SVP Clinical Development/Chief Medical Officer
LOCATION: South San Francisco
DIVISION: Clinical Development
REPORTS TO: Head of R&D or CEO
The SVP of Clinical Development or Chief Medical Officer is a highly intelligent, deeply-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. As an executive team member, responsibilities will also include fundraising, investor relations, clinical advisory board formation and management, company building, corporate strategy beyond the clinical function, and significant board exposure. The opportunity exists to build a small clinical team over time. For now, the organizational preference is to leverage a core small team of extraordinary leaders and expand as necessary, using a virtual model.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Initiate and drive multiple clinical studies (Phase 1 through approval) for Day One’s lead clinical program starting in 2020.
- Hands-on medical oversight and conduct of Day One-sponsored clinical trials is the major responsibility, including overseeing study conduct, and ensuring that the clinical and clinical pharmacology components of a high-quality, fast-moving registrational program are in place.
- Design and implement all studies with successful label negotiations, reimbursement, and commercial adoption in mind, in collaboration with all senior development leaders.
- Lead the execution of exploratory combination phase 1b studies and other lifecycle management plans
- Inform and oversee ISTs that represent creative approaches to the generation of potentially registrational data.
- 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 across functions, ensure that clinical development strategy and regulatory accounts for all risks (both known and unknown), benefits, and gaps.
- In the event that it is necessary, define and implement new endpoints for indications that have no standard of care or defined regulatory endpoints, with US and EU regulatory approvals as well as reimbursement requirements.
- Ensure the successful development and implementation of biomarker and diagnostic tools necessary to achieve the scientific, clinical, and regulatory goals of our development programs.
- In collaboration with colleagues in Product Development, design, implement, and execute studies in accordance with applicable Good Clinical Practice (GCP) regulations.
- Medical monitoring, coding, and data cleaning together with clinical operations, drug safety, and product development functions are critical aspects of this role.
- Lead the analyses of study data, including assessing the extent to which studies have achieved clinical, regulatory, and commercial objectives, and documentation of study results.
- Jointly responsible with Product Development for the timely and successful execution of our work through the effective use of CROs and academic partners.
- In collaboration with our scientific leaders, help define the preclinical/translational strategies that will continuously inform our clinical plans, enabling differentiation of our programs, and the potential expasion of our programs to new indications.
- Manage a clinical research budget to plan at an executive level
- Responsible and accountable for integrating the cost, both human and financial, of the execution of clinical deliverables in detail.
- In concert with your colleagues, define the annual plan/budget, manage vendors, and negotiate contracts.
- Build and grow our drug development pipeline
- In collaboration with the CEO, Head of R&D, and Head of BD, inform the decision to buy or license new programs.
- Provide an expert clinical development perspective to inform decisions at the intersection of R&D, corporate development, and future commercial considerations.
- Evaluate of external data in partnership with our advisory network and internal clinical and scientific leaders. This can feel like a fast-paced oncology focused venture capital fund combined with a creative clinical-stage biotech company.
- New insights that will transform pediatric oncology through academic and research institution collaborations and the identification of promising programs through your network are encouraged and highly welcome.
- These responsibilities are secondary to responsibility to drive forward the clinical execution of the lead program and are primary for the Head of R&D.
- Partner with fellow executives to ensure Day One fulfills its mission, grows into an exceptional company, and fosters a creative, fast-pasted, and fun culture
- Lead by example and live our corporate values day to day
- In collaboration with the executive team and board, build the corporate infrastructure and external resources to support the objectives, activities and mission of Day One
- Support fundraising, investor relations, and board meetings
- Drive (not dominating) crisp, high-level decision making on clinical research questions, as well as day-to-day business issues
- Engage, teach, inspire, and successfully communicate with employees of any level in the organization, as well as with our external partners.
- Identify, recruit, mentor, grow, and retain exceptional talent
- Understand and embrace that the most precious asset is our team
- VP, Clinical Development
- Consultants in clinical pharmacology, pharmacovigilance
- Pediatric oncologist or medical oncologist (MD and/or PhD)
- At least 7 years of experience, and demonstrated track record of leadership and success in, oncology clinical drug development.
- Deep expertise in early-to midphase (Phase 1 through Phase 2b) drug development.
- 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.
- Deep understanding of cancer biology, an appreciation for, and understanding of, the importance of translational research in oncology drug development.
- Track record of cultivating and maintaining 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, critical thinking, and prompt follow through.
- Excellent organizational and time management skills, including the ability to independently prioritize one’s own work, enable and drive crisp and effective decision making, and the drive necessary to not only ensure the success of your individual work, but to ensure the success of a team and a company.
- A proactive self-starter who can lead work and manage others independently, with the ability to see the next steps and take action without prompting. Strong sense of urgency and responsiveness to all levels of the organization.
- 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. Comfort with a virtual model for biotech execution and team communication.
- Experience in small companies and with fundraising is preferred but not mandatory. Ability to thrive to a small fast moving environment with both individual contributor and executive level responsibilities.
- Series B+ fundraising experience preferred
- Experience in the interdependencies between HEOR and clinical data is desired.
- Unwavering integrity and trustworthiness, embodying Day One’s core values
- Detail-oriented, organized, efficient and effective
- Extraordinary clinical acumen and a demonstrated track record of success
- Driven and determined and self-starting
- Hopeful and positive, even in the face of challenges, uncertainty, or adversity
- Demonstrates equanimity – works well under pressure and plans personal workload effectively, able to recognize the need to delegate effective to others who are qualified
- Aware that being hands-on and willing to do the work yourself is required in a startup environment
- Creative and resourceful with the ability think far beyond “the way it’s always done” in order to move programs forward quickly. Open-minded when to new ways of thinking and doing outside of traditional drug development and corporate models. Ingenuity to create a path when a prior one has not been created by others.
- Inherent drive to quickly find truth and reach the right decisions through colleagues and collaborators, papers, and evidence from a range of sources
- Able to lead, teach, coach, and work with others in a semi virtual environment
- Inspires the confidence of others, and inspires others to fulfill their potential
- Ability to thrive in a small company environment and to make clear recommendations and crisp decisions
- Eloquent and passionate when talking about new cancer therapeutics and the potential to help patients
- Possessing of a deep network of investigators, collaborators, and partners who are always looking new opportunities to work with you
- Demonstrated success in problem solving
The preceding job description has been designed to indicate the general nature and level of work
performed by employees within this classification. It is not designed to contain or be interpreted as a
comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned
to the job.