Associate Director, Project Management Clinical Development

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer. Position Summary:  Reporting to the Executive Director, Process Development and Manufacturing, the Senior Manager or Associate Director, Process Development and Manufacturing is a hands-on technical contributor responsible for designing and executing experiments that support process development and for coordinating and providing technical oversight of contract development and manufacturing organizations (CDMOs). This role supports small-molecule programs from research through clinical development and preparation for commercial production. The Senior Manager or Associate Director may serve as the drug substance lead for one or more programs and works independently and collaboratively to plan, execute, interpret, and communicate process development and manufacturing activities across internal and external teams Essential Duties and Responsibilities: * Independently design, execute, and interpret laboratory experiments to develop robust and scalable chemical synthesis processes for starting materials, intermediates, and APIs * Plan and execute phase-appropriate process R&D activities, including reaction optimization, workup, isolation, crystallization, impurity control, and scale-up * Prepare experimental plans, protocols, technical reports, process descriptions, and data summaries that support project decisions and knowledge transfer * Support technical transfer of starting material, intermediate, and API processes to CDMOs and between external manufacturing sites * Collaborate closely with medicinal chemistry, analytical development, drug product, quality, regulatory, and project management colleagues * Serve as drug substance lead or technical representative for assigned programs, coordinating deliverables, timelines, risks, and technical decisions with guidance from senior leadership as appropriate * Provide day-to-day technical oversight of CDMO development and manufacturing activities, including review of protocols, batch records, data, deviations, investigations, and reports * Conduct impurity fate and purge studies, evaluate potentially mutagenic impurities, and contribute to phase-appropriate drug substance control strategies * Apply Design of Experiments (DOE), Quality by Design (QbD), risk assessment, and statistical approaches to build process understanding and define operating ranges * Support process characterization, proven acceptable range studies, pre-validation, process performance qualification, and validation activities for drug substance manufacturing, as appropriate to program stage * Review proposals and scopes of work from CDMOs and CROs and contribute to technical due diligence, vendor selection, and budget planning * Author and review relevant CMC sections and supporting documentation for U.S. and ex-U.S. regulatory submissions * Share technical expertise with colleagues and may provide project-level guidance or mentorship to junior scientists; direct people management is not a primary responsibility * Travel up to 25% for CDMO oversight, technology transfer, manufacturing support, and other critical project activities * Perform all duties in alignment with the Erasca’s core values, policies, and applicable regulations Required Education, Experience and Attributes: * PhD in organic chemistry or a related field with typically 7+ years of relevant industry experience, or MS with typically 10+ years of relevant industry experience, in synthetic organic chemistry and small-molecule drug development * Strong hands-on experience in synthetic organic chemistry and small-molecule process development, including laboratory execution, data interpretation, and troubleshooting * Experience developing and scaling chemical processes at CDMOs or supporting external manufacturing activities * Experience in chemical development involving synthesis, isolation, and crystallization of chiral molecules preferred * Working knowledge of solid-form development, including polymorph screening, crystallization optimization, and related analytical techniques * Strong knowledge of cGMP and relevant ICH guidelines and an understanding of phase-appropriate drug substance development and control strategies * Experience applying Design of Experiments (DOE), Quality by Design (QbD), and risk-based process development principles * Ability to independently manage technical workstreams, prioritize multiple activities, identify risks, and deliver high-quality work in a fast-paced environment * Ability to build effective working relationships with colleagues and external partners across diverse backgrounds and areas of expertise * Excellent written and verbal communication skills, with the ability to clearly present technical data, conclusions, risks, and recommendations * Collaborative, solutions-oriented, intellectually curious, and willing to contribute as an individual contributor wherever needed * Strong learning orientation, curiosity, and commitment to science and patients   The anticipated salary range for this position is $180,000 to $215,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.    Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program.  Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.     Who we are looking for: Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune programs. The ideal candidate will initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. The successful candidate will report to the Vice President, Clinical Operations. The Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure the successful execution of assigned projects. Experience and knowledge of end-to-end management of clinical trial operations, knowledge of the pharmaceutical industry, and an understanding of clinical drug development and clinical trials operations are essential. Key areas of responsibilities: * Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives * Ensure clinical trials comply with ICH/GCP guidelines, regulations, and company SOPs * Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan * Support the selection, oversight, and management of CROs and other vendors * Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team * Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate * Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations * Assist in forecasting clinical trial material and ancillary supplies * Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures * Ensure timely review of protocol deviations and assess the impact on study data * Along with other Clinical Development personnel, represent Vor Biopharma externally to Investigators, site staff, and Key Opinion Leaders * Perform and document study level Sponsor Oversight of outsourced clinical activities * Communicate study status, cost, and issues to ensure timely decision-making by senior management * Oversee/collaborate and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct * Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vor Biopharma * Support program level deliverables/activities at the discretion of the Head of Clinical Operations * Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise * Oversee or conduct routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs and ensure all appropriate documents are filed * Participate and respond to Quality Assurance and/or regulatory authority inspection audits * Facilitate the development of trial budgets and execution of clinical trial agreements and other relevant documents in conjunction with CRO and appropriate internal stakeholders * Manage the clinical trial budget and provide financial reporting and projections to Finance * Lead creation of scope of work and budgets and escalate vendor performance issues to Head of Clinical Operations and Outsourcing as necessary Qualifications: * BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred * Minimum of 8 years of experience in clinical research with at least 5 years of managing trials in the biotech/pharma industry and/or prior CRO experience * Experience in setup, execution, and oversight/operational management of autoimmune trial experience - Sjogren's and/or Myasthenia Gravis experience preferred * Experience working on late-stage studies (Phase II, III) * Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail * Strong initiative and a can-do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet deadlines, and proven effectiveness in a fast-moving and growing biotech environment * Solid working knowledge of ICH/GCP guidelines and the application to the conduct of clinical trials * Proficient in MS Office Suite and understanding of Clinical Trial Management System, eTMF, and EDC systems, as required * Ability/willingness to travel as required * Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry The salary range for this position is expected to be between $195,000 and $220,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location. At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.