<p>Director, Clinical Operations</p> <p>Seismic Therapeutic is a biotechnology company making a major shift in how immunology therapies are discovered and developed, enabled by machine learning. The company has a growing clinical and preclinical best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life sciences investors and is located in the Boston biotechnology hub.</p> <p>We are seeking an experienced and motivated Director of Clinical Operations who will play a critical role in the planning, execution and management of Seismic's clinical studies. You will oversee the day-to-day clinical trial operations and contribute to planning of the overall clinical development strategy for our clinical and IND-enabling stage programs.</p> <p>Who You Are:</p> <ul> <li>An experienced clinical operations and clinical trial management professional ideally having experience with biologics development, immunology therapeutic areas and/or rare disease </li><li>Passionate about improving the lives of people living with immunological diseases </li><li>Strong interpersonal skills to influence and motivate others, reach organizational alignment and manage conflict, including collaborating with scientists and functional experts across multiple levels and working styles </li><li>Exceptional organizational skills, with ability to manage multiple cross-functional projects </li><li>Proactive and "roll-up your sleeves" mindset to dive in with minimal supervision and thrive in a fast-paced, fluid environment </li><li>Excited to help define and build the clinical operations function for a growing and exciting pipeline </li></ul> <p>What You'll Do:</p> <ul> <li>Achieve clinical milestones and critical corporate objectives by partnering with cross-functional Development team (including senior R&D leadership, Clinical, Preclinical Translation, CMC, etc.) </li><li>Work collaboratively with and manage CRO partners including responsibilities for day-to-day coordination of activities, creation and oversight of clinical study documents, deliverables, risk mitigation </li><li>Establish relationships with clinical trial sites to help ensure high quality data collection, timely study recruitment and enrollment, and compliance with regulatory standards </li><li>Ensuring adherence to global regulatory requirements and Good Clinical Practices </li><li>Develop and manage study budgets including tracking and reconciliation, balancing achievement of milestones with financial stewardship </li><li>Brainstorm and articulate clinical timeline and operations scenario plans and work collaboratively with cross-functional team to understand implications of decisions </li><li>Collaborate with functional experts to address issues and challenges, including proactively identifying and creating mitigation/contingency plans for program risks </li><li>Support development of integrated strategy including articulating long-term product strategies, functional plans and interdependencies </li><li>Provide input into developing quality systems including SOPs and other resources </li><li>Contributing your expertise to build clinical development capabilities and support business operations as needed across the organization </li></ul> <p>Qualifications:</p> <ul> <li>BS in scientific field required; advanced degree preferred </li><li>~10 years of experience in a biotechnology or pharmaceutical setting and at least 5-7 years in clinical operations/clinical trial management with demonstrated results in a fast-paced environment, ideally in both large and small, companies </li><li>Experience with CRO/vendor selection and management </li><li>Strong command of GMP requirements and ICH/GCP guidelines and global clinical trial regulations </li><li>Strong analytical and technical skills, including proficiency in project management practices, project planning, and decision-making </li><li>Clear communication skills with ability to articulate complex strategic considerations and influence discussions to address challenges and reach decisions </li><li>Experience with biologics in immunologic diseases and/or rare disease is preferred </li></ul> <p>At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that.</p> <p>As a member of our diverse and growing team, you'll help shape Seismic into a company that takes its scientific mission seriously while providing a positive and supportive workplace environment and culture. With your insights, passion and talent - we'll bring novel therapeutics to the patients who need them the most.</p> <p>Seismic Therapeutic is an equal opportunity employer. We will not tolerate discrimination on the basis of race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran's status, pregnancy, genetic information or on any basis prohibited by federal, state or local law.</p>