Director, Clinical Operations

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. 

•    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. 

•    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 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 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.

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

The expected salary range for this position is listed below. 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

Pay Range$200,000—$225,000 USD

Gossamer Bio is committed to complying with federal, state and local law on vaccinations.  Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller.Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment.  Controller’s Privacy team can be contacted at privacy@gossamerbio.com.

 Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes.  Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.

  Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted.  You also have to right to data portability.  In addition, you may lodge a complaint with a supervisory authority.