Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.
We are seeking a Senior Director/VP – Clinical Development (SD/VP, CD) who will be responsible for developing and executing the clinical strategies for Synthekine’s oncology programs. The SD/VP, CD will be responsible for leading clinical programs and delivering innovative, high-quality clinical study designs and development plans. He or she will integrate with internal and external clinical operation teams responsible for the day-to-day execution of the clinical programs. The SD/VP, CD will be responsible for scientific leadership of internal and external staff in biometrics (biostatistics and data management) and medical writing. The SD/VP, CD will work with the CDO to represent clinical activities on all cross-functional project teams. In addition, he or she will be responsible for communicating progress against the clinical development and translational biology plans and for obtaining guidance and approval of program parameters from the Leadership team as appropriate. The SD/VP, CD will be responsible for the resourcing and budget planning and integration into department and company strategic and financial objectives.
- Work closely with the Chief Development Officer (CDO) and other team members to generate the Clinical Development Plan (CDP) to include integrated regulatory and biomarker strategies and incorporating efficient / innovative study designs and methodologies through cutting-edge medical and clinical development knowledge. Integrate the CDP into the execution plans within the compound development teams.
- Manage and lead the day-to-day cross functional clinical development team including chairing the clinical development team meetings
- Accountable for all aspects of clinical biomarker development, including external and internal novel biomarker development.
- Lead a cross functional team to execute according to the CDP and in manner consistent with GCP requirements and internal compliance processes.
- Develop and implement strategies, in conjunction with project and study teams and in accordance with SOP, GCP and regional regulations, to identify, monitor and resolve clinical program/trial operational issues.
- Manage and collaborate with external (and internal) medical monitors and safety teams to safeguard patient safety in studies through excellence in design and ongoing safety/medical monitoring during study conduct and follow-up.
- Identify, engage and manage appropriate internal and external program resources in Clinical Pharmacology, Biostatistics, Clinical Operations (and other areas as needed) to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
- Serve as Subject Matter Expert to management, other functions (e.g. marketing, research), and regulatory agencies; helps set strategy for Advisory Boards, and build strong relationships with KOLs.
- Provide scientific leadership for regulatory documents creation (e.g., briefing books, INDs, NDAs etc.)
- In partnership with CDO, represent Clinical programs in discussions with Health Authorities as appropriate.
- Accountable for the primary authorship of clinical documents (e.g. protocol, clinical report, clinical components of regulatory submissions [integrated summary of safety, efficacy, clinical overview]) in concert with the CDO and other team members.
- Work with external QA consultants and internal department heads/staff to ensure Quality Systems are advanced in step with, and in a manner appropriate to, the active stage of clinical development to ensure company remains in compliance with all relevant regulations.
- Establish relationships with key external clinical experts and institutions to ensure implementation of latest clinical thinking and guidelines into clinical development plans, and to establish collaborations for research innovation.
- Represent the company at scientific meetings and presentations, interactions with disease foundations, as well as other public relations opportunities, in partnership with the CDO.
- Collaborate with scientists across the organization to develop comprehensive publication strategy to support the compound.
- Work with the CDO to set overall department resourcing and budget plans, integrating clinical program strategies, and overall company objectives.
- Set overall deadlines for projects within function and track project milestones
- Integrate and implement new resources (tools, systems, vendors, etc) and techniques with existing ones, in a stage-appropriate manner.
- Manage contractors, consultants and vendors to complete assigned work according to agreed upon timelines, costs and quality expectations.
- Participate in the recruitment, selection, performance, and succession planning activities.
- Represent the clinical department to the company leadership team and governance bodies. Identify and escalate issues as appropriate and guide contingency planning with solutions focused mindset.
- Develop data to support patent filings, and interface with intellectual property team.
- MD with 5 or more years of industry experience, specialty training in medical oncology or equivalent OR
- PhD with 10 or more years of industry experience or equivalent experience in academic clinical trial management and specialty training in medical oncology or equivalent
- Prior clinical experience in phase 1-3 studies in oncology as clinical investigator or monitor / clinical director
- Active scientist able to provide detailed guidance to clinical investigators
- Comprehensive understanding of the drug development process and a proven track record of success in executing development programs
- Understanding of clinical regulatory requirements; experience in driving successful regulatory interactions preferred. Working knowledge of ICH guidelines, relevant regulatory guidance, and GLP, GMP and GCP procedures.
- Expertise in biomarker development, validation and utility and continued engagement in nonclinical and clinical biomarker development and implementation.
- Strong focus on finding innovative ways to promote exploratory technologies and methodologies, leverage external expertise and funding, and pursue adjacent scientific areas if appropriate.
- Successful track record in planning, conducting and publishing of discovery and/or clinical science.
- Expert cross functional collaboration and leadership skills, including active development and maintenance of a close working relationship with functional, leadership, and governance team members to assure a closely coordinated program of activities based on common objectives
- Skilled at influencing decision making; ensure functional team discussions/activities lead to resolution and are in alignment with the strategy
- Ability to engage in research and development planning and technical execution appropriate to clinical research, translational biology and biomarker development at all stages of the drug development pathway.
- Acts with a sense of urgency; retains an ability to act with grace and resilience under pressure
- Good project management skills; ability to track and influence multiple activities lead by various functional sub-teams to ensure deliverable of key milestones
- Experience in developing budget and resource plans for development programs
- Good communication (written and verbal) and presentation skills
- Strong time management, interpersonal and organizational skills
Please apply at email@example.com.
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.