Development Devices team

40% Assess skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources

Lead internal and external medical writing resources to develop clinical summaries, clinical study reports, clinical evaluations, and pediatric assessments for submission to regulatory bodiesLead or participate in the development and maintenance of policy and SOPs designed to ensure alignment with regulations, guidance, and internal company requirementsLead or participate in the development of instructions for use, product administration guides, and similar training material including procurement and clinical oversight of artwork and administration stepsAssures clinical study design and data generated meets regulatory authority requirementsLeads safety review input for medical devices and combination productsAlign with team members from other functional areas regarding planning, implementation, tracking, analysis and report of milestones

5% Participate in business development and process improvement activities as needed

Contributes to the clinical study design for medical devices and combination productsUnder the direction of the Senior Director, Clinical Development Medical Device and Combination Products participate in due diligence activities

5% Other activities as deemed by management

Participate in Research and Development, department and/or corporate wide task forces as appropriateProvide briefings and deliver technical presentations for top management

Education & Experience Requirements

Bachelor’s degree in life sciences. Advanced degree a plus however not required.Minimum 6 years of experience in pharmaceutical, device or biotechnology field.Minimum 2-4 years of experience in clinical research environment.Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authoritiesExperience with the Medical Device Regulation (MDR) and clinical evaluationKnowledge product development and design control in device and combination products

Skills & Knowledge

Understanding of device design and product development. Demonstrated ability to work on multiple programs and/or therapeutic areas associated with a high degree of complexity; known as effective resource for organization, execution, problem solving and influencing cross-functionally. Solid knowledge of device FDA, ICH, GCP, MDR guidelines.In depth knowledge and experience evaluating, and leading teams to evaluate, clinical literature, clinical summaries, clinical protocols, and materials that include clinical data and safety data in medical device and combination products.Ability to execute in and manage multiple programs simultaneously.Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences.  Ability to act as company spokesperson or scientific witness as needed.Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes

Complexity and Problem Solving

Strong interpersonal skills and motivates individuals and teams towards achieving results.Requires ability to critically assess processes, identify opportunities and implement improvements while collaborating with other functional experts.Requires high degree of problem solving ability; understanding of objectives and processes across multiple organizational functions.

Internal & External Contacts

Internal interactions with Drug Clinical Development, Device Development, Medical Affairs, Program Management, Regulatory Affairs, Commercial, Legal, Quality, Compliance, and Drug Safety.External interactions with medical writing consultants, contract research organizations, core laboratories, investigators & investigation sites, patient organizations, KOLs and other stakeholders as identified.

Other Requirements

Availability to travel up to 25% of time.