Clinical Development | San Francisco, Ca | Full Time
Bench International has been retained exclusively by the Parker Institute for Cancer Immunotherapy to identify qualified candidates for consideration for the role of Medical Director. Reporting to the Vice President, Clinical Development, this position will be based in San Francisco, California.
In April 2016, the Parker Foundation announced a $250 million grant to establish the Parker Institute for Cancer Immunotherapy (“Parker Institute” or “PICI”). For decades, entrenched infrastructure barriers have slowed progress in the fight against cancer and the development of potent immunotherapies. The Parker Institute breaks down these barriers. The result is a groundbreaking new research and intellectual property model that builds collaboration between researchers, nonprofits and industry all working together to get treatments to patients faster. The Parker Institute builds upon the foundation’s leadership in funding and promoting research and reflects 10 years of support for immunotherapy research by Sean Parker, PICI’s Founder and Chairman, including his backing of the Stand Up to Cancer and Cancer Research Institute Immunotherapy Dream Team. In 2013 Mr. Parker was awarded the Oliver R. Grace Award for Distinguished Service in Advancing Cancer Research by the Cancer Research Institute.
The Parker Institute’s flexible model enables PICI to work with researchers in a variety of ways so they can empower them to do their best science. PICI started the program by providing institutional support to six academic centers, which are pioneers in the cancer immunotherapy space, including Memorial Sloan Kettering Cancer Center; Stanford Medicine; the University of California, Los Angeles; the University of California, San Francisco; the University of Pennsylvania and The University of Texas MD Anderson Cancer Center. More recently, PICI initiated new programmatic support for outstanding investigators, including a talented group of researchers at Dana-Farber Cancer Institute, Robert Schreiber, Ph.D. of Washington University School of Medicine in St. Louis, Nina Bhardwaj, M.D., Ph.D. of the Icahn School of Medicine at Mount Sinai and Philip Greenberg, M.D. of the Fred Hutchinson Cancer Research Center. PICI believes that this multifaceted approach to bring the best and brightest minds in basic and translational research will accelerate the development of cancer immunotherapies with the greatest chance of impact on patients.
- Funding: The Parker Institute created a unique funding approach to overcome many of the obstacles that currently prevent research breakthroughs. Traditional scientific grants fund individual research projects without connection to a broader scientific strategy. They deliver small amounts of money and drive only incremental advances. The Parker Institute takes a new approach: PICI convenes the field’s leading researchers to develop a scientific roadmap, then provides major funding for high-risk, high-reward collaborative research projects to achieve key goals. Failure is an option if it leads to new insights and new avenues for investigation.
- Intellectual Property: As regards intellectual property, when one researcher makes a discovery or collects data in a trial, PICI’s entire network of researchers gains access to and can work to advance the discovery. Sharing discoveries is a key tenet of PICI’s collaborative model and leverages the collective power of our researchers to gain insights quicker and get treatments to patients faster. The Parker Institute does not own the intellectual property generated by their researchers. Each of PICI’s member academic institutions owns the intellectual property for their respective inventions. The Parker Institute does, however, manage the intellectual property collaboratively with representatives from each academic institution from discovery to commercialization. This helps ensure that each new treatment or technology has the best chance to benefit patients as soon as possible.
Research Approach / Areas of Research:
The Parker Institute imagines a world where cancer is curable and PICI is making this a reality by transforming the way research is done. Utilizing a different approach, the Parker Institute is designed to remove the biggest non-scientific impediments to breakthroughs – insufficient funding and research resources, and disincentives to collaboration. To overcome these barriers, PICI created a new research model to accelerate research and treatment development – a coordinated effort that fuels discoveries with innovative services, tools and resources.
- Strategic Partnerships: Partner with key pharma and biotech companies and tech providers to speed discoveries
- Data Sharing and Collaboration Platform: Build upon each other’s work to do the best science
- Bioinformatics: Create new computing tools that help scientists gather, store and analyze data
- IP Development and Licensing: Provide in-house IP expertise to capitalize on new discoveries
- Shared Research Tools and Infrastructure: Provide leading tools and technologies to fuel major research advances
- Clinical Trials Management: Enable the Company’s scientists to design and lead multi-site trials faster and more efficiently
- Technology Development: Partner with key industry players to create cutting-edge tools and technology
To make the most impact, PICI is focused on a few select research areas that hold the most promise for advancing the field of immunotherapy and helping patients:
- Best-In-Class T-Cells: Advance the next generation of T-cell therapies to provide targeted, safe, long-lasting treatments that can conquer cancer.
- Checkpoint Blockade Response: Uncover the reasons why some patients respond to immunotherapy while others may not, in order to overcome cancer drug resistance.
- Tumor Antigen Discovery: Pinpoint novel cancer cell markers that will become the foundation for new therapies and personalized treatments.
- Tumor Microenvironment: Discover how tumors impair immune cells, which will jumpstart the creation of therapies that can fight hard-to-treat solid tumors.
Role / Responsibilities:
The Medical Director is a critically important role within PICI, effectively serving as “second in command” to the Vice President, Clinical Development and also as a key member of the Clinical Development team. The incumbent will possess cellular therapy expertise and be a recognized clinical expert in cancer immunotherapy who will be responsible for contributing to the design, conduct and execution of clinical trials and ultimately to ensure the safety of the clinical trial subjects and clinical integrity of the trial subject. In addition to study level activities, the Medical Director will participate in defining and shaping the overall clinical trials strategy across the Institute. S/he will also apply comprehensive knowledge of the field to inform clinical research protocols and processes to ensure that participant safety is paramount in the study design. Working within a matrix environment, the Medical Director will work closely with functional groups to ensure that protocol development and implementation follow the safety monitoring plan.
Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Provide medical oversight regarding protocol design, execution and general medical-related study issues.
- Ensure clinical data is generated that meets and exceeds industry standards.
- Oversee multiple different projects and clinical trials.
- Routinely interact with key experts in the field discussing their scientific proposals.
- Review laboratory alerts and coordinate appropriate follow-up with study site.
- Conduct a medical review of the SAP, Project Plan, Tables and Listings, and the
Integrated Clinical Study Reports as appropriate.
- Work with clinical scientists for the data review, who will in turn work with medical writers and statistician for the study design; provide input on the CRF design, etc.
- Conduct training for the project team concerning the disease, drug, study design and
- Provide consultation to the study team during review of out-of-range laboratory values
for clinical and /or protocol significance.
- Preview listings, lab reports, and subject profiles as defined within the Safety Medical
Monitoring Plan and the medical monitoring plan.
- Ensure all protocol inquires and answers are documented.
- Ensure the study is in a continuous state of inspection readiness.
- Play a key role in the interaction with regulatory authorities.
- Have accountability for managing, training and overseeing the activities of Contract Research Organization (“CRO”) medical monitors.
- Work directly with center directors and co-directors to identify areas of unmet medical need, and novel combinations of interest.
- Discuss emerging data from PICI members and assess novel combinations.
- Review available preclinical data that could inform the design of future clinical trials.
- Work with partners such as other non-profit organizations, academic centers and industry to identify projects of mutual interests.
- If required, attend and participate at Investigator Meetings and engage in preparation of subject narratives, review of study reports and other documents, and preparation and/or review of periodic and interim safety reports.
Experience / Qualifications:
- MD degree and Medical Oncology training (Completion of Oncology fellowship (Board eligible/certified)).
- Experience in Immuno-Oncology and awareness of recent developments in the field.
- Experience in cellular therapy and in novel combinations and innovative designs for early phase studies.
- Clinical Development Expertise: a demonstrated understanding of the required steps to progress a new biologic through the stages necessary to allow it to be tested in human clinical trials; ability to ensure high quality in the design, development, execution, statistical analysis, clinical interpretation and reporting of clinical studies.
- Good Clinical Practice (“GCP”) Certification: demonstrated ability to ensure an investigation is conducted according to GCP regulations and internal control documents in order to protect the rights, safety, and well-being of subjects and the accuracy and validity of the trial data.
- A proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate Standard Operating Procedures (“SOP(s)”).
- Scientific & Medical Knowledge: demonstrated current and in-depth understanding of the state of cancer immunotherapy.
- Clinical Data Stewardship: demonstrated understanding of the critical importance of rigorous data generation and disciplined stewardship of the data.
- Medical Monitoring / Pharmacovigilance: demonstrated understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients. An understanding of when to involve the Vice President for Clinical R&D for escalation.
- Scientific Writing: ability to produce written scientific communications with clarity, accuracy and rigor and in compliance with PICI control documents governing disclosure, publication and principles of scientific exchange.
- Scientific Presentation: ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts.
Bench International will identify, screen and conduct initial telephone interviews with all potential candidates with the objective of ascertaining whether or not individuals meet the search criteria. As candidates are deemed appropriate, Bench may arrange for each candidate to participate in completing an assessment tool, specifically designed to predict impact and success in this particular role. Confidential face-to-face meetings will also be scheduled with the candidate and a Bench International representative. The significant other/partner/spouse of the candidate will generally be asked to participate in the process in order to identify professional, educational and/or other relocation issues that would need to be addressed in the event of relocation. Prior to our Client extending an offer, Bench will conduct 360° references and will require verification of the proposed incumbent candidate’s credentials. Depending on the Client's instructions and/or the nature of the position, Bench may also require that the proposed incumbent provide Bench with a signed release authorizing Bench to conduct a background check. Our Client and Bench are dedicated to making this transition viable for the right candidate and all parties concerned.
The salary, bonus and benefit package will be very attractive and highly competitive with prevailing market standards.
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