Cochlear is the global market leader in implant hearing solutions. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It's an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.
The opportunity:
The Clinical Portfolio Manager position reports to the head of the Advanced Audiology Clinical (AAC) department within Advanced Innovation and is a member of the AAC management team. This role is a blend of part-time team management, overseeing AAC staff in both Melbourne and Sydney offices, and managing a Clinical Studies Portfolio. Such a portfolio includes several clinical studies that support an Advanced Innovation research program, which are conducted globally across all Advanced Innovation sites. These clinical studies, primarily feasibility studies, provide vital early clinical evidence and user needs to meet the tollgate criteria for technology development.
Based in Melbourne the Clinical Portfolio Manager provides input into the strategy and the project planning. Additionally, the Clinical Portfolio Manager engages in structured interactions with corresponding roles in the Global Clinical organization as part of the technology transfer process.
Other responsibilities include:
- Forecast and embody the long-term evidence needs in line with the technology development program and overarching clinical strategy.
- Collaborate with technical stakeholders to align the clinical plan with technology outcomes, ensuring it fulfills the research program's requirements to mitigate technology risks prior to transfer.
- Lead the clinical science within the portfolio by identifying and addressing gaps and uncertainties in knowledge and evidence.
- Work with clinical innovators and technical leaders, review literature and competitor developments to guide and shape the technology roadmap.
- Predict the evidence requirements for the technology development program and generate clinical evidence to support clinical uptake and regulatory approvals.
- Track the performance and obstacles of new products in the market to complete the feedback loop, using these insights to guide future technology development.
- Participate in feature teams during product development, or ensure clinical insights are well-represented, to bolster and enlighten product design decisions.
- Demonstrate active involvement in the implementation and improvement of relevant quality procedures.
- Attract, develop, and retain the best team to deliver Cochlear's current and future business objectives, for example, by:
- Ensuring clarity of expectations and outcomes for individuals and team
- Providing regular feedback on performance and alignment with the HEAR behaviours
- Providing coaching for growth and success to build individual and team capability
What will see you succeed in the role:
- Deep expertise in audiology, and hearing implants in particular
- Evidence of study design/clinical research expertise in an associated field
- Demonstration of good knowledge of regulations (ISO13485, ISO14155, ISO9001, FDA 21CFR820)
- Clear and effective communicator with well-developed report & technical writing skills
- Cross-functional networking and facilitation skills
Desired Skills
- Experienced in People leadership
- Ability to critically appraise and assimilate complex information from multiple sources to inform study and technology design.
- Experience in medical device/pharmaceutical industry - 3-5 years minimum
- PhD training or equivalent through scientific experience
- Clinician experience in a hearing clinic
- M.Sc. in Audiology, ideally PhD level
Cochlear's mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry's best clinical, research and support networks. That's why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life's opportunities.
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How we recognise your contribution
We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment w