© 2018 by Trefoil Therapeutics, Inc.

Open Position:  Director, Clinical Operations

To apply send your curriculum vitae to:  careers@trefoiltherapeutics.com

Department:            Research and Development

Location:                  San Diego, CA

Classification:          Exempt

 

GENERAL OVERVIEW OF POSITION:

 

This position reports to the Chief Executive Officer of the corporation.  The position is responsible for the clinical research function as well as ensuring the highest quality of clinical science within the corporation.  The Director, Clinical Operations guides and executes all aspects of clinical trial operations including protocol development, CRO and site selection and management, IRB management, medical monitoring, data analysis and report generation.  The position is a key member of the development team and participates broadly in development activities, including regulatory, bioanalytical, key opinion leader management, research plans and providing data to the board of directors.

 

KEY ATTRIBUTES AND COMPETENCIES:

 

  • Excellent technical and scientific problem-solving skills to ensure timelines, budgets, and milestones are met or exceeded

  • Able to motivate technical staff with diverse backgrounds and levels of expertise as well as CROs and CDMOs to high levels of productivity and enthusiasm

  • Foster originality in the company’s approaches to solving research-based problems

  • A results-oriented approach that conveys a sense of urgency and drive for closure with the ability to execute and prioritize multiple, competing tasks and demands and to recognize and execute critical details

  • Dedication and passion for developing new products and getting them to patients and a sense of urgency for doing so

  • Excellent communication skills with the ability to communicate effectively and credibly with all stakeholders

  • Able to communicate and negotiate with regulators, CROs, IRBs, physicians and sites to ensure high quality and timely clinical program execution

MAJOR DUTIES OF POSITION:

 

  • Work with senior management to define clinical and regulatory strategies

  • Develop protocols and associated documentation with CROs and consultants, including maintaining TMF, statistical analysis plans, safety reports, integrated final study reports and operational plans

  • Develop and manage study timelines

  • Identify, contract with, and manage CROs and consultants; maintains frequent and meaningful contact to assess performance and provide guidance

  • Ensure timelines, milestones and budgets are met

  • Integrate the activities of all functions associated with clinical trials

  • Leads ongoing review of procedures, processes and data to ensure GCP; oversees site and vendor audits

  • Identify and provide solutions to trial risks and issues

  • Provides or arranges training to CROs and sites as needed

KNOWLEDGE AND SKILL REQUIREMENTS:

 

  • BS, BSN/MSN or equivalent

  • Minimum of 5 years experience in clinical operations in a biotech/pharmaceutical environment including phase I and II trials

  • Thorough knowledge of FDA, ICH and GCP guidelines related to clinical trials

  • Experience preparing regulatory submissions and interacting with FDA and other regulators

  • Experience in all phases of clinical trial operations from protocol development to final reports and including monitoring, training and site interactions

  • Able to integrate preclinical and clinical data into clinical strategy, protocol design, and data interpretations

  • Experience working with CROs and consultants for the execution of trials

  • Experience operating multicenter trials, including private and academic sites

  • Ophthalmic trial experience preferred but not required

PHYSICAL DEMANDS:

 

To perform this job successfully, an individual must be able to carry out each essential duty satisfactorily.  They must be able to travel domestically and internationally.  The requirements listed are representative of the level of knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

 

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

TREFOIL THERAPEUTICS IS AN EQUAL OPPORTUNITY EMPLOYER