VP/SVP of Clinical Development or CMO

Company: Day One Biopharmaceuticals
Location: San Francisco
Posted on: March 28, 2020

Job Description:

Day OneAdvances in cancer research now enable drug developers to identify children and adults who may benefit from the same medicine. Day One Biopharmaceuticals is a unique company that was created to identify and develop new therapies that would meet the critical needs of patients of all ages with cancer by starting from the biology of childhood cancer. Our distinctive approach, together with our trusted network of pediatric oncology investigators, gives us an unparalleled ability to identify and advance promising discoveries and therapies for patients of any age.Day One was incubated at Canaan Partners, funded by Atlas Venture and Access Industries, and intentionally built to accomplish this unique mission. Our goal is to build a robust pipeline by identifying high-value targets and mechanisms that leading pediatric investigators guide us to, finding and in-licensing late-preclinical and clinical-stage assets, and then executing a focused clinical development plan rapidly in order to bring new cancer products to waiting patients of all ages. It is a distinct, mission-driven model of drug development. Day One acquired its first clinical stage product in December 2019 and is evaluating many more preclinical and clinical compounds.VP/SVP of Clinical Development or CMOSeeking an intelligent, committed, high-integrity pediatric or medical oncologist with a proven track record of successfully and efficiency advancing oncology therapeutics into and through all phases of clinical development. For our lead program, you are accountable and responsible for the clinical, regulatory and, commercial objectives necessary to change the standard of care for the patients we serve. This includes the final design, implementation, and oversight global clinical development plans to advance a targeted oncology program towards approval for use in pediatric and adult cancer patients. Driving DAY101"s clinical plans forward rapidly, effectively, and compliantly is your top objective for 2020. The clinical development plan and budget includes multiple trials including proof of concept phase 1b combination studies, single agent registrational trials and novel ISTs. These are also the top corporate goals for the organization.Close partnership with the Head of R&D to define the initial clinical strategy, translational plans and fast-to-market strategy across all ages for each of our current and future programs is a core aspect the role. The Head of R&D is another MD/PhD whose super-power is designing creative clinical development strategies and translational plans for any given target that bring products to market years faster than other pharmaceutical companies, by including both children and adults with cancer.For SVP and CMO candidates, as an executive team member your responsibilities will also include fundraising, investor relations, SAB formation and management, company building, corporate strategy beyond the clinical function, and significant board exposure. The position reports to the Head of R&D or CEO accordingly. For this position, if not titled immediately as the CMO, the candidate must have the potential to grow into that role over time, and with executive mentoring.Responsibilities:Initiate and drive multiple clinical studies (phase 1 through registrational) for Day One"s lead clinical program starting in 2020, in order to change the standard of care for patients of all ages living with cancerLead the end-to-end design of clinical development plans and modern clinical trials. Design and implement the registrational studies with successful label negotiations, reimbursement, and commercial adoption in mind in collaboration with all senior development leaders. Hands-on medical oversight and conduct of Day One-sponsored clinical trials is a major responsibility. -The incumbent is expected to be the primary clinical point of contact for clinical trial staff at study sites, as well as for regulatory, safety and product development and other functions requiring clinical input.Working with across functions, ensure that we have comprehensively thought through the clinical development strategy and regulatory strategy, risks (both known and unknown), benefits, and gaps. You will be responsible for making sure that we have planned for and completed all of the clinical and non-clinical development work required to ensure safety and success of our development programs (including safety, clinical pharmacology, PK/PD, ADME, combination and lifecycle plans) by overseeing and managing clinical development plan design, study design, and execution.In the event that it is necessary, define and implement new endpoints for indications that have no standard of care and no defined regulatory endpoint, keeping in mind objectives for US and EU regulatory approvals as well as reimbursement requirements.In collaboration with your colleagues in Product Development, implement and execute studies in accordance with applicable Good Clinical Practice (GCP) regulations. Leading medical monitoring, coding, and data cleaning together with clinical operations, drug safety, and product development functions are key aspects of this role. You will be expected to lead the analyses of study data, the assessment of the extent to which studies have achieved clinical, regulatory, and commercial objectives, and the documentation of study results. You are jointly responsible for the timely and successful execution of our work through the effective use of CROs and academic partners.In collaboration with our scientific leaders, you will define the preclinical/translational strategy that quickly informs the clinical plan, enables differentiation of our programs, and expands the potential of our programs to improve as many patients" lives as quickly as possible.Manage a clinical research budget to plan at an executive levelAs part of defining a clinical development plan and associated studies, you will be responsible for integrating the cost, both human and financial, of research into your plans.In concert with your colleagues, define the annual plan/budget, manage vendors, and negotiate contracts with your team.Build and grow our drug development pipelineIn collaboration with the CEO, head of R&D, and head of BD, you will inform the decision to buy or license new programs. You will provide an expert clinical development perspective to inform decisions at the intersection of R&D, corporate development, and future commercial considerations, all the while being able to effectively communicate this balance.You will be asked to provide your opinion when evaluating of external data in partnership with our advisory network and internal clinical and scientific leaders. This job can feel like you work in a fast-paced venture capital fund combined with a creative clinical-stage biotech company.Qualifications and Experience:The ideal candidate is a high integrity physician or physician-scientist (MD or MD/PhD) with a track record of successfully developing cancer therapeutics. The candidate could be either a pediatric oncologist or medical oncologist.At least 7 years of demonstrated track record of leadership and success in oncology clinical development. Deep expertise in early-to-mid (Ph1 through Phase 2b) phase drug development is an absolute must. Strong writing skills and a track record of leading the development of study protocols, as well as global regulatory documents including INDs, IBs, NDAs, PIPs, iPSPs, and CTA/IMPDs. Phase 3, filing, and life-cycle experience is highly desired. A solid background and experience in drug development and life-cycle development is essential, including defining "go/no-go" decision points, timelines, and resources in alignment clinical and corporate development strategy. Experience in the interdependencies between HEOR and clinical data is desired. The candidate must have a deep understanding of cancer biology, an appreciation for, and understanding of, the importance of translational research.A strong understanding of how to optimize development of a drug for approval and commercialization based upon unmet medical needs and asset value. The candidate must also have an understanding of the nuances of cancer drug development, from candidate selection through filing, including the decision-making required to build and manage a drug development programs in a small company.The ability to lead clinical, scientific, and business discussions internally and externally and explain scientific/medical concepts to people at all levels. The ability to cultivate and maintain relationships with key opinion leaders in the relevant fields and the ability to establish trust internally and externally through the consistent demonstration of scientific expertise and satisfactory follow-throughStrong presentation and communication skills, including the be able to provide clear, succinct, strategic, decisive, and actionable insights to colleagues, investors and senior executives.A track record of identifying, vetting, selecting, managing, and working with external resources including clinical CROs, CDx vendors, imaging CROs, drug safety/PV vendors, and contract medical writing groups.Start-up/small biotech (A successful track record of participating in fundraising (Series B and beyond), and a demonstrated ability to build a small, world-class team is highly desired.Pediatric oncology, rare disease, and/or translational experience is a strongly desired.You will be based in SSF with temporary office in SF (SOMA) and are able to travel up to 25% of your time.

Keywords: Day One Biopharmaceuticals, San Francisco , VP/SVP of Clinical Development or CMO, Other , San Francisco, California