Global Study Director
3 weeks ago
We are seeking a highly experienced Global Study Director to lead our CAR-T cell therapy studies. The successful candidate will have a strong background in clinical research, with a focus on CAR-T cell therapy and immunology indications.
Key Responsibilities- Lead and coordinate cross-functional study teams to ensure timely and successful completion of CAR-T cell therapy studies.
- Contribute to vendor/ESP selection activities and lead operational oversight to ensure control over vendor identification and selection.
- Assist the (Sr)GPD with operational planning for upcoming clinical studies to establish required resources for study conduct.
- Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams.
- Lead and facilitate communication across functions and provide guidance and support to study team members as needed.
- Provide operational expertise into and hold accountability for development of essential study level documents.
- Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget.
- Develop and maintain relevant study plans, including required input into study level quality and risk management planning.
- Oversee study level performance against agreed upon plans, milestones, and KPIs, and communicate any risks to timelines and/or quality to CPT.
- Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones.
- University degree (or equivalent) in medical or biological sciences or a discipline associated with clinical research.
- Proven project management experience and training.
- At least 7 years of clinical trial experience.
- At least 3 years of experience in global study leadership and team leadership.
- Experience in CAR-T studies is required.
- Experience in Respiratory or Immunology indications preferred but not required.
- Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery.
- Thorough understanding of the cross-functional clinical trial process.
- Strong strategic and critical thinking abilities.
- Proven skillset and abilities in complex problem solving and decision-making.
- Strong abilities in establishing and maintaining effective working relationships with senior stakeholders, along with strong conflict management skills.
- Demonstrated abilities in mentoring.
- Excellent communication and interpersonal skills.
- Ability to manage multiple competing priorities.
Experience in external provider oversight and management is also required.
What We OfferWe offer a competitive salary, a range of additional benefits, and a diverse culture that rewards high performance and nurtures talent.
Our benefits include various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global Employee Assistance Programme.
We are an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.
If you need a reasonable accommodation for any part of the application process, please let us know or submit a request.
We encourage you to apply regardless of whether you meet all of the requirements.
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