Clinical Development | San Francisco, Ca | Full Time
Overview of the Role
The successful clinical scientist candidate will play a pivotal role in ensuring alignment between clinical strategy and clinical study protocols, operational structure, formalized processes, and tactical execution. This individual will enhance the execution of the vision, mission, and values of the Parker Institute by keeping a watchful eye on the moving parts and the dynamic environment while ensuring teams and programs are moving forward within scope, schedule, and budget.
This individual will work closely with scientists at member institutions as well as external stakeholders, vendors, and PICI colleagues to evaluate and plan collaborative clinical trials across the consortium. Under the oversight of the Medical Director, the Clinical Scientist is responsible for directing the design and execution of clinical studies in order to successfully move collaborative programs through the clinical research process in a timely manner, in adherence with GCP, appropriate SOPs, and government regulations. S/he will collaborate with the clinical team to develop clinical plans and protocols, investigational brochures, clinical study reports and documents that support development and execution of clinical studies.
The role provides strong leadership, strategy, oversight for execution of novel Immuno-Oncology (I-O) clinical/translational studies. S/he will be integrally involved in ensuring quality data collection, data cleaning and data interpretation. The individual will build and foster relationships with clinical investigators and sites. This individual must work well with a cross functional team, have good attention to detail and be able to work on multiple complex study designs. A background in immunology and oncology is highly desired. This individual should be knowledgeable in GCP practices.
The Clinical Scientist will be a key contributor in building an integrated development plan and will provide support to new development activities, as well as clinical guidance and assessment of future opportunities to advance the science and address unmet needs in oncology immunotherapy clinical development.
Reporting Structure and Team
The Clinical Scientist reports to the Medical Director and is a key member of the Clinical Development team.
Essential Job Functions
- Under the direction and oversight of the VP, Clinical Research and Development, design, oversee and/or execute, as needed and as appropriate, clinical deliverables and clinical/translational strategy for collaborative studies and programs
- Support the VP of Clinical Research and Development and the Medical Director in the evaluation of new project opportunities presented by member researchers across the consortium and external partners
- Development assessments of clinical programs to support therapeutic advancements using innovative approaches and new therapeutic initiatives
- Clinical support on implementation teams, providing subject matter expertise, clinical science support and functional representation
- Develop and lead the clinical science project team. As appropriate, coaches and guides clinical development scientists, and in such instances, is responsible for hiring, training, developing and retaining talent on staff. Provide leadership, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities
- Key clinical deliverables include document development: Study concepts/ synopses, clinical protocols, investigator’s drug brochures (IB), clinical study reports (CSR), ICF, and other regulatory documents
- Review, analyze, interpret, and present both clinical and translational data both internally and externally
- Collaborate with translational informatics and biometrics on clinical and correlative data analyses for CSR compilation, output generation for presentations and manuscripts
- In compliance with the research strategy, and in collaboration with PICI project teams, expand and oversee investigator agreements and contracts. Establish and lead collaborations with external partners
- Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications. Support publication strategy execution including collaboration with investigators, KOLs, medical affairs and other internal/external stakeholders. Present at investigator meetings and scientific conferences
- Ensure the appropriate reporting of the events to the Clinical Development Department and applicable Regulatory Authorities throughout the life of the trial
- Act as the liaison between the Safety department and all other internal departments as well as to external customers such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated with the trial
- May interact with the FDA, corporate partners and cross-functionally across PICI
- Responsible for understanding and implementing the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.
- May be responsible for oversight of study and overall timelines for key deliverables
Knowledge, Skills, and Experience
- Undergraduate degree required with specialization in biological sciences, immunology, chemistry, chemical engineering, biomedical engineering or related is required. An advanced degree is a plus.
- Clinical Research Certificate is desirable
- Expertise in oncology or immunotherapy required, with drug development experience highly desirable
- Strong background in clinical trial design and execution in an academic or industry setting. The ideal candidate will have at least 10 years experience at a leading pharmaceutical, CRO or biotechnology company or academic center.
- Passion for advancing patient care and working in a collaborative team environment
- Committed to the values of integrity, collaboration, accountability, transparency and drive
- The skills required for success in the job include scientific and analytic ability
- Ability to think strategically and tactically with an interest in applied clinical research
- Ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize
- Demonstrated ability to evaluate, interpret and present complex scientific data
- Excellent oral and written communication skills.