Do you have expertise in Oncology, and experience with cell therapy? As a Global Study Director, Cell Therapy, Clinical Operations, you will deliver a single or several smaller Cell Therapy development programs.

Join us to apply your expertise to affect the lives of patients living with cancer, follow the science, and turn ideas into life-changing medicines. You will report to the Executive Director, Solid Tumor Cell Therapy Clinical Operations.

You Will:

Clinical Operations delivery of a single or several smaller development programs or leading multiple studies or single sophisticated/novel studies. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility and autonomy is required. 

May also provide authoritative input to other non-drug programs and improvement projects. 

Provides authoritative clinical operational input into project or study level documents, for example, clinical development plan, clinical study protocol, clinical study report, and may own the delivery of study documents 

May lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions 

Owns the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards 

Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate 

Ensure sponsor oversight throughout the life of the study 

Develops and leads effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and advance issues to partners as appropriate 

Responsible for planning and leading issue customer concern and resolution 

Provide input to forecasting and management of study/program delivery costs, resource and timelines 

Accountable for the quality of study/program planning information into relevant planning systems 

Mentors and supports the development of individuals within the organization 

Contributes to operational interactions with external entities, including regulatory agencies, preferred partners/suppliers, and external collaborators 

Responsible for oversight of CROs and other clinically outsourced third-party vendors for outsourced studies and programs 

Responsible for study-level reporting of progress, risks, and issues 

Lead the study delivery-related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance 

Provide procurement clear specifications for study or program-specific outsourcing 

Review and operational approval of study or program-specific contracts or work orders 
 

You Have:

Bachelor’s degree in related subject area, preferably in medical or biological science. 

10+ years of drug development experience from within the pharmaceutical or biotech industries 
 

Required Skills:

Clinical Operations and Cell Therapy or Gene Therapy experience 

Extensive and shown experience in driving operational delivery to timelines, cost and quality 

Shown experience leading delivery through internal and external organizations. 

Excellent knowledge of ICH-GCP principles 

Experience and strength in working and leading in matrix teams 

Strong collaborative communications skills including the ability to engage with a diverse client base and lead through conflict 

Proven track record in problem solving and issues management that is solution focused 

Ability to lead strategic and/or operational management of individual clinical trials 

Experience in providing clear requirements for external contracts 

Experience in selection of external providers and development/review of contracts 

Confirmed oversight of external providers 
 

Desirable Skills:

Advanced degree e.g. PhD, MSc, MPhil 

Program management qualification (e.g. MBA, PRINCE2, PMP) within the context of Clinical Drug Development 

Experience in a variety of academic/CRO/Sponsor organizations and countries 

Experience of early-phase clinical delivery 
 

Our Benefits:

Benefits offered include:

• A qualified retirement program [401(k) plan]

• Paid vacation, holidays, and paid leaves

• Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 

The annual base salary for this position ranges from $162,566 to $243,849. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

#celltherapy #LI-Onsite

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.