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Chief Medical Officer

3 months ago

City of Merribek, Australia Nutromics Full time

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We're on a mission to revolutionize healthcare and we want you on board. Our vision is for a world with zero preventable deaths due to a lack of personalized and timely diagnostic insights.
Nutromics is developing a wearable diagnostic platform – the world's first "lab-on-a-patch." We're looking for people who are passionate about saving lives with groundbreaking, DNA-based, diagnostic technology.
We are growing quickly, expanding globally however, our passion for creating a better world will always be at the heart of it. Help us save millions of lives and change the face of healthcare.

The Role

In this role, you will develop and drive the Medical, Clinical Affairs and Regulatory Strategy. You will be supporting the organisation on clinical trials and KOL engagement during the life cycle of Product Research, Product Development through to commercialisation and supporting post launch clinical uptake. An important aspect of the role is advising and educating internal and external stakeholders on all aspects of the clinical and medical affairs strategy in alignment to product development. In addition, your role is to establish and manage our clinical advisory board. You will be responsible for the establishment of the clinical and medical team and subsequent processes and procedures.

Responsibilities

  • Lead the Medical / Clinical Affairs and Regulatory Department.
  • Develop a vision and strategy for the Medical Clinical and Regulatory department and ensure its alignment with the company vision and objectives.
  • Oversee the design and execution of clinical studies.
  • Oversee activities to secure regulatory approval and facilitate the successful launch of new products, ensuring comprehensive strategy and execution from clinical evidence gathering to market introduction.
  • Evaluate and advise on clinical viability of potential products to align with market demands and unmet clinical needs.
  • Lead reimbursement strategies and health economic outcome research to demonstrate product value, optimize market access, and ensure financial accessibility for patients.
  • Build and maintain relationships with key stakeholders such as regulatory agencies, key opinion leaders, physicians, patient advocacy groups, and potential collaborators, to facilitate collaboration, understanding, and support for Nutromics' initiatives and goals.
  • Build and oversee the clinical advisory board.
  • Act as a spokesperson and industry advocate, representing Nutromics in medical/scientific forums, conferences, and industry associations, and sharing knowledge to enhance the company's profile.
  • Required to regularly interact with venture capital and private equity firms globally to communicate the medical/ clinical strategy to achieve company's vision including clear articulation of clinical and patient needs.
  • Enhance the capabilities of the Medical Affairs function by developing and implementing processes and procedures that ensure compliance, effectiveness, and efficiency in supporting the company's strategic objectives.
  • Presenting the company's technology and clinical evidence at medical conferences.
  • Leading engagement with regulatory bodies to validate alignment between clinical strategy and regulatory requirements.
  • Ensure ethical standards and regulatory compliance, staying up to date with changing regulations in different global regions.
  • Establish strategic partnerships with healthcare providers, regulatory agencies, and industry partners to support the development, adoption, and commercial success of Nutromics' device.

Qualifications

Must have:

  • Board-certified MD or equivalent.
  • Demonstrated experience managing the complete life cycle of one or more diagnostic (IVD, point of care, or wearables) and/or medical device products.
  • Demonstrated experience successfully taking a medical device through a FDA regulatory pathway.
  • Demonstrated experience in clinical trial design and management.
  • Broad and strong relationships with key stakeholders in hospitals in Australia and the US.

Preferred:

  • Proven experience in startup/scale up.
  • Ability to effectively flex between a high-level vision and day to day operational requirements.
  • Specialization in Internal Medicine.
  • Experience working with hospital systems domestically and internationally.
  • Experience taking a product through 510k de novo and PMA regulatory pathways.
  • Visionary – strategically guide the discovery of unmet clinical needs to enable company's mission to revolutionize the diagnostics industry.
  • Ability to be effective in a high growth organization.
  • Ability to apply significant judgement on critical situations and decisions.
  • Ability to establish hypotheses or approaches not previously tested.
  • Ability to define, explain and own strategic planning.
  • Ability to make swift, high-quality decisions that support the execution of the overall strategy.
  • Ability to work in a lean start up environment with limited budgetary support.
  • Advanced skills in navigating a complex business landscapes.

Independence & Scope:

  • Defines the strategic direction and resource allocation for key organizational areas.
  • Responsible for crafting strategies and ensuring their successful implementation.
  • Ability to perform in a start/scale-up environment with lean teams and limited budgets.
  • Inspire change on a broad number of issues at large scale with long term impact and implications.
  • Define and modify practices within policy or regulatory guidelines and in line with company.
  • Fully accountable for work provided.
  • Excellent collaborator that mentors and educates the broader teams on clinical, medical, and regulatory aspects.
  • Ensure transparency regarding tactical and strategic matters to all key stakeholders.
  • Efficient and effective collaborator that seeks alignment on strategic and tactical needs.
  • Proficient in negotiating and influencing a varied number of stakeholders.
  • Ability to convince large and diverse workforce with multiple teams and competing demands in a collaborative approach.
  • Expertise in executive-level communication and stakeholder management.
  • Proficient in fostering collaboration across various business units.
Your application will include the following questions:

Which of the following statements best describes your right to work in Australia?

Are you available to travel for this role when required?

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