Clinical Development Strategist

2 days ago

Sydney, New South Wales, Australia C01 Cochlear Limited (Australia) Full time

About Us

Cochlear Limited (Australia), a renowned global leader in implantable hearing solutions, empowers individuals with severe to profound hearing loss to experience life's opportunities.

We are driven by our mission to help people hear and be heard. Our dedication to innovation and excellence has made us the preferred choice for those seeking transformative hearing solutions.

The Role

We seek an experienced Clinical Development Manager to join our team in Macquarie, Australia. As a key member of our clinical development team, you will play a pivotal role in shaping our product strategies, ensuring regulatory compliance, and driving clinical impact throughout the product lifecycle.

Key Responsibilities:

  • Develop and contribute to clinical program strategies that support product approval and lifecycle management.
  • Collaborate with cross-functional teams to align portfolio strategies with business objectives, fostering a culture of transparency and open communication.
  • Design clinical investigations, oversee study documentation, and maintain clinical strategies, ensuring seamless execution and timely delivery.
  • Support training initiatives to ensure compliance and alignment across study sites, promoting a culture of continuous learning and growth.
  • Engage in data collation, analysis, and clinical alignment to bridge knowledge gaps, empowering informed decision-making.
  • Advocate for portfolio strategies and optimize collaboration across project teams, driving productivity and efficiency.

What Makes This Opportunity Unique?

This role offers a rare chance to work at the forefront of clinical research within the medical devices industry, focusing on cutting-edge hearing solutions. You will collaborate with global teams, driving strategies that help Cochlear deliver life-changing products with measurable impact worldwide.

About You

To succeed in this role, you will possess:

Essential:

  • A minimum of 3 years of relevant experience in the medical device/pharmaceutical industry, preferably in clinical project management or research roles.
  • Degree-level education in a health-related or science field.
  • Proven expertise in study design, regulations (ISO13485, ISO14155, MDR, FDA21CFR820), and strong report writing/technical communication skills.
  • Resilience, resourcefulness, and solution-oriented mindset.
  • Familiarity with data management and interpretation.

Ideal:

  • Experience in writing clinical protocols, investigation reports, and planning evidence strategies for regulatory submissions.
  • Commercial acumen and knowledge of hearing science practices.

Salary Range: AU$90,000 - AU$110,000 per annum, depending on experience and qualifications. We offer a competitive salary package, including benefits such as flexible working arrangements, professional development opportunities, and a dynamic work environment that values diversity and inclusivity.

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