Clinical Study Manager

Clinical Operations · Montgomery County, Maryland
Department Clinical Operations
Employment Type Full-Time
Minimum Experience Manager/Supervisor

The Company


Vaccitech plc is a fast-growing biotech company. At only five years old we already have a development portfolio of six products, a partnered product that is in commercial production that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly-listed clinical stage biopharmaceutical company that spun out of the University of Oxford’s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.


In December 2021 Vaccitech acquired Avidea Technologies with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us US operational presence in Maryland, complements Vaccitech’s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. From March 2022 Vaccitech's UK headquarters will be moving to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.


The role

 

The Clinical Study Manager will be responsible for the management and oversight of all aspects of allocated studies in accordance with internal SOPs, ICH GCP, relevant guidelines and all applicable laws and regulations. This will include study team coordination and leadership and the oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality. You will hold responsibility for preparation of study documentation and coordination of document review, e.g. protocols, IBs, DSURs, ICFs, CSRs and will be responsible for the selection and oversight of assigned CROs, vendors or contract monitors (CRAs), as appropriate. You will also select clinical sites in collaboration with other members of the Vaccitech study team or CROs, as appropriate.


The Clinical Study Manager will be required to conduct the periodic co-­‐monitoring with contract CRAs or CROs as necessary for each study, to ensure high quality monitoring and site management and to set up and management of clinical contracts (including Clinical Site Agreements). You will also be required to coordinate IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Head (or CRO if delegated) for regulatory submissions.

 

Experience and Qualifications


The successful candidate will be degree educated in a scientific discipline and have clinical study management experience within a pharmaceutical, biotech or a CRO company. You will have experience in the oversight of external vendors (CROs, central labs, imaging vendors, etc.). The ability to travel in the UK and abroad periodically if needed is essential.

Experience in early phase (I-­‐II) studies, GMO and CRA monitoring experience are desirable though not essential. Infectious Diseases and Oncology experience would be a distinct advantage.

 

What We Can Offer


Vaccitech is a great place to work. We encourage an entirely flat structure with an open door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer employer funded health, dental and vision insurance; a 401k retirement plan; career development opportunities and paid time off (PTO). Salary will be commensurate with experience.


Notice to Recruiters


Vaccitech’s internal Talent Acquisition leads recruitment and employment for Vaccitech. Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes. Vaccitech operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Vaccitech’s TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.

Thank You

Your application was submitted successfully.

  • Location
    Montgomery County, Maryland
  • Department
    Clinical Operations
  • Employment Type
    Full-Time
  • Minimum Experience
    Manager/Supervisor