Associate Director, Investigator Engagement at Lilly

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

14 Jul, 26

Salary

0.0

Posted On

15 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical trial management, Investigator engagement, Leadership, Good clinical practice, Regulatory compliance, Budget management, Strategic planning, Team development, Performance management, Problem solving, Communication, Vendor oversight, Risk management, Clinical development, Stakeholder management

Industry

Pharmaceutical Manufacturing

Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: The Associate Director / Director, Investigator Engagement is responsible for leading and managing a team of Clinical Research Leads (CRLs and rCRLs; Investigator Engagment Team) within a defined geography, and for collaborating with business partners to ensure clinical trials/studies across all therapeutic areas are executed in accordance with the scientific objectives, country-specific clinical trial strategy, timelines, budget, and local requirements. The Associate Director / Director, Investigator Engagement is accountable for ensuring consistent high quality interactions with, and timely robust performance of, global clinical trial sites and vendors. The Associate Director / Director, Investigator Engagement is also responsible for recruitment, training and development of the Investigator Engagement Team who are responsible for comprehensive Investigator management, inclusive of the delivery of Investigator performance metrics, on time database locks, and inspection readiness. Additional local responsibilities may be required as needed/appropriate for the local geography. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Clinical Investigator Management Accountable for clinical trial execution within country(ies) of responsibility across all Therapeutic Areas. Responsible for invesstigator qualification and enrollment performance Ensure on time delivery of database locks within the region/country (ies) Provide vendor oversight of delegated responsibilities for site monitoring activities of trial within the country (ies); drive routine discussions with a focus on performance, ensure milestone delivery with quality Understanding and knowledge of local treatment pathways to support targeted feasibility as required. Input into strategic allocation of trials as required Engage externally with all appropriate bodies (eg., MoH, ERBs, Pharma Associations) to understand country(ies) Clinical Trial regulatory environment(s) and ensure internal processes and procedures are maintained to reflect and comply with country requirements. Share with other functions as appropriate Drive real-time mitigation of issues and appropriate problem solving with proactive approach Manage Country Business planning and execution (Budget/capacity) Organizational Leadership Provide clear direction and align objectives of the Investigator Engagement Team with strategies for clinical development of portfolio assets Support flexibility of resources across therapeutic areas and geography (ies) while aligning to deliver on company priorities Responsible for development and implementation of applicable risk plans to ensure delivery of clinical trial enrollment commitments and database locks Drive a culture of high quality and inspection readiness Continuous monitoring of the performance / productivity of Investigator Engagement Team and identification of opportunities for improvement. Ensure implementation of affiliate and regional initiatives and shared learning as appropriate. Enable a culture of continuous improvement focused on outcomes, efficiency gains, and individual accountability Engage in the external clinical development community to influence external improvements, and drive the incorporation of external learnings into internal improvement efforts Seek opportunities to identify and apply innovative ideas and/or approaches within country (ies) of responsibility People Management and Development Effectively manage and coordinate an agile organization that continuously adapts to meet the needs of a changing portfolio Manage a diverse organization that fosters inclusion and innovation Coach CRLs and rCRLs to develop appropriate strategies to ensure positive customer experiences Establish performance plans, monitor and evaluate the performance of the CRLs and rCRLs Attract, develop and retain top talent in the Investigator Engagement organisation Minimum Qualification Requirements: Bachelor’s degree or equivalent work experience in a scientific field or health-related field 5 years experience in Clinical Trials/Development and good working knowledge of Good Clinical Practice Demonstrated leadership skills with ability to influence, achieve results through others and lead across the business. Other Information/Additional Preferences: Strong communication (both verbal and written) and language skills – ability to provide coaching to employees and communicate effectively up and down in the organization Demonstrated supervisory skills Strong organisational/planning skills Fluent in English Strong knowledge in country regulatory guidelines/requirements . Strong interpersonal skills Demonstrated decision-making ability Ability to develop and apply creative solutions Experience in working cross-culturally and with virtual teams Travel required (25-50%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

Responsibilities

The Associate Director leads and manages a team of Clinical Research Leads to ensure clinical trials are executed according to scientific objectives, timelines, and local regulatory requirements. They are responsible for investigator management, vendor oversight, and driving a culture of high quality and inspection readiness within their geography.