At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for an Associate Project Director (APD) to join our A-team (hybrid*/remote). As an Associate Project Director at Allucent, you are responsible for overseeing and managing all aspects of clinical trials from start up through to final delivery for a range of therapeutic areas. This role plays a pivotal part in ensuring the successful execution of trials, from initial planning through to completion, with a focus on safety, regulatory compliance, and efficient project management.

In this role your key tasks will include:

• Strategic Planning: Develop and implement strategic plans for Central Nervous System (CNS) or Cell and Gene Therapy (CGT) trials, including defining project objectives, timelines, and resource allocation.
• Trial Management: Oversee the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Budget and Resource Management: Manage project budgets and allocate resources effectively. Monitor expenses, identify cost-saving opportunities, and report financial progress to stakeholders.
• Team Leadership: Lead and supervise a cross-functional team, including clinical research professionals, project managers, and support staff. Foster a collaborative and motivated work environment.
• Regulatory Compliance: Stay up-to-date with evolving regulatory guidelines and ensure that trials are conducted in compliance with relevant regulations (e.g., FDA, EMA).
• Risk Management: Identify potential risks and develop risk mitigation plans to ensure trial success and patient safety.
• Vendor Management: Select, contract, and manage external vendors and partners, such as Contract Research Organizations (CROs) and laboratories, to support trial activities.
• Data Management: Oversee data collection, analysis, and reporting activities, collaborating with data managers and biostatisticians to ensure data quality and integrity.
• Safety Monitoring: Implement safety monitoring protocols and procedures, ensuring timely reporting of adverse events and appropriate interventions.
• Communication: Maintain effective communication with internal teams, external stakeholders, investigators, and regulatory agencies. Provide regular updates on trial progress.
• Quality Assurance: Implement quality control processes and continuous improvement initiatives to enhance trial quality and efficiency.
• Documentation: Ensure accurate and comprehensive documentation of all trial-related activities, including study protocols, informed consent forms, and regulatory submissions.

To be successful you will possess:

• Bachelor's degree in life sciences or a related field (advanced degree preferred).
• Minimum 6 years of relevant work experience.
• Minimum 6 years of experience in drug development and/or clinical research, with at least 4 years of clinical trial project management involving a range of activities related to patient care, treatment administration, data collection, and ensuring the ethical and regulatory aspects of the trial are met.
• Strong knowledge of regulatory requirements and GCP.
• Excellent project management, leadership, and communication skills.
• Ability to analyze complex data and make informed decisions.
• Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language.
• Representative, outgoing and client focused.
• Ability to work effectively in a fast-paced challenging environment with a growing company.
• Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required.
• Strong presentation skills.

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-JC1

Federal Government client is seeking to identify suitable candidates to perform the role of Project Manager to support the agency to document business requirements, capture business needs, and design, create, evaluate, and document ICT solutions in new and existing ICT systems.

Project Managers support the agency by ensuring the high quality and consistent delivery of projects. Working under the broad direction of senior staff, they are responsible for managing the design, planning, development, implementation and evaluation of project outputs. They liaise and work with key stakeholders to foster partnerships, provide strategic advice and optimise the effectiveness of projects in I their area of responsibility. In performing a leadership role, they support innovation, changes in workplace practices and organises work in the context of competing priorities and strategic direction.

Estimated start date 01 September 2024

Initial contract duration 10 Months

Extension term 12 months

Number of extensions 2

Location of work ACT, QLD, VIC

Working arrangements Onsite

Security clearance Must be an Australian Citizen an able to obtain Baseline

Key duties may include, but are not limited to:

Project Manager – EL1

• manage, deliver and monitor projects that may have an organisation-wide impact.
• develop, manage and implement project plans and schedules in accordance with the agency’s project management framework and consider project interdependencies.
• collaborate with staff in immediate work area and with internal and external stakeholders.
• contribute to project design, governance arrangements and operational integration.
• ensure project deliverables and milestones are met on time and within budget.
• coordinate strategic planning for longer term project initiatives. • lead and manage staff and manage performance, attendance and health and wellbeing.
• develop staff capability through coaching, mentoring and succession planning. • provide expert advice and feedback to stakeholders and the agency's executive.
• research, review and evaluate projects in specific operational or technical areas.
• report on project outputs to stakeholders and oversee regular project reporting including status updates and exception reports.
• prepare and review written material including business cases, plans, reports and executive briefs and corporate documentation.
• undertake budget management, monitor expenditure and oversee procurement and contract management.
• identify, assess, manage, escalate, report and monitor project risks, issues and benefits, including developing treatment strategies.
• analyse project performance and coordinate quality management to ensure that project deliverables are fit for purpose and meet client needs.
• support innovation, manage and lead change and significantly contribute to business improvement strategies.
• develop and manage key stakeholder relationships and expectations to deliver projects.
• represent the work area or agency at external and cross-agency forums, including conferences and meetings. • exercise delegations appropriate to role in accordance with legislation and guidelines.

Senior Project Manager – EL2

• manage, lead and deliver projects that may have an agency wide impact.
• develop, implement and evaluate project plans and schedules in accordance with the agency’s project management framework and consider project interdependencies.
• collaborate with staff in immediate work area and with internal and external stakeholders.
• oversee project design, governance arrangements and operational integration.
• ensure project deliverables and milestones are met on time and within budget.
• lead strategic planning for longer term project initiatives.
• provide high level strategic advice and feedback to stakeholders and the agency's executive.
• research, review and evaluate projects within a section or specialist area.
• report on project objectives and outputs for presentation to the executive, and oversee ongoing project reporting.
• oversee, review and advise on written material including business cases, plans, reports, executive and ministerial briefs and corporate documentation.
• plan, manage and monitor financial budgets and oversee the management of contracts, procurement, resources and expenditure.
• identify, assess, manage, escalate, report and monitor project risks, issues and benefits, including developing treatment strategies.
• analyse project performance and oversee quality management to ensure that project deliverables are fit for purpose and meet client needs.
• drive innovation, manage and lead change, and actively contribute to and implement the agency’s strategic direction.
• engage, negotiate and manage key strategic stakeholder relationships to deliver projects and respond to changes in needs and expectations.
• represent and negotiate on behalf of the agency to advance the agency's interests at external, cross-agency, inter-jurisdictional and other forums.

Project Manager – EL1

• apply knowledge and skills in project and program management frameworks.
• understand the audience and context and effectively tailor communication and communication styles.
• develop and manage key stakeholder relationships and expectations.
• demonstrate personal resilience and manage challenging and sensitive situations.
• plan strategically and prioritise workload for self and teams to accomplish business outcomes.
• make decisions based on professional judgement, risk evaluation and in the context of the environment.
• collaborate with others.

Senior Project Manager – EL2

• apply knowledge and skills in project and program management frameworks

• understand the audience and context, anticipate responses and effectively tailor communication and communication styles

• develop and manage key strategic stakeholder relationships

• demonstrate personal resilience and apply well developed influencing, negotiation, conflict resolution and mediation skills

• demonstrate highly developed strategic planning skills to determine work priorities and deliver business outcomes

• make balanced decisions using professional judgement, risk evaluation and in the context of ambiguity and a changing environment