Head of Medical Affairs and Clinical Development
Vor 2 Tagen
Pharmaceuticals & Medical Devices (Healthcare & Medical)
Full time
Add expected salary to your profile for insights
Some opportunities happen only once in a lifetime - like a global role where you have the chance to make a difference in improving patient outcomes. Medical Developments International (MDI) is one of Australia’s leading specialised pharmaceutical companies with an industry-leading range of products in areas of pain and respiratory.
We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognise that nurturing the diverse perspectives and strengths of our people translates into patient care.
We are a global company headquartered in Melbourne and are looking to hire a Head of Medical Affairs and Clinical Development with proven experience in leading this critical function.
Who are you?
You will be an accomplished, strategic Medical Affairs and Clinical Development executive from thebiotechnology, medical devices, or pharmaceutical industry. Experience in pain and respiratory medicine is preferred but not essential. You have a deep understanding of the industry’s complex medical affairs, regulatory, market access requirements with an absolute commitment to competing globally on the highest ethical level.
- Lead the global Medical Affairs, Medical Information, Pharmacovigilance, and Clinical Development functions
- Reporting to the CEO as a member of the executive leadership team.
- Build your career in a transforming global healthcare organisation
- Your key remit will be to strategically develop & execute global strategies forMedical Affairs and clinical development, including: Lead and manage high-performance medical affairs, pharmacovigilance, clinical development team, and related support functions.
- Work closely with the CEO and senior management colleagues to develop the overall strategic direction to evaluate alternative strategies, identify competitive issues, capitalise on core strengths, and develop and implement operating plans.
- Develop a global strategy for medical affairs, including evidence generation and clinical trials and the scientific communication platform that is aligned with product strategy for MDI’s medical devices and medicines.
- Develop medical strategy, including publications strategy, customer interaction strategy, and the scientific communication platform, aligned with product strategy.
- Oversee pharmacovigilance activities for MDI’s products. Work closely with Qualified Persons Responsible for Pharmacovigilance (QPPVs) in the countries where products are registered.
- Maintain clinical, scientific and technical expertise through conferences, technical meetings and symposia, review of scientific journals and partnerships with product and technology experts.
- Responsible for reviewing promotional and educational material for accuracy, supporting consultant and advisory meetings, and coordinating grant applications for scientific merit.
- Identify and recommend physicians or KOLs as potential participants of advisory boards and speaker bureaus to discuss MDI products and other medical/scientific topics of mutual interest.
- Convey scientific and medical information to health care professionals to inform and educate them on the quality use of MDI products.
- Oversee the project plan and strategy for global clinical trials specifically in the US and Europe.
- Provide support to regulatory submissions and approvals, along with the Regulatory Affairs and other MDI senior leaders i.e. FDA, TGA.
- Manage and execute global contracts in collaboration with legal and commercial to ensure exceptional partnerships with the stakeholders.
Key Requirements/ Qualifications/Prior Experience
- Medical degree (MD), PhD, PharmD (or equivalent), preferably in pain management, respiratory drug development or medical devices.
- Minimum 8 years' experience in the pharmaceutical industry in Medical Affairs, with proven track record.
- Proven expertise in engaging KOLs and other key stakeholders (eg health care authorities, medical and scientific organisations).
- Experience in drug development, commercialisation of drugs and direct interaction with international regulatory agencies (European, FDA) is highly desirable.
- Experience in clinical development is an advantage.
- Strong leadership skills, with proven experience in leading teams.
- Ability to work in a fast-paced, complex and dynamic environment, as well as the proven track record of working effectively across multifunctional teams.
- Manage work across time zones with international partners or stakeholders.
- Outstanding organisational and problem-solving skills are essential for managing multiple projects simultaneously.
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