Senior Clinical Operations Manager Biopharma Careers Sydney, NSW, AU

Job Description Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

At AbbVie, we don't just deliver medicines. We advance science that transforms patient outcomes.

We're seeking an accomplished Senior Clinical Operations Manager to join our Clinical Operations team in Sydney and play a critical leadership role in the successful delivery of innovative clinical research programs across Australia and New Zealand. This is an opportunity provide strategic and operational leadership across clinical studies in ANZ and to influence the future of clinical development while leading high-performing teams, collaborating with global stakeholders, and helping bring breakthrough therapies to patients faster.

This role is ideal for an experienced Clinical Operations professional who combines scientific credibility with strong people leadership and business acumen. If you're ready to make a broader impact, we'd love to hear from you.

KEY DUTIES AND RESPONSIBILITIES

• Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
• Provide leadership and oversight to the clinical research team including, but not limited to: performs accompanied site visits (on-site and off-site)
• accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders
• conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel and broader team
• addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics. Utilises AbbVie systems and tools to proactively address performance and mitigate risks and issues
• Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and / or delivery of their assigned study activities of their assigned studies.
• Supports, trains and oversees assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies.
• Prepare and follow up on site and country audits, CAPA preparation and implementation.
• Accountable for resource management for assigned team and may be responsible for resource management of entire countries. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provides solutions.
• Accountable for the budget management and payments for assigned studies, as applicable
• Leads and supports the team to understand the business strategy and vision. Supports team to connect strategy to execution and promote collaboration with stakeholders to effectively deliver pipeline.
• Drives and implements change through effective communication and management
• Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
• Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials.
• May participate and/or lead global/local task forces and initiatives. Responsible for activities as assigned by Country Clinical Operations Manager (CCOM). Proactively identifies opportunities at local/global levels and proposes solutions to create efficiencies and streamline/improve processes.
• Oversight and delivery of country and site feasibility activities in alignment with local and global strategy and expanding AbbVie's footprint within the country.
• Supporting CCOM may be responsible for functional budget planning and oversight of expenses across country/ies.
• Supporting CCOM in driving insightful and impactful interactions with key external stakeholders and agencies.
• May be assigned on or multiple TA responsibilities within country/ies. Support training and monitoring for the team. Develop and implement strategies to support pipeline execution. Collaborate with local and global cross functional partners including Medical Affairs or commercial brand teams as appropriate.
• Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in conducting clinical research.
• Stay abreast of new and/or evolving local regulations, guidelines and policies
• Report any adverse event within 24 hours as per AbbVie's policies and procedures.
• Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie's codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties, as requested.

Qualifications

• Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy).
• Minimum 5 years monitoring experience plus at least 1 year of direct line management experience.
• Advanced interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally.
• Demonstrates flexibility to changing requirements with the ability to establish and leverage relationships and trusted partnerships.
• Demonstrated proactive and positive team player.
• Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
• Exhibits strong planning and organizational skills.
• Experience across multiple therapeutic areas and study phases
• Excellent mentoring and coaching skills. Has the ability to provide transparent and timely feedback to raise the bar on individual and team performance.
• Drives innovation and continuous process improvement.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Deals comfortably with risk and ambiguity, changing courses when needed.
• Able to make timely, high-quality decisions based on available data and information.
• Ability to work independently, adapt and move quickly, and take initiative/ownership.
• Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information

AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion.

It is AbbVie's policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

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WAYS WE WORK All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.

Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn't work and get on to what does.

Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.

Clear & Courageous; Open, honest . click apply for full job details

AbbVie, a leader in aesthetic medicine, seeks a Medical Advisor to join the ANZ Medical Affairs team in Sydney for a 12-month contract. You will influence medical strategy, engage with leading clinicians, and shape evidence-based aesthetic medicine across Australia and New Zealand.

You will interact with key opinion leaders, clinicians, and experts to drive education, scientific engagement, and clinical excellence, contributing to compliant medical decision-making.

Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on LinkedIn, Facebook, Instagram, XandYouTube.

Job Description We are seeking a Medical Advisor to join our ANZ Medical Affairs team in Sydney for a 12 month contract. This is a role where you'll influence medical strategy, partner with some of the region's leading aesthetic physicians and specialists, and help shape the future of evidence-based aesthetic medicine across Australia and New Zealand.

You'll work directly with key opinion leaders, leading injectors, clinicians and emerging experts across ANZ to drive education, scientific engagement and clinical excellence. You'll have genuine influence over medical strategy, stakeholder engagement and medical education initiatives that support some of the most recognised brands in aesthetics.

If you're passionate about scientific exchange, physician education and building trusted relationships with healthcare professionals, this is an opportunity to make a meaningful impact in one of the most dynamic areas of healthcare.

KEY DUTIES AND RESPONSIBILITIES

• Work closely with the Associate Director, Medical Affairs, ANZ, to define Medical Affairs priorities, strategy, and execution plans for the therapeutic area.
• Lead the development and implementation of the Medical Affairs plan, ensuring alignment with regional Medical Affairs priorities, the International Therapeutic Lead, and relevant local business objectives.
• Translate the medical strategy into clear, prioritised field activities and stakeholder engagement plans across ANZ.
• Take accountability for the delivery, quality, and impact of Medical Affairs initiatives within the assigned therapeutic area.
• Develop a comprehensive understanding of the ANZ clinical landscape, including treatment pathways, standards of care, stakeholder needs, unmet medical needs, and emerging scientific trends, to inform strategy and execution.
• Provide medical leadership and strategic direction to Medical Science Liaison activities and other Medical Affairs initiatives, ensuring alignment with the overall medical plan.
• Act as a medical resource for internal stakeholders, providing objective medical insight and perspective to support sound, compliant business decisions.
• Lead high quality, non promotional scientific exchange with healthcare professionals to improve understanding of Allergan Aesthetics products, supporting evidence, appropriate use, and relevant therapeutic areas.
• Lead and facilitate scientific education and training for physicians and other healthcare professionals, building clinical expertise, confidence, and understanding of current and future therapeutic options.
• Provide balanced, accurate, and credible medical information to support evidence based clinical decision making.
• Lead the development, planning, and delivery of medical education initiatives, speaker programs, advisory activities, scientific meetings, and other external engagements in accordance with applicable policies and local requirements.
• Set the scientific direction and medical content for educational activities, ensuring that materials and presentations are medically accurate, balanced, evidence based, and compliant.
• Serve as a trusted senior scientific resource for healthcare professionals, KOLs, and other external stakeholders.
• Support the development of physicians' expertise and confidence in the appropriate use of Allergan Aesthetics products through scientific education and professional development initiatives.
• Maintain a high level of therapeutic area expertise and remain current with relevant scientific, clinical, and practice developments.
• Lead the identification, prioritisation, and engagement of key opinion leaders, researchers, physicians, nurses, administrators, specialty societies, and other stakeholders who influence the scientific and clinical landscape.
• Develop and execute strategic KOL engagement plans that support the Medical Affairs strategy and strengthen long term, trust based relationships.
• Lead stakeholder and territory planning across ANZ, including the identification of priority stakeholders, engagement opportunities, unmet medical needs, and opportunities to advance medical understanding.
• Lead local, regional, and national scientific activities with key stakeholders, including the development of objectives, agendas, engagement plans, and measures of success.
• Identify emerging leaders with relevant specialty interests, and lead appropriate educational initiatives to foster long term relationships and support the future development of the therapeutic area.
• Maintain effective relationships with physicians, administrators, and representatives of relevant specialty societies.
• Interpret and communicate stakeholder feedback, clinical practice insights, and outcomes from external engagements to inform Medical Affairs strategy and planning.
• Manage a predominantly customer facing role, with approximately 65% of time dedicated to interaction with KOLs, healthcare professionals, and other external stakeholders. Travel throughout ANZ is expected as required.
• Keep current on scientific, clinical, and market developments in ANZ, the broader Asia Pacific region, and globally.
• Attend key medical congresses and scientific forums locally to strengthen medical knowledge and external relationships.
• Gather and communicate external insights, competitor intelligence, and scientific observations to inform Medical Affairs strategy and planning.
• Contribute to the scientific development of promotional and educational materials by providing accurate and balanced medical advice, where appropriate and compliant.
• Report any adverse event within 24 hours as per Allergan's policies and procedures.
• Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to Allergan's / AbbVie's internal codes of conduct and compliance processes.
• Other ad hoc duties such as administrative duties, as requested.

Qualifications

• Science degree. B Pharm, Nursing, Pharm D, MSc or PhD preferred.
• Minimum 5 years of post qualification work experience; experience working in pharmaceutical or medical related industry, overseas education or work experience desirable
• Minimum 2 years' experience working in a medical affairs team in the medical device or pharmaceutical science industry with previous experience in a customer facing role highly regarded
• Strategic thinking and leadership skills
• Advanced stakeholder engagement and influencing skills
• Excellent scientific communication and presentation skills
• Strong analytical skills, with ability to critically evaluate and effectively communicate key clinical data
• Ability to quickly learn and communicate clinical and non clinical technical information effectively to individuals with varying degrees of scientific acumen
• Ability to work cross functionally in a matrix structure, supporting multiple stakeholders
• High level of professional integrity and understanding of compliance requirements
• Ability to work independently with sound judgment and accountability
• Strong project management skills
• Strong listening skills with the ability to capture and synthesize insights
• Experience in clinical research including phase IV studies desirable
• Intermediate skills in Microsoft Suite, particularly PowerPoint
• Ability to travel about 50% of the work time throughout ANZ

Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

WAYS WE WORK

• All For One Abbvie;We weigh all decisions against the common good . click apply for full job details

Company Description About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description At AbbVie, we don't just run clinical trials. We help bring life-changing medicines to patients who need them most.

We're seeking an experienced Clinical Research Associate II to join our Clinical Operations team and play a critical role in delivering innovative clinical studies across a diverse and exciting portfolio. This is an opportunity to partner with leading investigators, influence study success, and contribute to therapies that have the potential to transform patient outcomes. You'll join a high-performing team that values curiosity, accountability, collaboration and continuous learning and be the trusted AbbVie representative for your assigned clinical sites, helping ensure the successful delivery of clinical research while maintaining the highest standards of quality, compliance and patient safety.

If you're an experienced CRA looking for greater ownership, meaningful scientific engagement, and the chance to work with one of the world's leading biopharmaceutical companies, we'd love to hear from you.

KEY DUTIES AND RESPONSIBILTIES

• Act as the primary Sponsor point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening AbbVie's positioning.
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
• Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance, protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• Advanced understanding of site engagement and ability to customise site engagement strategy for assigned studies.
• Gather local/site insights and utilise site engagement tools to report/track progress and measure impact of that strategy.
• Connect the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient's disease journey.
• Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
• Mentor and train less experienced CRAs on various aspects of work and provides input into their development.
• Responsible for activities assigned by manager and participate in global/local task forces and initiatives.
• Proactively responsible for continuous risk-assessment, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Resolves site risk signals while having a robust understanding of site processes to drive study execution, ensuring preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Audit and regulatory inspection readiness at always assigned clinical site.
• Manages investigator payments as per executed contract obligations, as applicable.
• Report any adverse event within 24 hours as per AbbVie's policies and procedures.
• Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie's codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties, as requested.

Qualifications

• Bachelor's degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
• Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials.
• Familiarity with risk-based monitoring approach, onsite and offsite monitoring.
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
• Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
• Ability to use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Self-motivated individuals focused on delivering timely and quality outcomes in a fast-paced environment.
• Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.

Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

WAYS WE WORK

• All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
• Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn't work and get on to what does.
• Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
• Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
• Make Possibilities Real; We question with endless curiosity. We're never satisfied with good enough, patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.

AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.

All AbbVie employees are responsible for maintaining the Company's reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law.

. click apply for full job details

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

At AbbVie, we believe better health outcomes start with trusted information.

We're looking for a Medical Review Specialist to join our Medical Affairs team in Sydney for a 12 month Max Term Contract, 3 days per week, and play a pivotal role in ensuring the scientific accuracy, integrity and compliance of materials across our diverse therapeutic portfolio. This is a unique opportunity for a healthcare, scientific, medical affairs or regulatory professional who enjoys partnering with stakeholders, navigating complex decisions and influencing outcomes through expertise rather than authority.

You'll work at the intersection of Medical Affairs, Regulatory Affairs and Commercial, helping teams bring high-quality, compliant communications to healthcare professionals and patients across Australia and New Zealand.

KEY DUTIES AND RESPONSIBILITIES

• Provide expert advice, guidance and training on the relevant processes, Code and regulatory requirements relating to review of promotional & non-promotional materials and activities for the assigned therapeutic portfolio.
• Conduct efficient and high-quality medical and regulatory review of materials according to internal SOPs and external laws, regulations, and Codes.
• Partner strategically with both Commercial and Medical teams, to support consistency with the necessary compliance standards, while aligning with the broader business and therapeutic strategy.
• Collaborate closely with internal stakeholders, fostering a partnership approach, and offering expert advice and recommendations to optimise content and ensure that medical accuracy and regulatory compliance aspects are embedded in materials.
• Support the team in driving a consistent approach to medical and industry code review across the business. Includes attendance of regular group meetings initiated by the Head of Medical Affairs Communications.
• Develop and maintain Code and review-process related internal resources, including SOPs and guidance documents to facilitate compliance and clarity for stakeholders
• Provide specialised medical/scientific information support to the commercial teams in defence of the brands, including response to Code complaints and initiation of complaints.
• Support Commercial as well as Learning & Development teams with medical/scientific training associated with products within the assigned therapeutic portfolio in collaboration with Medical colleagues and Product Managers.
• Participate in cross-functional approaches to projects and product issues within assigned therapeutic portfolio.
• Coordinate label update impact assessments to support the material owners and brands in the relevant updates to product-related materials.
• Maintain up-to-date knowledge of developments in relevant regulatory and Code requirements, as well as the clinical/scientific body of evidence within assigned therapeutic portfolio.
• Provide second-line support if required, in the provision of specialised medical/scientific information to healthcare professionals and consumers.
• Report any adverse event within 24 hours as per AbbVie's policies and procedures.
• Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie's internal codes of conduct and compliance processes.
• Other ad hoc duties such as administrative duties, as requested.

Qualifications

• Pharmacy, Life Sciences, or Biomedical degree (e.g. Pharmacology major)
• Medicines Australia Code of Conduct CEP Accreditation - Program 1 (or in progress)
• Minimum 1 year in pharmaceutical, healthcare, or medical communications environment
• Understanding of and experience in pharmaceutical/regulatory Code-compliant review processes and promotional material standards
• Materials and activities and ability to apply them to real-world materials and communication channels.
• Critical and thorough appraisal of the scientific literature, including study design, endpoints, and limitations. Competence in interpreting statistical results, forest plots, integrated safety data, and exposure-adjusted event rates.
• Strategic mindset with a focus on compliant solutions.
• Strong decision-making and prioritisation skills.
• Ability to search scientific information within the literature.
• Ability to navigate and adapt to ambiguity and risk.
• Demonstrated ability for both problem solving and consolidation of medical facts and clinical data.
• Effective communication skills considering appropriate context, timing and method. Ability to effectively communicate medical and scientific information to audiences with varying medical/scientific understanding.
• Strong negotiation and diplomacy skills - able to uphold compliance while maintaining constructive relationships
• Attention to detail with a commitment to continuous learning and adaptability
• Familiarity with using Veeva PromoMats/Medical
• Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information

AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status.

Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

WAYS WE WORK

• All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
• Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn't work and get on to what does.
• Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
• Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
• Make Possibilities Real; We question with endless curiosity. We're never satisfied with good enough, patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT

AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.

AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.

All AbbVie employees are responsible for maintaining the Company's reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law.

Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

Company Description About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description At AbbVie, we don't just deliver medicines. We advance science that transforms patient outcomes.

We're seeking an accomplished Senior Clinical Operations Manager to join our Clinical Operations team in Sydney and play a critical leadership role in the successful delivery of innovative clinical research programs across Australia and New Zealand. This is an opportunity provide strategic and operational leadership across clinical studies in ANZ and to influence the future of clinical development while leading high-performing teams, collaborating with global stakeholders, and helping bring breakthrough therapies to patients faster.

This role is ideal for an experienced Clinical Operations professional who combines scientific credibility with strong people leadership and business acumen. If you're ready to make a broader impact, we'd love to hear from you.

KEY DUTIES AND RESPONSIBILITIES

• Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
• Provide leadership and oversight to the clinical research team including, but not limited to: performs accompanied site visits (on-site and off-site)
• accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders
• conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel and broader team
• addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics. Utilises AbbVie systems and tools to proactively address performance and mitigate risks and issues
• Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and / or delivery of their assigned study activities of their assigned studies.
• Supports, trains and oversees assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies.
• Prepare and follow up on site and country audits, CAPA preparation and implementation.
• Accountable for resource management for assigned team and may be responsible for resource management of entire countries. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provides solutions.
• Accountable for the budget management and payments for assigned studies, as applicable
• Leads and supports the team to understand the business strategy and vision. Supports team to connect strategy to execution and promote collaboration with stakeholders to effectively deliver pipeline.
• Drives and implements change through effective communication and management
• Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
• Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials.
• May participate and/or lead global/local task forces and initiatives. Responsible for activities as assigned by Country Clinical Operations Manager (CCOM). Proactively identifies opportunities at local/global levels and proposes solutions to create efficiencies and streamline/improve processes.
• Oversight and delivery of country and site feasibility activities in alignment with local and global strategy and expanding AbbVie's footprint within the country.
• Supporting CCOM may be responsible for functional budget planning and oversight of expenses across country/ies.
• Supporting CCOM in driving insightful and impactful interactions with key external stakeholders and agencies.
• May be assigned on or multiple TA responsibilities within country/ies. Support training and monitoring for the team. Develop and implement strategies to support pipeline execution. Collaborate with local and global cross functional partners including Medical Affairs or commercial brand teams as appropriate.
• Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in conducting clinical research.
• Stay abreast of new and/or evolving local regulations, guidelines and policies.
• Report any adverse event within 24 hours as per AbbVie's policies and procedures.
• Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie's codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties, as requested.

Qualifications

• Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy).
• Minimum 5 years monitoring experience plus at least 1 year of direct line management experience.
• Advanced interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally.
• Demonstrates flexibility to changing requirements with the ability to establish and leverage relationships and trusted partnerships.
• Demonstrated proactive and positive team player.
• Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
• Exhibits strong planning and organizational skills.
• Experience across multiple therapeutic areas and study phases
• Excellent mentoring and coaching skills. Has the ability to provide transparent and timely feedback to raise the bar on individual and team performance.
• Drives innovation and continuous process improvement.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Deals comfortably with risk and ambiguity, changing courses when needed.
• Able to make timely, high-quality decisions based on available data and information.
• Ability to work independently, adapt and move quickly, and take initiative/ownership.
• Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion.

It is AbbVie's policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

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WAYS WE WORK All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.

Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn't work and get on to what does.

Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.

Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes . click apply for full job details