Director Clinical Portfolio Strategy, Acoustics
Cochlear Bone Anchored Solutions AB / Civilingenjörsjobb / Göteborg
2025-02-27
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hela Sverige Job Overview & Purpose: The Director Clinical Portfolio Strategy reports to the Director Clinical Design and Strategies and is responsible for leading a team of Clinical Development Managers and Clinical Research Audiologists. The team will deliver Clinical Evidence Strategies, study designs, and study documentation for Cochlear product portfolios. This role will also provide subject matter expertise to product design and execute in-house clinical investigations to support business needs. The Director will bring clinical and scientific expertise into the portfolio domain, driving clinical science and understanding unmet clinical needs to contribute to commercial solutions and strategy definition. Additionally, the Director will be a key contributor to roadmap forward planning for the integration of emerging technologies.
Key Responsibilities:
Drive Clinical Evidence Strategy and Plan:
* Lead a team to develop a comprehensive Clinical Evidence Strategy and Plan (CESP) for products and systems within the Portfolio area.
* Ensure processes and forums exist to communicate CESPs and planned evidence activities.
* Assimilate key inputs from Clinical and represent the function as the consistent point of contact for the Portfolio.
* Develop, maintain, and communicate scenario plans for the Portfolio.
* Close knowledge gaps through literature reviews, data collation, and analyses.
Maintain and Enhance Cross-Functional Collaboration:
* Promote a culture of cross-functional collaboration as input to clinical strategy and product design.
* Partner with GSM to contribute to desired claims and evidence needs to support key markets.
* Work in partnership with R&D to ensure Clinical representation and input at appropriately defined timepoints and milestones throughout the Product Innovation Process (PIP).
Lead Development of End-to-End Evidence Strategy:
* Lead the development of an aligned end-to-end strategy for the evolution of the Acoustics portfolio.
* Ensure efficient and effective transfer of evidence and knowledge from Advanced Innovation to the Portfolio.
* Drive the clinical science for the portfolio, identify gaps and ambiguity in knowledge and evidence.
Drive Planning and Delivery of Overall Portfolio Strategy:
* Plan at Portfolio level to ensure appropriate resource allocation.
* Oversee and develop study documentation to ensure compliance with GCP and business processes.
* Lead or support the team in discussions with internal stakeholders to develop study design concepts.
Effectively Communicate Clinical Plans:
* Communicate and advocate for the lifetime portfolio strategy across cross-functional project teams.
* Ensure that the clinical portfolio strategy and research priorities are well understood and aligned with the needs of the evidence to be gathered and the studies to be undertaken.
Integrate Clinical Audiology and Clinical Portfolio Functions:
* Ensure team members are allocated to projects in line with their expertise and business needs.
* Identify gaps and opportunities for the Clinical Audiology function to optimally support product design.
* Strengthen networks and communication mechanisms between CSI Clinical Audiology teams and regional audiology and ClinTech teams.
Team Role:
* Actively promote the quality management system and ensure that all staff are trained.
* Build capability of people managers and their teams to attract, develop, and retain top talent.
* Demonstrate WH&S leadership and ensure that people are suitably trained to perform jobs effectively and safely.
Minimum Key Incumbent Requirements:
* 10 years of experience in clinical research within the medical device sector or relevant field.
* Demonstrable exposure to commercial business needs and experience in balancing needs of internal stakeholders.
* An Enterprise mindset with the ability to see the "big picture".
* Resilient, resourceful, and solutions-oriented.
* Demonstrated ability in managing people and creating a positive working environment.
Desired Skills:
* Bachelor degree or higher in a scientific or healthcare discipline.
* Experience in development of clinical strategies and in study design and reporting.
* Thorough understanding of international aspects of device development process.
* Familiar and comfortable with FDA, TUV Sud or equivalent Notified Body, and TGA regulations.
* Clear and effective communicator with well-developed report and technical writing skills.
* Familiar with data management and interpretation methods.
* Comfortable with regular travel as deemed appropriate.
Certifications:
* PhD or tertiary qualification in Audiology.
* Experience in hearing care setting or industry.
* Leadership of a globally dispersed clinical research team in either pharmaceuticals or medical devices.
* Familiar and comfortable with clinical concepts and practices in the field of hearing.
Education:
* PhD or tertiary qualification in Audiology.
Languages:
* English - Fluent.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2025-08-26
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-620684".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Cochlear Bone Anchored Solutions AB (org.nr 556561-7114)
Arbetsplats Cochlear
Kontakt Martin Karlsson
makarlsson@cochlear.com Jobbnummer 9190668