Clinical Lead, Early Development Oncology

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
Your role as Clinical and Project Leader, early development (PL) is at core of Owkin’s ambition to become a full-stack AI Biotech. In this strategic role you will develop and deliver global strategies and plans for early (Phase I/II) clinical program(s). Together with a supporting highly-collaborative matrixed cross functional Core Team you will be accountable for the project strategy, as well as the vision and overall success of the project. The PL role is a strong background in pharmaceutical development in oncology, exceptional leadership skills, and a strategic mindset.
This role reports to Owkin Head of Oncology, under the Chief Medical Officer, and is embedded into the Biomedical team.
Ability to work within a cross functional, and multicultural team, including with external business partners are key attributes for this position.
The ideal candidate is an experienced early-phase oncology clinical trialist, MD or MD/PhD preferred, PharmD possible, with a proven track record of delivering FIH dose escalation/expansion studies in a cross-functionally matrixed development team environment and a passion for getting new medicines to patients.
In Particular, You Will

• Collaboratively author and be accountable for the Clinical Protocol.
• Collaboratively author and be accountable for the Investigator’s Brochure
• Chair the Safety Review Committee for clinical studies.
• Work closely with the Translational Lead to ensure successful implementation of the biomarker strategy
• Propose short-term and long-term objectives spanning from Phase I preparation until Phase II.
• Together with the Core Team members, prepare plans for assigned project(s) and ensure alignment of project goals with Owkin strategic objectives.
• Propose a global development plan, optimizing quality, costs and timelines, delivering upon increased project valorization potential.
• Actively drive the project for completion of milestones, while addressing, minimizing and managing risks, promptly identify and report deviations from the plan requiring appropriate feedback from management.
• Lead the preparation and execution of Phase I/II development plans of the asset at the core team and sub team level.
• Lead the Core Team, ensuring alignment to Okwin objectives.
• Effectively analyze all relevant project data and information to come to conclusions and solutions and is problem solving oriented.
• Communicates effectively with others in figuring out solutions to complex problems. Understands functional impact of different options.
• Inform management about asset progress and present high-level updates at strategic and governance meetings to enable corporate decision-making.
• Work closely with project partners including external experts, scientific societies, KOLs, service providers.
• Contribute actively to regulatory documents as required.
• Prepare accurate updates, progress reports and presentations for team members and management to ensure timely information flow.
• Contribute to strategic planning across R&D to integrate programs and research initiatives at the portfolio level.
• Ensure that all activities related to the asset comply with regulatory requirements and industry standards.
  

Position is based in our Paris or London offices or remotely.
About You
Required qualifications / experience:

• MD, MD/PhD or PharmD, PharmD/PhD
• Substantial level of years of experience in early stage clinical development in pharma or biotech, in Oncology/ImmunoOncology
• Experience of global development projects (small molecules preferentially) & understanding of cross-functional interdependencies (e.g., clinical, CMC, commercial, regulatory…) and track record of effectively work in a matrix environment
• Demonstrated ability to identify critical program risks and opportunities and develop mitigation and maximization plans
• Very good understanding of regulatory, CMC and clinical trial operations.
• Strong organizational and project management skills.
• Experience of drug development with partners and outsourcing
• Strategic thinker and capacity to federate a team towards common objectives.
• Excellent English oral, written and presentation skills
• Sense of urgency
• Ability to work in a multicultural environment
• Strong communication and interpersonal skills
  

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,

• Check the identity of the talent team on LinkedIn.
• Check the existence of the position on our website https://owkin.com/hiring
• Notify Owkin's recruitment unit at this address hiring@owkin.com
• contact the following authorities:
• [FR] https://www.internet-signalement.gouv.fr/
• [UK] https://www.actionfraud.police.uk/reporting-fraud-and-cyber-crime
• [US] https://reportfraud.ftc.gov/