Global Clinical Scientist / Director, Clinical Development

SUMMARY:

The Global Clinical Scientist / Director, Clinical Development will have a key role in supporting the clinical development of seralutinib for the treatment of pulmonary arterial hypertension (PAH). This includes contributing and having day-to-day responsibilities related to the conduct of the Phase 3 PROSERA study in PAH. This role will work in conjunction with the Clinical Development Lead, Study Teams, CRO, Clinical Operations, and Medical Affairs teams to resolve site challenges, support recruitment efforts, answer protocol related questions during trial execution, and to assist in the ensuring that 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 PAH partnered with the Clinical Operations Co-lead.
• Under Direction of the Program Clinical Development Lead, provide general clinical and scientific support in all aspects of the PAH Clinical Development program, 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, PIPs 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 and PAH program.
• Provide support for the GB002 clinical development plan for PAH incorporating pre-clinical, clinical, regulatory, operational, biometric, CMC, and commercial strategies in accordance with corporate objectives.
• Provide feedback on specific sites and regions, and therapeutic area guideline trends to identify and/or inform potential protocol amendments, accrual barriers, patient/study subject identification.
• Leverage relationships to ensure interest and commitment from clinical investigators for study enrollment and open communication regarding feedback to Gossamer.
• Identifies potential issues and leads contingency planning efforts; leads 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 i.e. study documents, clinical study reports, regulatory documents, or publications for some documents and sections, 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.
• Support clinical development of seralutinib for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).

JOB QUALIFICATIONS

• Advanced Degree in Life Sciences (PhD, Pharm D, or MS)
• 3-5+ years of experience in clinical science, clinical research, or equivalent.
• Therapeutic expertise in pulmonary arterial hypertension (PAH), pulmonary hypertension in interstitial lung disease (PH-ILD), idiopathic pulmonary fibrosis (IPF), or rare diseases.
• 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 leading Phase 2 and Phase3 studies and study teams
• 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 30 % 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 $183,000 to $230,000. 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/