Senior Clinical Trial Manager (m/f)

Date posted: 10.22.2021
Location: New York

Position Summary

We are looking for a Clinical Trial Manager with strong leadership, organizational, and communication skills to join our highly motivated and dedicated team at Hookipa Pharma; a New York City-based biotechnology company developing novel recombinant viral vector vaccines against cancer and infectious diseases.

Main Responsibilities
  • Responsible for the clinical operations and logistical aspects of assigned Phase I/II trial from start-up to close-out.
  • Lead a global cross-functional Clinical Trial Team (CTT), composed of internal and external team members.
  • Ensure that clinical trial deliverables are met according to timelines to achieve study goals, while meeting Good Clinical Practice (GCP) guidelines.
  • Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans.
  • Contribute to the development of clinical sections of regulatory documents such as: Investigators’ Brochures, IND/NDA submission documents, responses to Health Authorities questions.
  • Management of Contract Research Organizations (CROs) supporting the clinical trial to ensure data integrity and quality.
  • Supervise CRO during study start-up, such as site initiation visit (SIV) meeting planning, case report form development for database, study drug supply design and ordering, and review study site contracts and budgets.
  • Develop site and CRA training materials of the protocol and present these at SIVs and Investigator meetings
  • Develop Protocol and Informed Consent Form documents / amendments in collaboration with cross-functional facilitation. 
  • Provide review and input to the development of study start-up materials such as the clinical trial protocol, protocol amendment(s), Informed Consent Forms, Pharmacy Manual, Monitoring Plan, Laboratory Manual, and site training materials of the protocol.
  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
  • Collaborate with Study Medical Lead and KOLs to determine the medical and scientific needs, and apply them to the protocol and study logistics.
  • Monitor the study budget; review and approve study-related invoices.
  • Review site qualification reports and approve site selections.

Qualifications

  • PhD, MD, PharmD, or MS in life sciences
  • At least 5 years of experience of being a Clinical Trial Manager at a pharmaceutical company, or at a Clinical Research Organization (CRO).
  • Have at least 3 years of experience in early Phase I/II Dose Escalation and Dose Expansion clinical research trial.
  • Have knowledge of GCP, and basic understanding of clinical trial design, regulatory processes, and clinical drug development process.
  • Must have excellent oral and written communication skills, organization and tracking skills.
  • Strong leadership skill, with ability to influence, motivate, and lead.
  • Highly motivated individual, a self-starter with minimum oversight required to accomplish goals.
  • Knowledge of project management skills, capable of managing multiple activities with respect to priorities.
  • Good command of MS-Office (Outlook, Word, Excel, PowerPoint, Project)
  • Fluent in English, both spoken and written

Key Personal Attributes:

  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
  • The ability to work cross-functionally is essential.
  • Excellent communication skills, oral and written, are required.
  • Strong knowledge of clinical research and the drug development process required.
  • Proven ability to work independently and in a team setting is essential.
  • High level of autonomy and motivation.
  • Quality focused and well organized.
  • Ability to handle multiple tasks and to prioritize.
  • Ability to synthesize the information, good presentation skills.
  • Excellent decision-making and problem-solving capabilities.
  • Capability to challenge decision and status quo.
  • Ability to anticipate and timely escalate issues and to define appropriate action plans.

What we offer

  • Strong team with dedicated and passionate employees
  • State of the art infrastructure
  • An excellent working atmosphere
  • Opportunities for personal development
  • Working in a multinational and multicultural environment

We offer a comprehensive package with competitive salary, paid holidays and sick leave, along with a full range of medical, dental/vision insurance and 401(K) plan. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

Contact:

If you (m/f) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: talent@hookipapharma.com

For more information on HOOKIPA please visit www.hookipapharma.com

Apply Now!

Contact
Gwenaelle Kerforn Executive Director Human Resources