Cochlear
Cochlear implants • Bone conduction solutions • Bionic Ear • Hearing Implants • Medical Devices
Director, Clinical Portfolio Strategy - Acoustics
November 6
Cochlear
Cochlear implants • Bone conduction solutions • Bionic Ear • Hearing Implants • Medical Devices
Description
• Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. • As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. • Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. • Cochlear is thrilled to announce a newly created Director of Clinical Portfolio Strategy role in our Gotenberg office—focusing on the Acoustics Portfolio, this role is specifically tasked with oversight of Acoustics products, ensuring all evidence needs relating to claims are addressed and managing the Gothenburg-based Clinical Audiologists to provide appropriate support and subject matter expertise to product design and validation. • In this pivotal role, you will lead a talented team of Clinical Development Managers and Clinical Research Audiologists. • Reporting to the Director of Clinical Design and Strategies, you will shape our clinical evidence strategies and ensure that our product portfolios meet the highest standards of innovation and efficacy. • Responsibilities include: Lead a High-Performing Team: Inspire and manage a talented team to develop and implement innovative clinical evidence strategies, study designs, and documentation for Cochlear's diverse product portfolios. • Drive Clinical Expertise: Leverage your clinical and scientific knowledge to identify unmet needs, shaping commercial solutions and strategic initiatives that make a real impact. • Collaborate for Success: Partner closely with commercial and R&D teams to ensure our evidence strategies align with business objectives and regulatory standards, optimising product design and market access. • Innovate with Emerging Technologies: Play a crucial role in integrating cutting-edge technologies that enhance candidate access to hearing care and elevate patient experiences. • Steer Clinical Evidence Strategy: Take charge of the short- to mid-term Clinical Evidence Strategy and Plan (CESP) for the Product and Services Plan (PSP), driving excellence across our portfolio. • Foster a Culture of Collaboration: Build and nurture strong partnerships across the organisation, promoting cross-functional teamwork to achieve common goals. • Develop Comprehensive Strategies: Oversee the creation of a robust evidence strategy that aligns with business objectives, ensuring a clear pathway to success for the portfolio area. • Drive Portfolio Planning: Lead the strategic planning and execution of the overall portfolio, ensuring seamless integration of all clinical initiatives. • Communicate with Clarity: Articulate clinical plans and strategies effectively to stakeholders, fostering alignment and understanding throughout the organisation.
Requirements
• Educational Background: You hold a Bachelor’s degree or higher in a scientific or healthcare discipline. • A PhD or tertiary qualification in Audiology, or experience in a hearing care setting or industry, is highly desirable. • Clinical Expertise: You bring approximately 10 years of experience in clinical research within the medical device sector or a relevant field. • Your background includes developing clinical strategies, study design, and reporting. • Leadership Experience: You have demonstrated ability in managing people, leading globally dispersed clinical research teams in pharmaceuticals or medical devices. • Your experience in a commercial environment enhances your ability to connect clinical strategies with business objectives. • Regulatory Knowledge: You possess a thorough understanding of the international device development process, including strong familiarity with Medical Device and Clinical regulations such as ISO 13485, ISO 14155, FDA 21 CFR, and MDR. • You have experience interacting with regulatory bodies like the FDA, TUV Sud, or TGA, leading to successful product approvals. • Communication Skills: You are a clear and effective communicator, with well-developed report and technical writing skills. • You are comfortable presenting complex information to various stakeholders.
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