Asher Biotherapeutics, Inc. is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Our cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies. Our approach has the demonstrated potential to precisely direct different immune mediators to a range of target immune cell-types, enabling a pipeline of best-in-class immunotherapies in cancer, autoimmune and infectious diseases that we anticipate will bring great benefit to the lives of patients.
We are looking for a Director/Senior Director of Clinical Operations to lead one or more of AsherBio’s clinical programs to ensure completion per established corporate goals and objectives. The Director/Senior Director of Clinical Operations will report to the Chief Medical Officer and will work closely with a cross-functional team in a fast-paced high growth environment to ensure that clinical trials are conducted on time and within budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements. Responsibilities
- Provide leadership, oversight, and line management for early-stage oncology program to ensure clinical trials are conducted in accordance with the protocols, timelines, and budgets
- Develop, implement, and provide oversight of study and program budgets, including CRO/vendor budgets and contracts, with a planning horizon of 12-24 months
- Lead the team in the selection of Contract Research Organizations (CROs) and vendors
- Effectively communicate expectations to CROs and serve as key escalation point for the study teams
- Oversee scope, quality, timelines, and budget, working with internal functional leads, CROs, and other vendors to ensure overall project objectives are met
- DJMember of the Core Team, providing strategic operational input to efficiently meet corporate objectives
- Present to the Executive Leadership Team on trial progress, budget development and forecasting, and changes in scope
- Identify and mitigate risks to study implementation, enrollment, conduct, compliance, budget, and completion
- Develop and manage effective working relationships with Investigators and other key clinical opinion leaders
- Contribute to the development of clinical documents (protocols, ICFs, Investigator Brochure, monitoring plans, cohort management plan, pharmacy manual, etc.)
- Contribute to the establishment of clinical operations SOPs, Work Instructions, guidelines, standards, and best practices
- Participate as a functional contributor to due diligence/business development evaluations including the review of external clinical development plan (CDP) and strategy, the development of internal timelines, budget estimations and resources needed to support the CDP
- Ensure compliance with all applicable regulatory requirements, including FDA regulations, ICH guidelines, and GCP standards.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
- Bachelor’s degree required
- 15+ years industry experience, including 8+ years managing trials with CROs
- Strong leadership skills with ability to be hands-on to fill gaps as needed and lead/manage the clinical operations team
- Experience with direct line-management of clinical operations staff
- Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors
- Experience with financial forecasting, budgeting and reporting
- Experience in early phase clinical trials in oncology is strongly preferred
- Able to set priorities, juggle multiple demands, and manage changing priorities
- Has a thorough knowledge of the clinical trial development process and Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and abroad
- Strong communication (verbal, written, listening) and interpersonal skills with the ability to communicate effectively with investigators, vendors, and individuals across different levels of the organization, including executive leadership team
- Travel may be required up to 10% in both the U.S. and abroad
Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.SF Bay Area Salary Range $228,000—$315,000 USD
Vaccine Mandate
Employees working in this position will be required to be fully vaccinated against the COVID-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such s the Pfizer or Moderna vaccines or two weeks after a single-dose vaccine, such as Johnson & Johnson's Janssen vaccine. Applicants will be required to show proof of vaccination status upon receipt of a conditional offer of employment. Any offer of employment will be conditional upon, among other things, an Applicant's ability to show proof of vaccination status.
Please note that the Company provides reasonable accommodations in accordance with applicable state, federal, and local laws.
About Asher Bio/Mission
In ancient Hebrew the name “Asher” means happy, blessed and fortunate and is reflected in our mission of restoring hope, health and happiness in the lives of patients. Every day the name above our door, on our business cards and at the bottom of our emails reminds us of our purpose and we invite you to join us on our quest as we focus on advancing differentiated, transformational immunotherapies. By precisely targeting immune cell subtypes, we are setting ourselves apart from the crowded conventional approaches. Our core technology can selectively harness specific cells of the immune system to optimize both efficacy and tolerability.
We are developing this discovery while remaining focused on our guiding principles. We incorporate inspiration and rigor into our strategic decisions while transforming plans Into action with enthusiasm. We are committed to teamwork; aiming to support and challenging each other to become better while striving for a seamless collaboration across all functions and business processes. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
