Global Head - Clinical Operations

Owkin

Owkin

Operations
Nantes, France · Remote
Posted on Friday, November 10, 2023

About us

Owkin is an AI biotechnology company that uses AI to find the right treatment for every patient. We combine the best of human and artificial intelligence to answer the research questions shared by biopharma and academic researchers. By closing the translational gap between complex biology and new treatments, we bring new diagnostics and drugs to patients sooner.

Owkin has raised over $300 million and became a unicorn through investments from leading biopharma companies (Sanofi and BMS) and venture funds (Fidelity, GV and BPI, among others).

Owkin is seeking the best and brightest to join our fast-growing and dynamic team.

About the role:

Owkin is dedicated to pioneering ground-breaking therapies for patients facing unmet medical challenges. We are seeking a Head of Clinical Operations to oversee the effective execution of clinical studies and manage the activities of Contract Research Organisations. Additionally, this role will involve the development of in-house expertise and the internalisation of novel processes, methods, and tools.

This position will be based at our Paris/London office (or remote in UK/EU) You will be responsible for clinical study design, clinical trial protocol development in conjunction with our Chief Medical Officer and the clinical trial team.

On a daily basis, you will be leading our clinical trial team and external vendors to ensure Owkin’s clinical operations are within budget, timelines and overall quality are met to an industry leading standard.

In particular, you will:

  • Supervise the operational aspects of clinical studies conducted by CROs, including but not limited to clinical study design (with Medical and data science teams), clinical study start-up, site selection, site management, routine site monitoring and study closure.
  • Collaborate closely with the Chief Medical Officer and Clinical Development teams on clinical operational aspects of studies.
  • Contribute and lead on selection of vendors, CROs and budget negotiations in conjunction with all relevant departments and activities.
  • Work together with relevant teams on budget forecasts & analysis.
  • Assume responsibility for projecting enrolment numbers for clinical studies.
  • Provide strategy and input into the site selection process, working alongside the Chief Medical Officer and relevant members from the Biomedical and wider team(s).
  • Oversee the Informed Consent process and content in partnership with the Chief Medical Officer and Clinical Development, including internal review and approval of the Master Informed Consent.
  • Collaborate with investigative sites on operational aspects of clinical studies.
  • Review clinical monitoring and site monitoring visit reports. Identify and propose strategies for mitigating risks related to enrolment challenges and other clinical operational matters.
  • Manage the data entry and cleaning process at CRO, conduct data reviews, and collaborate on database locking with the Chief Medical Officer, Clinical Development, and relevant data management and statistical teams.
  • Make presentations at Investigator meetings or to Senior Management.
  • Keep the management informed on the clinical operational aspects of our studies through regular dashboards or presentations as needed. Work closely with Quality Assurance (QA) for study site audits or the audit of clinical vendors.
  • Participate in the development of Clinical Operations Standard Operating Procedures (SOPs) as necessary, including transversally to the company.
  • Fulfil any other duties assigned by the company.

Position is based in our Paris or London offices or remotely in the EU.

About you

Required qualifications / experience:

  • Education: Minimum of a Master of Science or equivalent in a biological science field, or a degree in Physician Assistant, Nursing, or Pharmacy.
  • Language: Proficiency in the native language and fluency in English (both spoken and written).
  • Substantial experience in international clinical operations within the drug discovery & development sector as part of a multidisciplinary team, including collaboration with the United States.
  • Experience in managing multi-centre / multi-sites clinical trials in Europe (France, Germany, Switzerland) and the US is required.
  • Experience working in Oncology is essential and experience of working across multiple additional therapeutic areas is preferred.
  • Experience in working with CROs is essential.
  • Previous experience at a Sponsor company (pharmaceutical industry or biotech).
  • Profound knowledge of ICH - GCP is required.

Personal & Interpersonal Skills:

  • Strong organisational and collaborative skills are a must.
  • Demonstrated ability to meet deadlines, exceptional communication and leadership skills, independence, flexibility, proactivity, self-motivation, and a deep passion for Clinical Operations.
  • Ability to thrive in a biotech environment and adapt to a rapidly changing landscape.
  • Proficiency in working within a cross-cultural setting is essential

What we offer

  • Flexible work organization and access to remote work
  • Friendly and informal working environment
  • Opportunity to work with an international team with high technical and scientific backgrounds

Recruitment Process & Security

  • Please complete the form and submit your CV.
  • Owkin is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, gender, sexual orientation, age, color, religion, national origin, protected veteran status or on the basis of disability.
  • Owkin is a great place to work. Unfortunately, being a coveted workplace means we are vulnerable to recruitment phishing scams. We urge all job seekers and candidates to be wary of potential scams. Most of these have individuals posing as representatives of prominent companies, including Owkin, with the aim of obtaining personal, sensitive, or financial information from applicants. These scams prey upon an individual’s desire to obtain a job and can sometimes “feel” like a genuine recruitment process. Some red flags are identified below. Should you encounter a recruitment process that claims to be for Owkin but is not consistent with the below, please do not provide any personal or financial information:
  • Legitimate Owkin recruitment processes include communication with candidates through recognized professional networks, such as LinkedIn.
  • Communication is always through an official Owkin email address (from the @owkin.com domain), over the phone or though our applicant tracking system (Greenhouse).
  • The Owkin talent team do use platforms such as LinkedIn and Job Teaser, however if you have any concern or doubt about this contact, please ask for them to send an email from @Owkin.com.
  • The Owkin talent team will not solicit personal data from candidates during the application phase including, but not limited to, date of birth, social security numbers, or bank account information;
  • Legitimate Owkin interviews may be conducted over the phone, in person, or via an approved enterprise videoconferencing service (Google Meets). They will not occur via Signal, Telegram or Messenger
  • Owkin offers of employment are based on merit and only extended once a candidate has interviewed with members of the talent and hiring team. Offers will be extended both verbally and in written format.

If you think that you have been a victim of fraud,