Medical Lead

2 months ago

Sydney, Australia Grand Pacific CRO Full time

About Us:
The Grand Pacific CRO team has over 25 years’ experience in conducting clinical trials in the Asia Pacific region, including Australia, New Zealand and South Africa. We have continued as a leader in the industry and have expanded services to include central laboratory, site management and image reading services. We pride ourselves on meeting customers where they are and providing exactly what they need to move their products forward.

Job summary

The Medical Lead for the designated therapeutic area will provide expert advice to both internal and external stakeholders. Apart from the knowledge of disease Staes ad treatment options, the incumbent will strategically design clinical trials on investigational products as well as play an active role in safety monitoring of ongoing trials. The Medical Lead will work closely with other functions in the organisation such as medical writing, clinical development and senior management team.

Measurement
- Successful design of clinical trial protocols for clients
- Establish a pool of study sites and KOLs for relevant therapeutic areas
- Effective handling and resolving clinical/medical related issues
- Successful provision of therapeutic area education and training

Responsibility
- Development of partnerships with sponsors, investigators, opinion leaders and healthcare professionals
- Providing strategic medical advice to both internal and external stakeholders
- Active participation in sponsored clinical trials including, and not limited to:
Strategic planning and study design

Country/site/investigator selection

Development of Protocol synopsis, Protocols, Investigator Brochures, Manual of Procedures, Patient Informed Consent Forms and other essential documents

Regulatory and Ethics Committee submissions
- Development, implementation and management of preclinical activities, inclusive of but not limited to:
Preclinical development expertise and advice

Scientific projects and research

Development of protocols and protocol synopsis

Medical Writing
- Providing medical support to other functions such as clinical development, data management, business development
- Active participation with medical educational programmes, advisory boards and therapeutic area training. Design and delivery of formal scientific training
- Writing of Grand Pacific CRO SOP's and Working Instructions
- Active participation in Grand Pacific CRO Team Meetings and sharing and implementing of new innovative ideas within the teams is required.

Delivery
- Actively participate in clinical trial development and execution
- Build partnerships with external healthcare professionals
- To communicate evidence based critical scientific
- provide therapeutic area education and training
- Overcome technical and development issues relating to company service

**Qualifications**:

- A medical doctor preferably with a PhD in relevant therapeutic areas

Technical knowledge & skills or other requirements
- The ability to understand, process, communicate and present scientific information to a high standard
- Possess excellent presentation skills
- External customer focus with strong networking capabilities and integration with KOLs
- Understanding of clinical development and Good Clinical Research Practice is preferable
- Excellent influencing, networking, presentation and communication skills and a proven track record of team cross-functional team working
- Ability to manage multiple projects and adapt priorities according to business and strategic needs
- The highest ethical standards, with a working knowledge of relevant clinical regulations and industry standards including Good Clinical Research Practice
- Excellent skills using Microsoft Office Suite, MS Powerpoint, MS Word and MS Excel

Work experience
- Pharmaceutical industry or Contract Research Organisation is beneficial but not required

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