Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.
Why ADC Therapeutics
ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl) has been approved in the United States and in the European Union. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients.
We consist of nearly 300 dedicated employees, all focused on patient care and driven by purpose who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!
To learn more about ADC Therapeutics, please visit us at adctherapeutics.com and follow us on LinkedIn.
What You’ll Do:
The Global Clinical Trial Lead will successfully oversee and be responsible for the internal and external global operations and quality project management (i.e., adherence to and balance of scope, time, budget) for one or more assigned clinical trials throughout the trial’s life cycle (e.g., planning, development, initiation, maintenance, closeout, reporting). This person acts and serves as the primary study leader and main point of contact and communication for all internal and external stakeholders involved in study planning, development, initiation, execution, closure, and reporting. This involves generating robust and accelerated delivery plans (with focus on performance) and delivering these to target or stretch thresholds. This individual might also supervise and mentor other Clinical Trial Leads.
Location: our preference is NJ based with the ability to come into the New Providence office as needed
Job Responsibilities:
- Accountable and responsible for ensuring all assigned studies and assigned study resources adhere to approved scope, timelines, and budget.
- Oversee and ensure assigned studies are being executed with the utmost quality, adhering to SOPs, ICH, GCP and other national and local regulations, as applicable.
- Develops, reviews, modifies as needed and adheres to contractually approved study timelines, deliverable, and milestones.
- As the CTL, leads the study team meeting and actively partners to build relationships and collaborates with internal and external stakeholders to ensure operational excellence in study execution.
- Encourages others within study team to seek alternative perspectives and develop solutions.
- Oversees efforts in study start-up including proper and timely country and investigational site feasibility activities, site selection, preparation and follow-up of site regulatory packages in coordination with other internal key stakeholders (i.e. CTAs, Regulatory, etc.).
- Able to appropriately and succinctly communicate and, when necessary, escalate challenges, issues, risks as well as mitigation and/or resolution approaches to upper management.
- Responsible for managing the clinical study budget by adhering to final budgets, and that any increase in budget due to out-of-scope activities are identified and handled as appropriate. The CTL is responsible for oversight of change orders, and contractual agreements and mitigating/resolving financial risks/issues, when necessary.
- Develops, reviews, obtains approvals for change orders & other budget modifications.
- Responsible for the preparation of materials for internal governance and/or financial review cycles.
- Oversees successful mitigation and resolution of all risks, issues, and/or challenges identified throughout the study.
- Independently develops study related documents including but not limited to: Study Manuals, project tools, project plans, tracking tools, informed consents. Provides expert clinical operational input in development of the protocol, case report forms, case report form guidelines.
- Establishes tracking metrics to monitor clinical trial and team progress toward trial goals/milestones/timelines.
- Regularly collates, prepares, summarizes, and presents operational study health and financial status to GCO leadership.
- Primary point of contact for all study-level Health Authority audits, inspections, responses, follow-up, and lessons learned.
- Partner with Data Management and Clinical Science to develop the data cleaning strategy. When needed, assists with clinical data review including but not limited to in-house CRF review, query resolution, patient profile review, etc.
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff and Sr. Leadership with a high level of proficiency.
- Oversees and may directly supervise the work of Global Clinical Study Associates (CTAs) who provide administrative support to clinical studies.
- Provides guidance to and may manage junior Clinical Trial Leads, as necessary and applicable.
- May participate in hiring processes of new potential ADCT resources.
- May participate in the selection of Clinical Research Organizations (CROs) and other 3rd party entities/vendors being leveraged to support successful execution of study.
- May participate in technology vendor selection, end-user requirements gathering, user acceptance testing, system implementation activities at study-level.
- May support Global Clinical Program Lead and/or Global Clinical Operations Lead with strategic initiatives and/or proposal development activities.
- Up to 10% travel, as required.
Who You Are:
- Bachelors required, advanced degree with scientific or health-care training preferred.
- Minimum of 10+ years of pharmaceutical development experience, with a minimum of 3-years global clinical trial leadership experience.
- Hematology and/or Oncology experience is required.
- Experience working in pharmaceutical industry demonstrating expertise in the areas of early and late-stage clinical development and execution in US and non-US based clinical studies; experience in strategic planning is a plus.
- Proficiency in overseeing early-stage clinical studies, particularly Phase-I trials.
- Demonstrate stellar organization, verbal, and written communication skills.
- Experience developing, implementing, and leading a cross-functional study team and ensure adherence to SOPs, processes, rules and regulations.
- Effectively able to collaborate with and successfully manage external 3rd party entities, vendors, and CROs.
- Able to mentor and develop assigned study personnel, as applicable.
- Possess a deep understanding of financial management including experience reviewing and successfully managing study-level budgets, change orders, and other financial contracts and activities.
- Solid working knowledge of FDA & ICH/GCP regulations and guidelines.
- Ability to work in a team environment, meet agreed upon deadlines, and prioritize and balance work delegated from, potentially, multiple internal and external stakeholders.
- Proficiency in using Microsoft Suite (e.g., Word, Excel, Outlook, PowerPoint, Project).
- Focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
- Demonstrate a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the company culture, and positive interactions with customers and team members including good interpersonal skills.
- Work proactively and independently, be detailed oriented and possess emotional intelligence and good problem-solving skills.
ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.
