Regional Study Director, Latam

Crinetics is a pharmaceutical company headquartered in San Diego, California, with a growing presence in Latin America, including an office in Brazil. We are developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. This is an exciting time to join Crinetics as we expand our operations in Latin America and shape our organization into the world's premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

Please note, the candidate for this role will need to be located in Brazil.

The Regional Study Director, LATAM is responsible for managing the execution of clinical studies and data collection within the LATAM region. The incumbent will serve as a regional clinical study lead who oversees the review, monitoring, and adherence to clinical protocols, as well as managing and building relationships with clinical sites in LATAM. The Regional Study Director, LATAM may oversee other regional study leads within the region to facilitate a streamlined and quality study execution. This role will also work internally and externally with members of the cross-functional study team.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide oversight of clinical research studies for LATAM.
• Manage and build relationships with clinical research sites in LATAM.
• May oversee the work of other regional study leads within LATAM.
• Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
• Oversight of all regional vendors and activities including CROs.
• Oversee regional start up activities including site selection, enrollment projections and activities driving site activation.
• Develop region specific the subject recruitment/retention strategy and related initiatives.
• Oversight of regional TMF ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate site insurance, and/or supervision of team members performing these activities.
• Development of training materials for study team, investigational sites, and vendors.
• Proactive management of information sharing with key stakeholders using standardized reports and other mechanisms.
• Assure clinical studies are compliant with GDPR, ICH/GCP and other regulations as appropriate.
• Outline regional activation hurdles for team.
• Participate in RFP development and prepare bid templates to facilitate selection of the CROs/vendors, and/or collaboration/supervision with team members performing these activities.
• Collaborate with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed.
• Acts as liaison with Regulatory Affairs to assure adherence to GDPR, GCPs;
  maintenance of SOPs;
  and assure site and CRO/vendor audits are completed.
• Perform regional risk management and implement mitigations.
• Identify potential study issues and recommend and implement solutions or corrective actions as needed.
• Create realistic plans that clearly define goals, milestones, responsibilities, and results.
• Maintain focus on strategic objectives while accomplishing operational goals.
• Make timely, data-driven decisions.
• Manage daily activities, assign tasks, goals, and development of direct reports.
• Other duties as assigned.

Required Education and Experience:

• Bachelor's degree required, preferably in scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered.
• 12 years of prior clinical operations experience preferably with CRO/small biotech experience and approximately 8 years of experience in a supervisory role.
• Must be able to travel 25-50% of time, may be higher in accordance with project requirements.
• Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IXRS and EDC systems.
• Excellent understanding of drug development process.
• Experience in clinical trial supply management.
• Able to make appropriate decisions to move the project(s) forward.
• Effective verbal and written communication skills.
• Data flow from sites to data processing, review, and resolution.
• Analysis and report generation.
• Knowledge of local regulatory requirements.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
• Study initiation procedures.
• Ability to exercise judgment and determine appropriate action

Travel:

You may be required to travel for up to 25-50% of your time.