Associate Director Clinical Operations jobs at Incyte in Australia

Job Summary (Primary function)

The primary responsibilities of this position include assessing qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies.

This individual will ensure that clinical trials are conducted according to the approved protocol/protocol amendments and comply with Good Clinical Practice (GCP), Company SOPs and all applicable regulatory requirements.

The Senior CRA is a seasoned professional with wide-ranging experience and a thorough understanding of GCP and ICH principles. The experienced Senior CRA identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the Senior CRA will establish strong, positive relationships with both internal and external partners. This individual contributes to the determination, development and/or implementation of efficient and effective approaches to study site management.

Essential Functions of the Job (Key responsibilities)

·Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.

·Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements.

·Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.

·Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.

·Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.

·Ensures subjects’ rights, safety and well-being are protected.

·Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.

·Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.

·Assists Data Management in development, review and/or testing of eCRFs and eCRF Completion Guidelines. Also supports data validation and data cleaning procedures to ensure timelines are met.

·Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations.

·Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

·Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).

·Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.

·Ensures availability of non-clinical materials for sites.

·Demonstrates strong site relationships and ensures continuity of site relationships through all phases of the trial.

·Demonstrates an in-depth understanding of study protocols and related procedures.

·Contributes to CRA team knowledge by acting as process and/or system Subject Matter Expert (SME), sharing best practices; developing new process(es), when needed; making recommendations for continuous improvement

·Providing training/coaching/mentoring to other CRAs as needed.

·Assists in developing presentations for internal team and Investigator meetings.

·Assumes responsibility of and independently completes special projects, if assigned, with minimal monitoring management guidance.

·The follow items are only applicable for Ex-Us CRAs:

Prepares EC packages and submissions, notifications to Regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by supervisors.

Supports ADCO in providing CRO oversight for assigned studies

Qualifications (Minimal acceptable level of education, work experience, and competency)

·Position requires BA/BS preferably in the Life Sciences, or RN,

·Minimum of 5+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock

·Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials

·Demonstrated high level of monitoring skill with independent professional judgment

·Possess excellent understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements

·Strong knowledge of concepts of clinical research and drug development

·Strong working knowledge of EDC, IVRS and CTMS systems

·Proficient in the use of Microsoft Office

·Ability to work highly independently across multiple studies, projects and sites. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information.

·Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills

·Demonstrated ability to mentor/lead

·Works with high quality and compliance mindset

·Possess a valid driver’s license

·Must be willing to travel and spend 8-10 days /month on site.

·Ex-US: Proficient in speaking and writing English and the country language when applicable.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary Function):

Essential Functions of the Job (Key Responsibilities):

·Provide medical leadership and oversight for clinical studies in Australia, ensuring alignment with global strategy and scientific standards.

·Participate in site identification, collection and review of site documents, Informed Consent Form (ICF) adaptation, HREC submission, and regulatory applications, including support for amendments.

·Represent the medical function in site visits (including SIVs), and collaborate closely with investigators and study teams to ensure operational excellence.

·Work closely with external vendors (CROs, laboratories, etc.) and internal cross-functional teams (clinical operations, pharmacovigilance, biometrics) to support execution of global and regional studies.

·Monitor, review, and summarize clinical safety and efficacy data.

·Support the development and authorship of study protocols, clinical documents, and trial-related materials.

·Provide scientific input into study design from early development through late-stage trials, ensuring incorporation of local insights into global programs.

·Contribute to the TPOR program, including clinical protocol development and early-phase strategy.

·Build strong collaborative relationships with local and global stakeholders, including key opinion leaders and investigators.

Qualifications (Minimum Requirements):

·M.D. degree with clinical development experience in oncology and/or immunology/autoimmunity (Senior 8-years/ Executive 8+-years)

·Board certification or eligibility in oncology, hematology or an IAI-related specialty is preferred (dermatology, immunology).

·Prior experience in pharmaceutical or biotech industry is strongly preferred.

·Strong written and verbal communication skills in English.

·Demonstrated ability to work in cross-functional and multicultural teams.

·Experience engaging with clinical investigators and managing external partnerships.

·Strong leadership, organizational, and analytical skills with the ability to manage multiple priorities.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

Associate Director Clinical Operation is the Regional Clinical Operation (ReCO) tactical expert responsible to provide leadership and strategic oversight of the Incyte pipelines, provide adequate planning and operational delivery of assigned clinical studies, in accordance with the appropriate quality standards, including ICH/GCP standards, Incyte SOPs, Country operating guidelines and Country requirements, as applicable, in the territory assigned (Australia and New Zealand) (Territory).

Duties include but are not limited to: (1) direct/indirect management and support of Country Clinical Operations teams including providing inputs with regards to resource assignment, development, training, and performance review (2) oversight of programs/clinical studies to ensure their implementation and progress (3) a key partner with Development Operations (e.g Asset Leads and Global Clinical Trial Managers) and Development Operations senior management stakeholders, as required, in all aspects of drug development strategy and management.

Essential Functions of the Job (Key responsibilities)

Is responsible for the strategy building and planning, execution and oversight of Clinical Operation activities in the Territory.

Collaborates with Development Operations (eg. Asset Leads, Global Clinical Trial Managers) and Country representatives (eg. Medical Affairs) as appropriate to ensure continuous alignment on Country strategy, execution, follow-up and support for outsourced and in-house clinical studies in the Territory.

Acts as the Country Clinical Operations expert/point of contact for the Development Operations (eg. Asset Leads, Global Clinical Trial Managers) to support the timely and efficient site set-up and maintenance of outsourced and in-house clinical studies in the Territory.

Demonstrates ability in working in a matrix organization by partnering with Country Organizations, Development Operations and Clinical Development to identify investigators, clinical experts, cooperative groups, and build Country network that support pipeline development in all therapeutic areas in the Territory.

Represents Incyte externally and build relationships, including a master agreement of clinical trials, when possible, with key research institutions and investigators in the Territory.

Communicates and updates on regular basis on clinical trial activities and strategy in the Territory with Development Operations (eg. Asset Leads, Global Clinical Trial Managers) and ReCO Asia Pacific Head.

Assures Country inspection readiness by developing Country work instructions, procedures, SOPs, as needed and applicable by liaising with the respective relevant functions (e.g. Clinical QA) in the Territory.

Tracks Country KPI (e.g. Country enrolment target) to ensure high performance and implement corrective actions as needed in the Territory.

Provides Country inputs and contributes to the improvement of Development Operations SOPs and processes (Global, Regional and Country level).

Identifies gaps and lead and implement Country SOPs/WIs and processes in collaboration with other departments as needed.

Manages Country Clinical Operations resources based on activities and engagement (current and future pipeline development) in the Territoy.

Conducts performance reviews of direct reports with support as needed. Oversees proper handover and training documentation for internal monitoring activities.

Implements individual development plan of direct reports with support as needed.

Qualifications (Minimal acceptable level of education, work experience, and competency)

Minimum Bachelor of Science degree or equivalent degree

Minimum of 5-7 years’ experience working in Clinical Operations within the biopharmaceutical industries and/or Clinical Research Organization (‘CRO’) including a role of primary responsibility for clinical study execution and management.

Operational and direct managerial experience in the planning, executing and reporting of clinical studies.

Have experience in appropriate therapeutic areas; Oncology, Hematology, Inflammatory Diseases (preferable)

Experience in developing effective relationships with key investigators.

Language Proficiency

Have capabilities of business level languages: English.

Proven ability to manage multiple tasks simultaneously and to lead multi-disciplinary teams.

Good knowledge of GCP, clinical study design, statistics, regulatory processes, inspection readiness and drug development process.

Proven ability to work in a matrix organization.

Excellent organizational, problem-solving, and written/verbal communication/presentation skills.

Goal oriented, self-starter with proven ability to work independently in accordance with stated timelines and quality.

Effective organizational and time management skills.

Proven flexibility and adaptability.

Available for domestic and international travel.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .