What are the responsibilities and job description for the Executive Director, Clinical Operations position at Merus?
Description
At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody technologies (Multiclonics®), to discover and develop innovative new medicines for patients with cancer. Working at Merus will give you the opportunity to join us in our mission of closing in on cancer. We are a global and diverse team of highly qualified professionals who care deeply about making a difference in patients’ lives. We have bold aspirations, because the need is great and the patients are waiting. Join us and make an impact.
Your role
Merus is seeking an Executive Director, Clinical Operations to provide strategic leadership and operational oversight for all clinical trial activities in our early phase organization. Ensuring they are conducted efficiently, effectively and in compliance with regulations. The role at Merus involves managing the early phase Clinical Operations team, fostering collaboration cross-functionally and supporting execution of our early phase clinical programs, ensuring inspection readiness across them. This position will be reporting to the Vice President of Clinical Operations.
In this role you will:
- Provide leadership, strategic oversight and guidance of the clinical operations organization, ensuring corporate goals, timelines and quality objectives are met.
- Lead across the clinical operations value chain, with respect to study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
- Promote integration of clinical operations knowledge and expertise into all applicable clinical development activities, including product development plans, study protocols, quality plans, clinical supply logistics, database creation & execution and data review.
- Implement, oversee and maintain responsibility for key performance indicators and ensure successful execution of clinical trials according to established timelines and compliance standards.
- Maintain considerable organizational awareness including elevating and maintaining strong inter-department relationships, accelerating business priorities, maximizing cross-functional communication to deliver goals, timelines, quality and budget standards.
- Represent clinical operations and actively provide updates as required to key internal and external stakeholders.
- Serve as first point of contact for Clinical Operations staff in early phase organization, support and develop their professional growth and success.
- Set strategic direction for vendor selection, management and oversight including detailed review and implementation of vendor oversight plans.
- Proactively identify and mitigate risks associated with clinical trial execution.
Your profile
We are looking for a candidate with:
- Bachelor's degree, advanced degree in Biomedical Sciences, Life Sciences, or a related field
- A background in Oncology is preferred
- Have at least 15 years of professional drug development experience, primarily in Clinical Operations, with a minimum of 5 years of leadership experience, including people management experience, preferably in a matrix environment. Global people management experience desirable.
- Prefer working in a high growth, dynamic, fast paced environment
- Proven experience leading across the clinical operations value chain, with a record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
- Experience in creating process documents, work instructions, plans, Standard Operating Procedures (SOPS), as well as building and driving an overall compliant and inspection ready environment including motivating the team towards a successful outcome
- Experience with early and late phase global drug development and BLA/NDA filing is required; experience in developing protocols, Investigator Brochures, clinical study reports, INDs, as well as other clinical, regulatory, and safety documents required
- Willing to travel globally to support site engagement initiatives across clinical trials
- Strong proficiency in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint)
- Expert knowledge of GCP, ICH guidelines, and clinical documentation requirements
- Familiarity with clinical systems including Veeva Vault, eTMF, RAVE, and SharePoint
- Strong attention to detail with excellent organizational skills and the ability to manage multiple priorities
- Clear and professional written and verbal communication skills
Our offer
We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to join us as we close in on cancer – everything you do matters at Merus.
About Merus
Merus is developing best-in-class therapeutics to treat and potentially cure cancer patients. Our most advanced development programs use the Biclonics® format. Biclonics® are capable of simultaneously attacking tumors in multiple ways. For example by activating the immune system to kill tumor cells and directly inhibiting tumor cell growth and survival pathways.
Working at Merus offers opportunity to grow and develop a career that offers both individual and company success. You have the chance to make an impact within the oncology field by being part of the development of bispecific antibody therapies (Biclonics®) to help fight cancer. Merus’ Head Quarters are located in The Netherlands, with offices in the US and collaborators around the world. As of 2016 we are listed on NASDAQ and over a period of 10 years we have several candidate drugs in clinical trials. For more information, please visit www.merus.nl
Working at Merus offers opportunity to grow and develop a career that offers both individual and company success. You have the chance to make an impact within the oncology field by being part of the development of bispecific antibody therapies (Biclonics®) to help fight cancer. Merus’ Head Quarters are located in The Netherlands, with offices in the US and collaborators around the world. As of 2016 we are listed on NASDAQ and over a period of 10 years we have several candidate drugs in clinical trials. For more information, please visit www.merus.nl
