Global Trial Leader

Location: 

Philadelphia Area, Cherry Hill, NJ, US

 

 

About Idorsia Pharmaceuticals Ltd

 

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

 

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

 

Headquartered in Switzerland, Idorsia is specialized in the discovery and development of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

 

Idorsia has US operations based in Cherry Hill, New Jersey with 20 professionals supporting the clinical development of our innovative pipeline in North America.

 

 

Job Responsibilities

 

  • Oversees a clinical trial to ensure early input, with regards to timelines and cost, into planned Phase 2/3 trials.
  • Creates and monitors project plans, including key milestones and timelines, consistent with the trial strategy.
  • Creates a forecast for resources on clinical trials, and monitors the workload of on-going projects, escalating any substantial variations.
  • Consults with necessary Clinical Development department heads to ensure proper resource planning and outsourcing strategy for the planned clinical trials.
  • Leads and provides direction to the clinical trial team (CTT) to ensure all trial output from protocol development to final clinical trial report are delivered on time, within budget and with highest achievable quality.
  • Develops, updates, and ensures adherence to approved global trial budget, including grant management and Investigator fees.
  • Coordinates the development of trial-related core documents, such as the protocol, site guidelines, data management plan, statistical analysis plan, and clinical trial report.
  • Contributes to trial investigational and non-investigational medical product (IMP and NIMP) planning and track supply usage, escalating any substantial variations.
  • In collaboration with program and trial teams, develops high-level country and site strategy plan for clinical trials, and validate final choices to ensure optimal trial conduct.
  • Identifies gaps/overlaps in processes and contributes to improvements.
  • Chairs CTT meetings and ensures timely follow up of agreed upon actions.
  • Leads Investigator Meetings.
  • Provides regular trial status updates (including critical issues and key performance indicators) and resolves issues at the CTT level in a proactive and timely fashion.
  • Escalates unresolved issues as appropriate.
  • Provides input for surveys and audit reports.
  • Ensures implementation and supervises respective corrective and preventive actions on trial level (CAPAs).

 

Candidate’s Requirements

 

  • Requires a Bachelor's degree (Masters or Doctorate degree a plus) in life sciences or related field.
  • At least 4 years of relevant experience in clinical research in a pharmaceutical and/or Contract Research Organization (CRO) environment, with a good scientific and operational understanding of Phase 2/3 clinical trials.
  • Experience in all aspects of clinical trial planning and start-up (including budget & resource planning) and in executing a wide range of clinical trial activities, from set-up through to final clinical trial report.
  • Demonstrated expertise in clinical development and project management (including risk management and contingency planning).
  • Excellent understanding of the roles and responsibilities of all relevant functions involved in a clinical trial and (e.g. Biostatistics, Data Management, Regulatory, Drug Safety, external service providers, etc.).
  • Experience working in global cross-functional (matrix) and multicultural teams.
  • Good understanding of clinical trial budget/resource forecasting and management.
  • Able to develop an understanding of the scientific background of trial protocols.
  • Well-versed in International Council for Harmonization - Good Clinical Practice (ICH-GCP) guidelines and other relevant clinical trial regulations.
  • Fluent in English; fluency in other languages is advantageous.
  • Ability and willingness to travel internationally.
  • Experience in managing complex clinical trials
  • Open to improvement and new ideas, contributes with new ideas.
  • Ability to share expertise and experience with team members and across teams.
  • Good communication, presentation, negotiation, and problem solving skills focusing on key priorities with ability to effectively persuade, motivate and influence others.
  • Analytical and results driven with a keen understanding and support of the business needs.
  • Able to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful manner combined with good time management skills.
  • Excellent team working skills within international and cross-functional environments, ability to foster a team environment.
  • Thinks beyond the confines of own function; considers interfaces, understands need for and actively fosters cross-functional cooperation.
  • Good leadership skills, able to guide teams and to influence and motivate people; this includes setting priorities, and tracking of timely delivery and quality.

 

Physical Requirements

 

  • Talk, hear, and use fingers and hands to perform repetitive motions (computer work).
  • Carry up to 20 pounds of weight occasionally.
  • Close visual acuity to perform activities such as preparing and analyzing data and figures.

 

What Idorsia offers

 

  • Potential to telecommute 1-2 days a week (after 90 day probation period) with supervisor approval.
  • Exciting opportunities for development and professional growth within our dynamic organization.
  • A collaborative and solution oriented enviroment where you can make a difference.
  • An innovative and open culture in a truly multicultural environment.
  • A competitive salary and generous benefits.

 

Work  Location: Philadelphia Area - Cherry Hill

Country: USA

Business Area: Global Clinical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1057

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.

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