Senior Product Development Consultant

• Pharmaceuticals
• Biotechnology
• Non-clinical

The Company
Our client is integral to all stages of the product development cycle and subsequent success for international & Australasian companies across the healthcare landscape. Their clients include leading local & international pharmaceutical, biotechnology & medical device organisations, including startups and university and Institute spin outs.
They offer high quality, integrated fit-for-purpose solutions across the value chain to bring innovative therapies to market. Definitely no 'siloing' in this opportunity, your exposure to projects across multiple companies and markets will ensure you become an expert in your field & be integral in ensuring our client maintains their position as a preferred provider of choice.

The Opportunity
As our clients new Product Development Consultant/ you will play a pivotal role in driving multiple pharmaceutical product development projects from concept to clinical execution. You will support their client's non- clinical, analytical and manufacturing activities and inform strategy to help bring safe and effective new drugs and therapeutics to the clinic and to market. You may have some, or all of the expertise detailed below:

• Comprehensive understanding of the regulatory, scientific, medical and commercial aspects of drug development and approval in key local and international markets, including the US and Europe.
• Support activities requiring a sound knowledge of the type and quality of non-clinical evidence necessary to support clinical trials and registration.
• Support clients navigate complex analytical, formulation, scale-up and technology transfer challenges and validation study design to achieve manufacturing readiness
• Contribute to strategic planning and resource allocation across drug development programs.
• Assist in the preparation of technically complex regulatory dossiers e.g. pre-IND briefing documents and IND submissions
• Support Business Development, attending client meetings, scoping projects and developing proposals. Participate in internal and external client project meetings.
• Maintain knowledge and oversight of the relevant national and international regulatory standards: including FDA, TGA, EMA
• Working closely with other members of the team, to deliver a superior client experience, optimise project outcomes, and contribute to the culture and capabilities of their teams.

The Requirements

• Tertiary qualification in Pharmaceuticals, Biotechnology, Science, Chemistry, Pharmacy or another relevant field.
• Higher Degree qualifications in a relevant scientific field and/or MBA will be highly regarded.
• High level written and oral communication skills and excellence in medical/regulatory writing.
• Highly organised with the ability to multi-task and work independently and collaboratively.
• External stakeholder relationship management skills.
• Excellent skills in project management and coordination of CDMOs and other vendors.
• Experience managing CMC and Non-clinical activities as part of a multi-year development programs.
• Knowledge of at least two therapeutic areas and modalities

The Offer
This is a new and rare opportunity to join an innovative team of experts and make a significant contribution to the development of exciting new drugs. The level and title of this appoint may be higher for an experienced candidate who is an excellent fit. The role could be Product Development Consultant or Senior Consultant. The position is available remotely and can be located in any state.

Please email questions and expressions of interest to Mark Thomas or Marilyn Jones at [email protected] or call 1300 063 932. To apply, please visit www.mexec.com and click Apply Now to submit a copy of your current CV and cover letter.