What are the responsibilities and job description for the Director, Clinical Operations position at Exokeryx, Inc.?

JOB SUMMARY

If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.

The Director, Clinical Operations is responsible for operational oversight, planning, implementation, and conduct of assigned clinical trials outsourced to Clinical Research Organizations (CROs) and in compliance with applicable clinical and regulatory standards to ensure successful clinical trial implementation and execution.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Oversee the execution of phase 1-3 clinical trials in an out-sourced model from study start-up to final clinical study report; anticipate problems and propose risk mitigation plans to ensure successful and timely completion of the trials.
Provide oversight to the Clinical Operations Manager function in the day-to-day management of trials.
Actively and effectively communicates within Clinical Operations and across functional areas regarding the developments, progress, activities, and results for assigned responsibilities.
Oversee CRO study conduct to monitor adherence to regulatory requirements, GCP per relevant contracts.
Oversee CRO generation of applicable clinical documents, study-related manuals, and procedures.
Provide oversight of Trial Master Files for assigned clinical programs.
Provide oversight and input to additional study-related external vendors, including execution of work and tracking of milestones and deliverables.
Independently identifies, escalates, and resolves cross-functional and vendor issues as necessary.
Drives the Request for Proposals (RFP) process and in the selection of CROs and other applicable vendors.
Provide clinical input to protocol and other documents as required.
Prepares and delivers status updates to senior and executive management as needed. Supports Clinical Operations Managers by reviewing study status reports and updates, providing guidance as needed.
Forecast trial resource needs (external costs); accountable for the management and tracking of trial and program level clinical operations budget.
Collaborate across a variety of functional groups including Clinical Development, Biostatistics and Data Management, Regulatory, Drug Supply, Project Management, Contracts, and Finance to plan and execute responsibilities.
Oversees, manages, and communicates overall clinical operations plan for investigational trials including timelines, internal and external resources / costs, and critical deliverables.
Represent Clinical Operations and the Product Clinical Development Team with responsibility to align and inform the Clinical Operations Leadership of CDT strategies, activities, and shifting priorities of the program.
Assist with Standard Operating Procedure (SOP) development and implementation.
Provide active coaching and mentoring of junior clinical operations team members.

JOB QUALIFICATIONS

Education, Certifications, Experience

Bachelor’s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study.

10 years’ experience in prior positions of increasing responsibility in clinical operations.

Experience with clinical development required.

Experience in rare disease or PAH highly desirable.

Experience independently managing multiple leading global clinical trials and oversight of full-service CRO and / or third-party vendors is required.

Knowledge, Skills and Abilities

Knowledge of FDA and / or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.

Working knowledge and experience with Word, PowerPoint, SharePoint, and Excel.

Excellent interpersonal skills and demonstrated ability to lead is required.

Excellent verbal, written, interpersonal and presentation skills are required.

Creative problem solver with the ability to address issues quickly and independently, balanced with judgement to escalate issues as needed.

Strong attention to detail and dedication to accurate and high-quality work.

Focus on results, highly collaborative cross-functionally, and proactive.

Builds strategic relationships with business partners, external vendors, and alliance partners.

SPECIAL WORKING CONDITIONS

Office environment / Domestic and International travel will be necessary.

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state, and local laws governing nondiscrimination in employment.

The expected salary range for this position is $200,000 to $225,000 . Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below :

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching, long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https : / / www.gossamerbio.com / work-at-gossamerbio /

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Salary : $200,000 - $225,000

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