Clinical Research Associate I/ Clinical Research Associate II

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us. Field Territory Coverage: Preferred candidate will reside in NC, SC, GA, TN or KY, and near a major airport hub such has Atlanta, Nashville, Raleigh, Charlotte or similar location. Employee Value Proposition: Exciting opportunity to join a medical field team and collaborate with a dynamic and growing Medical Affairs Department.   Position Summary: The Associate Director, Medical Field is a field-facing representative of the Medical Affairs Department with a primary responsibility to engage in the exchange of scientific data, education of health care practitioners on Taiho products and relevant disease states, and facilitation of clinical research. The Associate Director, Medical Field integrates clinical and scientific knowledge at an advanced level to ensure the successful implementation of the medical affairs strategic plan within an assigned geographic region. The Associate Director, Medical Field brings relevant insights from the field on research developments, treatment landscape, and new concepts in medical treatment. The role of the Associate Director, Medical Field is non-promotional in nature.   Performance Objectives: Product/Therapeutic Area Support to External Stakeholders: * Acts as the primary clinical/scientific resource to Health Care Professionals (HCPs) in a specified geography for information about the disease state and Taiho's product(s) and compounds to ensure awareness and understanding. * Provides high-quality scientific information to HCPs. * Serves as a conduit for accurate and updated clinical, scientific, and medical information between Scientific Leaders (SLs)/investigators, and the company's Medical Affairs and development groups. * Establishes, fosters, cultivates, and maintains peer relationships with SLs and HCPs in the therapeutic areas in which Taiho has current and future interests. * Shares expert knowledge and participates in scientific exchanges and interactions with identified SLs and HCPs. * Presents clinical and scientific data on Taiho’s products and relevant therapeutic areas as requested. * Identifies and reports key scientific, clinical, research, and competitive key insights from SLs b, and HCPs to the internal Medical Affairs organization. * Responds to unsolicited medical information requests from the field. * Fulfills Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. * Uses medical affairs plans to develop and align the field tactical plan for Associate Director, Medical Field geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, e.g., medical territory, engagement plans/ SL/HCP Rosters.   Training/Education Resource: * Develops, maintains and demonstrates scientific expertise and a strong knowledge of hematology-oncology and solid tumors disease states which are of interest to Taiho Oncology, study methodology, GCP, clinical information, and product data. * Demonstrates full knowledge of and ability to execute on approved medical platforms/strategies and initiatives. * Serves as technical/scientific subject matter resource to Taiho commercial personnel, if requested. * With minimal assistance, independently manages SL and HCP engagements in the assigned territory. Research Support: * At the local level, identifies opportunities for collaboration in Real World Evidence with internal Medical Affairs personnel. * In collaboration with Medical Affairs personnel supports data generation in Investigator-Initiated Trials (IITs) and SL/HCP initiated projects. * Facilitates the review and follow-up of submitted IITs in assigned territory with a knowledge of IITs ongoing in other territories. * Assists with Taiho sponsored trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and communication of scientific insights for specific studies from clinical sites to internal TOI stakeholders.   Professional Organization Support: * Works in conjunction with the appropriate internal matrix team to support Taiho’s collaboration and engagements with professional organizations/societies & advocacy groups, GPOs, and large networked practices. * Collaborates with internal colleagues and SLs/HCPs on Medical Affairs initiatives including publications as requested, advisory boards, medical meeting support, medical education opportunities, training, speaker development, etc. * Has a positive attitude and “can do” approach to self-motivate and be a role model to other team members. * Is influential in supporting medical field team members to meet Medical Affairs goals. * Actively participates in internal Medical Affairs team calls and post-congress debriefs.    Project Support: * Works with Medical Affairs Field leadership in project development and implementation. * May participate in internal Medical Affairs project(s).   Education/Certification Requirements: * A terminal D degree (i.e., MD, PharmD or PhD) in medical or health sciences is preferred.   Knowledge, Skills, and Abilities: * A minimum of 3 years of experience in the pharmaceutical industry with at least one year of field-facing experience. * A minimum of 3 years’ Medical Field experience or similarly related experience is preferred. * At least 1 year of Oncology Medical Field experience is required. * A minimum of 5 years of relevant therapeutic area expertise in solid and hematologic malignancies in a scientific or clinical setting is preferred. * Knowledge of oncology SLs, HCPs, and institutions in geography to be covered is preferred. * Clinical trial development experience is preferred. * Knowledge of treatment guidelines, clinical research processes, FDA regulations and OIG guidelines are required. * Excellent interpersonal communication and presentation skills are required. * Ability to network and partner with important external customers, including medical thought leaders, academic institutions, large group practices, medical directors, and pharmacy directors is required. * Demonstrated ability and experience working cross-functionally, as well as influencing and negotiating at all levels within the organization. * Demonstrated ability to anticipate, organize, plan and handle multiple changing priorities. * Demonstrated ability to work independently while adhering to Medical Affairs strategic direction. * Demonstrated proficiency in communicating upward, downward and laterally, verbally and in writing. * Demonstrated high level of ability in SLs/HCPs engagement. * Demonstrated ability to analyze complex situations and proactively identify opportunities/issues; effectively solve problems that cross functional boundaries. * Committed to the concept of team and working within the framework of the Medical Affairs Department and Taiho organization, including as it pertains to compliance with policies, systems and practices.  * Possesses and maintains a valid driver’s license. * Ability to read, analyze and interpret scientific and technical information and data. * Excellent English communication skills, both verbal and written. * Requires operational proficiency with power point, word and excel. * Demonstrated ability to work with software tracking/logging systems. * Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends. * This is a field-based position. The employee is required to set up a home-based office. * Domestic and international travel may include spending time at cancer trial sites/institutions, conference center, offices and hotels.  * Associate Director, Medical Field must live in the assigned territory.     The pay range for this position at commencement of employment is expected to be between $199,750- $235,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.   If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #Georgia-United States #LI-Remote

About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world. Team Description: The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people! Job Description and Responsibilities: As a Clinical Research Associate, you'll play a crucial role in pioneering groundbreaking clinical studies. Your work will directly contribute to the planning, execution, and success of innovative trials, from the initial phases of study setup to hands-on clinical monitoring and site management. You'll be visiting sites both in-person and remotely to ensure protocol and regulatory compliance, tackle safety event management, and maintain essential documentation. Collaborating closely with a passionate, cross-functional team, as well as external partners, you'll be at the forefront of Neuralink's mission to push the boundaries of what’s possible in clinical research. Additional job responsibilities will include: * Conduct site initiation, interim monitoring, and close-out visits (remote and on-site) * Ensure clinical studies are conducted in accordance with protocol, GCP, ISO 14155, and applicable regulatory requirements (e.g., 21 CFR Part 812) * Verify the accuracy, completeness, and consistency of clinical trial data through source data verification (SDV) and source data review (SDR) * Monitor participant safety by reviewing adverse events (AEs), serious adverse events (SAEs), and device deficiencies for completeness and timeliness * Ensure sites maintain adequate regulatory documentation, including Investigator Site Files (ISF), informed consent forms, and essential documents * Track site performance, enrollment, and data quality metrics; proactively identify risks and implement mitigation strategies * Support site training on protocol, investigational device use, and study procedures * Collaborate cross-functionally with Clinical Operations, Data Management, Regulatory, and Quality teams * Ensure timely resolution of data queries and protocol deviations * Prepare and maintain monitoring reports and follow-up letters in accordance with timelines * Support audit and inspection readiness at the site level Required Qualifications: * Bachelor’s degree in life sciences, engineering, or related field * 5+ years of clinical research experience (device experience strongly preferred) * Working knowledge of GCP (ICH E6), ISO 14155, and applicable FDA regulations * Experience with electronic data capture (EDC) systems and clinical trial documentation * Strong understanding of clinical trial processes, including monitoring and site management * Excellent communication, organization, and problem-solving skills * Ability to work independently in a fast-paced, evolving environment * Up to 30% travel (domestic and occasional international) Preferred Qualifications: * Experience in neuromodulation, implantable devices, or other Class III medical devices * Experience supporting IDE or PMA clinical studies * Familiarity with risk-based monitoring approaches * Exposure to early feasibility or first-in-human studies * Exposure to market approval studies * Willingness and ability to travel up to 30–50% (domestic and occasional international) Expected Compensation: The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees. Base Salary Range: $89,000—$148,000 USD What We Offer: Full-time employees are eligible for the following benefits listed below. * An opportunity to change the world and work with some of the smartest and most talented experts from different fields * Growth potential; we rapidly advance team members who have an outsized impact * Excellent medical, dental, and vision insurance through a PPO plan * Paid holidays * Commuter benefits * Meals provided * Equity (RSUs) *Temporary Employees & Interns excluded * 401(k) plan *Interns initially excluded until they work 1,000 hours * Parental leave *Temporary Employees & Interns excluded * Flexible time off *Temporary Employees & Interns excluded