Senior Consultant, Clinical (AUS)

The Role

Requirements

Role Requirements

• Provide
  strategic, technical and regulatory advice/services to clients with a
  special interest in Clinical development of human medicinal products.
  
• Establish
  and maintain a high level of technical knowledge in product development
  and international regulatory affairs.
  
• Provide
  innovative drug development plans, data gap analyses and international
  regulatory strategies from a Clinical perspective for complex products
  within the changing regulatory environment.
  
• Contribute
  to technical authorship and review of development regulatory documents
  including Regulatory Strategy Plans, Drug Development Plans, Clinical
  Trial Applications, Pre -INDs, INDs, Scientific Advice and Meeting Briefing
  Documents, Paediatric plans/applications, Investigator Brochures, IMPDs,
  Marketing Authorisation Applications, New Drug Applications, Biologic
  License Applications, DMFs according to area of expertise.
  
• Lead
  multi -jurisdiction programs of work and deliver consulting services within
  your respective area of expertise.
  
• Represent
  clients in regulatory agency interactions and provide regulatory solutions
  to agency objections.
  
• Ensure
  delivery of project goals within agreed timelines, maintaining oversight
  of project budgets.
  
• Lead
  meetings with internal and external stakeholders on matters related to any
  current and/or future projects, contracts, or new business opportunities.
  
• Support
  Scendea's Business Development in sales/marketing introductions and
  generate additional business from current clients.
  
• Line
  manage, train, and mentor members of the Scendea Operational team,
  including providing technical leadership.
  

Skills and Experience

• A
  high scientific calibre with a relevant science focused BSc (or
  equivalent), and a higher degree in a biomedical field or equivalent
  (e.g., a life/physical science focused MSc or preferably a PhD).
  
• A
  minimum of five years of drug development experience.
  
• A
  minimum of five years of regulatory experience, working with either TGA, FDA,
  EMA, and/or MHRA submissions, including meetings/negotiation. Regulatory
  experience may include time within a National Competent Authority.
  
• Demonstrated
  clinical development experience across a range of therapeutic
  indications/disease areas.
  
• Direct
  experience preferred in providing strategic regulatory planning from
  early -stage development up to marketing authorisation, and a proven
  ability to define and deliver creative scientifically driven solutions to
  technical development and regulatory issues.
  
• Proven
  ability and willingness to lead a team and deliver education and training
  in chosen field, both internally, and at scientific conference
  presentations.
  
• Exemplary
  organisational and time management skills with a high level of attention
  to detail, and the proven ability to work both proactively and
  autonomously.
  
• High
  level of verbal communication and presentation skills in English, computer
  literacy, and competency in MS Office programs.
  
• Willingness
  to work flexible hours and travel for short periods, sometimes at short
  notice, within the country of employment, or internationally.
  

The Company

Scendea is an international product development, regulatory,
and compliance consulting group delivering market -leading scientific expertise
& regulatory solutions, to advance healthcare innovation worldwide. We are
passionate about delivering strategic and operational support to clients, with
a strong commitment to problem -solving and redefining customer service. Our
goal is to streamline the product development process, reduce time -to -market,
and minimise overall development costs. 

With a current team of over 50 staff based in the US, UK,
Netherlands, and Australia, Scendea is undergoing a period of significant
growth, with the addition of new service lines to facilitate the delivery of
expert and strategic global regulatory and compliance consulting services to
our rapidly growing client base. We are equally committed to making a positive
impact on society by managing our environmental impacts and contributing to a
low -carbon economy. Our inclusive work culture values transparency, ethical
collaboration with clients, and employee involvement in key decision -making
processes, ensuring that our team is respected, supported, and engaged.

Benefits

Benefits Package

• A
  competitive salary.
  
• Generous
  bonus program, which rewards success.
  
• 26
  days’ annual leave entitlement plus public holidays and discretionary
  additional days leave for birthday and work anniversaries. 
  
• Employer
  pension contribution/ compensation in line with country specific
  legislation.
  
• Provision
  of / compensation of Private Healthcare insurance.  
  
• Access
  to Employee Assistance Programme.
  
• Employee
  Ownership Trust Scheme.
  
• A
  challenging and stimulating position for a dynamic and competent
  scientist, looking to contribute to a growing business and a rapidly
  expanding team.
  
• Coaching,
  mentoring and support of your continuous learning, and professional
  development within a highly recognised international team.
  

As a Scendea Employee

Part of what makes Scendea successful is the highly
motivated people who work for us and their enthusiasm for what we do and stand
for. We recruit individuals whose passion, drive, integrity and
customer orientation shines through.  You are a motivated individual who
can instil trust and confidence in our customer relationships whilst having a
natural aptitude for getting the best out of people internally. You will
inspire others through your commitment, motivation, expertise,
professional manner and always placing the customer at the centre of everything
you do.  

Eligibility & Conditions

Applicants must
reside and be eligible to work in Australia without the requirement for
sponsorship now or in the future.