Director, Country Head Clinical Operations

Melbourne, Australia | full time | Job ID: 9293

As Director Clinical Operations (Australia Country Lead) you provide leadership and strategic management of all clinical operations activities in Australia. In this role you interact with and influence senior level management, external vendors, collaborations partners and clinical study personnel for clinical trials.

Your main responsibilities are:

• Accountable for execution and delivery of sponsored human subject research across all therapy areas and development phases in Australia to quality, time, budget, and resources as defined in the trial protocol as well as in local. regulations, ICH GCP / IND guidelines, and BioNTech written standards.
• Responsible for providing clinical monitoring oversight for studies executed by our strategic partners in Australia.
• Actively engage with local partners and regulatory stakeholders to maintain and influence a positive operational environment for clinical trials in Australia.
• Driving business efficiencies, implementation of new processes and quality improvement, facilitates sharing of best practices, learnings, and expertise at a local, regional, or global level where appropriate.
• Ensuring the quality and integrity of clinical trials and actively identifies and manages any internal and external risks to the business.
• Promoting the profile and credibility of the department with internal groups as well as external groups (hospitals, GP networks, physicians, HCPs, industry initiative groups etc.)
• Ensuring strategic local input is provided at early stages of clinical development planning to optimize in-country trial feasibility.
• Building a strong collaboration with CRO teams to optimize delivery of clinical trials in Australia.
• Collaborate with the global and local team and support opportunities to build strategic relationships with trial sites in Australia.
• Contributing to the development and review of portfolio documents including: Trial Oversight Plans, Integrated Development Risk Management Plan Trial RACI matrix, Participant Recruitment and Retention Plans and SOPs.
• Supervision of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training.
• Point of escalation in case of challenges in project activities with other BioNTech departments or external vendors.
• Instruction, supervision and performance management of ADCT, CTMs, CTCs, CRAs and CTAs (line Management) possible.
• Resource planning of the team in alignment with the Senior Director Clinical Operations Portfolio Leader.
• Accountable for strong leadership, people management, talent retention and development of the local Clinical Operations team, providing direction and vision. Translates the organization vision, mission and strategy into coherent plans / requirements that can be understood and implemented by clinical research staff. This includes ensuring that all teams understand and operate according to the agreed business priorities, regulatory requirements, and internal processes to ensure excellence in the delivery of studies and projects
• Developing and implementing a resourcing strategy (internal staff and/or external resources) to ensure availability and competency of resources required to meet portfolio requirements
• Responsible for identifying local vendors to support local and global trial execution
• Contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors
• Overseeing local project/program timelines and deliverables and identification of future requirements for the successful execution of a program
• Cultivating strong relationships with sites, government agencies, patient advocacy groups and local vendors including but not limited to CROs
• Overseeing the training status of the local project team and reporting training requirements to the Senior Director Clinical Operations
• Responsible for team development, identification of high-performing team members and working on team development together with the Senior Director Clinical Operations
• Supporting the QA team during internal audits, vendor audits and/or hosting inspections in Australia
• Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)
  
  

What you have to offer:

• Minimum 12 years of experience in pharmaceutical/biotech or related industry with at least 8 years in Global Clinical Development leading cross-functional teams.
• Bachelor’s degree in life sciences or a university degree in a related field.
• Profound knowledge and experience working with relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects. Directly involved in addressing regulatory inspections or internal process audits. Involved in drafting/reviewing responses to health Authority and ethics committee questions.
• Operational excellence in delivering clinical trials.
• Successful track record in, developing innovative solutions to accelerate trial start up and participant recruitment.
• Proven ability to navigate a matrix environment and partner effectively with internal stakeholders, CROs, sites, HREC and the TGA.
• A strong background of successful interactions with HREC and TGA.
• High proficiency in clinical trials involving complex design features (e.g. multiple arms, adaptive designs, treatment combinations) .
• Excellent written and verbal skills required.
• Proficiency in using Microsoft software (Word, Excel, Power Point, MS Project).
• Must be a demonstrated self-starter and team player with strong interpersonal skills.
• Ability to motivate and lead a team.
• Attention to detail with the ability to recognize problems and offer practical mitigating solutions.
• Excellent organizational, analytical and critical thinking skills.
• Results-oriented mind-set, and ability to manage competing priorities to meet or exceed targets at a country level.
• Willingness to travel ~10%-20% of time.
  
  

Your Benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.