Study Director

Location
San Diego, CA
Posted
Apr 29, 2022
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Certis is a precision oncology and translational science company. We provide clinically relevant, predictive data that empowers cancer patients, informs treatment decisions and we also provide pre-clinical translational drug discovery services to Pharma and biotech to reduces drug development risk. At Certis, we don’t challenge market leaders or competitors. We challenge resistance to change—a mindset willing to accept the status quo or “good enough.” We’re gaining momentum, and we’re looking for like-minded A-team players to join our team.

Certis values a collaborative and creative matrix where each team member is encouraged to contribute to our processes, decisions, planning and company culture. We are a licensed California Clinical Laboratory with CLIA certification for high-complexity testing, and located in Sorrento Valley, the heart of San Diego’s life sciences industry.

POSITION DESCRIPTION

The Study Director is responsible for coordinating and documenting the details of Pharma and/or Patient Studies with all affected stakeholders, and for ensuring that the Laboratory executes each study in accord with the prescribed protocol for that Study. In the case of Pharma studies, the Study Director also acts as the internal advocate for the customer, and as the spokesperson for the Laboratory on behalf of the Study.

The Study Director collaborates with the In Vivo, In Vitro, Operations, R&D, Business Development, Customer and Accounting teams, as necessary to (a) define and document the study protocol, (b) identify required materials, (c) initiate the acquisition of required materials, and (d) launch, monitor and communicate performance/progress of the study to the Customer representatives.

The Study Director is also responsible for preparing the Final Study report for both Patients and Pharma, for review and approval by the Lab Director (Patients) or the VP Operations (Pharma) or his/her delegate.

Key attributes for success in this role are a thorough understanding of Pharmacology pre-clinical studies, attention to detail, strong project management skills, and a crisp, confident communication style.

JOB RESPONSIBILITIES

Process Development and Improvement

  • Design, develop and implement a scalable set of policies, processes and systems to create an institutional best in class approach to both operations and the customer experience.

Study Planning

  • Define, with the Customer and Laboratory staff, the nature and methodology of the Study design (Protocol), to include definition and documentation of the Study Protocol for Customer signature.
  • Identify required materials to procure for each study: mice, study-specific compounds or consumables, etc.
  • Partner with In Vitro and In Vivo teammates to schedule lab staff activities within the and in accord with the Protocol.

Study Progress and Final Reporting

  • Influence/Monitor Lab execution in accord with the Protocol, and provide periodic progress reporting to the Customer.
  • Coordinate the timing of Invoicable events with Certis Accounting
  • Escalate unforeseen anomalies to the VP Operations and/or the CFO for guidance and advisory support
  • Develop DRAFT Patient and Pharma Study reports for review and approval by the Lab Director (Patient Studies) or the VP Operations (Pharma Studies)

EDUCATION AND EXPERIENCE

  • Bachelors and/or Master’s in Science in relevant scientific field, with preference towards Molecular Biology, and/or Oncology. PhD desirable.
  • At least 4 years industry operations experience in In Vivo, In Vitro, Histology and/or Flow Cytometry in an Oncology field. CRO experience highly desirable. Experience as a Study Director is highly desirable.
  • Strong writing, editing and verbal communication skills.
  • The ability to communicate, constructively, scientific information to a variety of audiences
  • Proficiency in MS Office Suite (Word, Excel, PowerPoint)
  • Positive attitude with great interpersonal and project management skills, and attention to detail.