Summary:
The Global Clinical Scientist, ILD-PH Clinical Development position will have a key role in supporting the clinical development of seralutinib for the treatment of pulmonary hypertension associated with interstitial lung disease (ILD-PH). This includes contributing and having day-to-day responsibilities related to the conduct of the Phase 3 global clinical trial. This role will work in conjunction with Clinical Development, Clinical Operations, Medical Affairs, and CRO study teams. The Global Clinical Scientist will develop and support review of various study related documents, regularly review and provide updates on clinical study information, and identify areas for improved efficiency.
The Global Clinical Scientist will also review and validate clinical study reports (CSRs)and along with team members, is responsible for ensuring the clinical data as part of the Phase 3 program is of the highest quality.
Essential Duties and Responsibilities
- Provide day-to-day oversight on the global Phase 3 study in ILD-PH.
- Under Direction of the Program Clinical Development Lead, provide general clinical and scientific supportin all aspects of Clinical Development, including the design, preparation, general conduct, analyses, and reporting of the clinical studies.
- Review and input on clinical and regulatory documents e.g. clinical study reports.
- Participate in authorship of clinical/regulatory documents including clinical development plans, investigator brochures, safety risk management plans, and regulatory briefing packages.
- Review data listings to ensure the data is of the highest quality.
- Cultivate strong relationships and robust communication among the clinical study/project team and the development organization.
- Participate in weekly meetings with clinical operations, CRO, others, as a Clinical Development representative.
- Liaise with other Gossamer Bio functional areas as needed to support the clinical study.
- Provide support for the GB002 clinical development plan for ILD-PH incorporating pre-clinical, clinical, regulatory, operational, biometric, CMC, and commercial strategies in accordance with corporate objectives. Provide feedback on therapeutic area guideline trends to identify and/or inform potential protocol amendments, accrual barriers, patient/study subject identification.
- Identify potential issues and lead contingency planning efforts; lead team problem solving efforts and applies decision-making tools and techniques, driving teams to make effective and efficient decisions.
- Contributes to the analysis and summary of the clinical findings from studies to support decisions regarding safety and efficacy and may function as the primary author as the subject matter expert.
- Conduct site visits with investigators and study staff (when appropriate) to foster relationships, ensure study conduct is of high quality and consistent with expectations established at study initiation.
JOB QUALIFICATIONS
- Advanced Degree in Life Sciences (PhD, Pharm D, or MD).
- 2-5+ years of experience in clinical science, clinical research, or equivalent.
- Broad knowledge of the drug development process including early and late phase development.
- Experience in data analysis and utilizing Excel and power point.
- Experience in writing and editing scientific and regulatory documents including clinical protocols and regulatory documents.
- Advanced analytical and influencing skills and proficient at data interpretation.
- Experience in conducting literature searches and synthesizing the information.
- Expert understanding of global clinical study design and drug development processes.
- Strong understanding of GCP and ICH Guidelines.
- Excellent interpersonal skills; able to work independently and collaboratively; exercise sound judgment, escalate issues when necessary, and motivate team members.
- Experience in presenting at both internal and external meetings.
- Office Environment based in San Diego, CA or Remote.
- Up to 20 % travel required as needed to support clinical study/program.
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 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
https://www.gossamerbio.com/work-at-gossamerbio/
Pay Range$160,000—$205,000 USD
California Consumer Privacy Act (CCPA) Notice for California Residents:
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.
