Rho Inc

Lead and manage pharmaceutical, biologic, and medical device development programs, including regulatory submissions and strategy. | Extensive experience in pharmaceutical development, regulatory affairs, and leadership in clinical and nonclinical programs, with a PhD/PharmD or equivalent. | At Rho, we are not just a typical CRO; we inspire innovation in the life sciences. Join our dedicated team where curiosity fuels progress, collaboration is encouraged, and every day brings an opportunity to impact the world of clinical research. We are excited to announce an opening for the position of Associate Director/Director of Regulatory Strategy. In this strategic role, you will provide strategic and tactical leadership to Rho clients and project teams in support of our clients’ interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. You will need in-depth regulatory and pharmaceutical development experience and a firm understanding of the dependencies among CMC, nonclinical, clinical pharmacology, clinical, and regulatory for integrated development programs across all phases from pre-phase 1 to marketing application. In addition to serving in a management and mentoring role for Rho scientific personnel, you will also directly serve as Project Leader to manage multiple projects for a range of products, performing project tasks such as developing and tracking project budget, timelines, resources, and deliverables, as well as authoring and reviewing regulatory submission documents for clinical trial applications and marketing applications, clinical protocols and study reports, Integrated Summaries of Safety and Efficacy, regulatory agency meeting packages, and other documents as needed. Key Responsibilities: Serve as an integrated product development and regulatory expert at Rho, responsible for product development activities and services required to support the development programs and regulatory submissions of Rho’s clients, including gap analyses, strategic planning, development of integrated regulatory and clinical strategies and development plans, design of clinical studies, and authorship and review of study protocols, study reports, and regulatory submissions On behalf of Rho’s clients, lead integrated pharmaceutical, biologic, and medical device product development programs consisting of clinical, nonclinical, chemistry, manufacturing and controls, and regulatory components Provide leadership, guidance, and support to teams, programs, or projects of large scope, as well as to the Program Management discipline within the company Mentor and advise staff in areas of expertise by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members Proactively identify risks and critically analyze problems affecting the programs and develops contingency plans as needed Facilitate achievement of strategic goals for a program Monitor ongoing progress of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans Ensure effective, accurate and timely communication of key issues and progress to project stakeholders and senior management Manage the strategic, regulatory authorship, biostatistical, and data submission components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with all requirements related to electronic submissions Author Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other complex regulatory documents Develop and review clinical study protocols, investigator’s brochures, clinical study reports, and other key clinical development documents Lead the planning, preparation, and conduct of regulatory authority meetings, and participates in discussions with regulatory authorities as appropriate Manage scope of work, budget, and timelines for external vendors, including consultants, external medical writers, nonclinical toxicology houses, and other vendors Moderate regulatory authority meetings Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; serve as a proposal leader for commercial proposals with specific responsibility for the development and articulation of the technical strategy sections of the proposal; provide guidance and input to the budgets and business submissions of proposals Mentor other technical leads in business development and proposal creation activities PhD/PharmD or equivalent demonstration of analytical ability and a minimum of 5-8 years in development programs that include inter-related clinical, nonclinical, CMC and regulatory experience; Regulatory Affairs Certification (RAC) desired Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) desired Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company; proven ability to establish credibility with professionals on program teams Ability to understand and motivate others and build effective teams; ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure Excellent presentation and critical thinking skills Ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self) Proficient in advanced techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave. Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work. As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $180,000-$220,000 per year. EOE. Veterans/Disabled

Provide medical, scientific, and regulatory guidance across clinical trial projects, ensuring safety, compliance, and scientific integrity. | Must have a medical degree, active medical license, and 5+ years in clinical medicine and development, which you do not possess. | Join us in redefining what it means to work for a CRO. When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do. Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other. You’ll have the opportunity to experience a thriving global company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. We are currently hiring a Medical Director with a specialty in Pulmonary as well as General Medicine to join our team! As a Medical Director, you will have the opportunity to provide medical, clinical, and scientific advisory expertise across multiple therapeutic areas, to all Rho project teams. You will also consult with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensure the scientific and ethical integrity of clinical trial design and conduct; provide medical input to clinical programs; and provide clinical development and regulatory input as needed. Our Medical Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group! This role can be located remotely anywhere in the United States. The level of Medical Director is dependent on your level of expertise. What you’ll be doing Serve as Medical Advisor on assigned projects. Provide medical support to investigative sites and project staff for protocol-related issues. Perform review and clarification of trial-related Adverse Events (AEs) and coding. Perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives. Perform medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). Perform medical review of the Clinical Study Report (CSR), patient narratives, and other high-profile documents such as marketing application, clinical safety/efficacy summaries and overviews. Serve as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. Participate in the development of Medical Monitoring portion of client proposals including the budgeting process. Support Business Development activities by reviewing and providing medical/scientific input and guidance on Requests for Proposals (RFP), as well as being an active participant and Rho representative at bid defense and other meetings with sponsors. Support Feasibility activities as required. A medical degree from a fully accredited medical school as well as holding (or having held) an active medical license in good standing 5+ years of experience in clinical medicine beyond residency and 5+ years of clinical development experience (ideally in the pharmaceutical or a closely related industry) Good understanding of research methodologies and clinical trial design, including biostatistics Good understanding of scientific and ethical regulations and guidelines pertaining to clinical research, including knowledge of federal drug development regulations and guidelines Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility Ability to establish and maintain cooperative and effective working relationships with coworkers, managers, and clients Excellent communication and interpersonal skills, ideally with experience/expertise in public speaking and engaging external stakeholders A few more things to know about us: Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave. Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work. EOE. Veterans/Disabled

Lead and manage complex global clinical trial projects, prepare project plans, manage resources and budgets, mentor team members, and collaborate with customers to deliver high-quality results. | Minimum 5 years managing clinical research projects with knowledge of clinical research regulations and therapeutic expertise preferred, strong communication, quality focus, and adaptability. | Join us in redefining what it means to work for a CRO. When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do. Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other. You’ll have the opportunity to experience a thriving global company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. We are currently hiring a Sr. Project Manager to join our team! As a Senior Project Manager here at Rho, you’ll have the opportunity to grow your career and provide leadership to cross-functional clinical research projects and team members. You’ll need to provide on-time, on-budget, and high-quality project results as well as motivating, training and mentoring team members and helping develop new superior customer experiences while maintaining Rho’s core values, including Teamwork, Quality, Great People, among others. We’re looking to you to bring your expertise, leading complex projects and developing junior staff. Bring that, and you’ll experience professional growth, career and financial rewards, and long-term stability. Therapeutic expertise in any of the following is preferred: post-surgical pain, respiratory conditions, psychiatry, Parkinson's Disease and/or food allergy. Our Project Managers will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group! This is a remote position within the US with the willingness to travel for sponsor visits, meetings and trainings, as needed. Responsibilities • Lead large, global, and/or complex clinical trial projects, conceptualizing the execution strategy for each component project • Prepare project management plans and other governance documents • Recommend and implement operational strategies as well as risk management plans • Manage assigned project resources, including ensuring that project tasks are correctly assigned to staff and vendors • Manage project and vendor budgets and scope of work, including recognizing and negotiating changes in scope • Make tactical recommendations to customers to improve projects and provide strategic and tactical guidance to team members • Mentor and provide training and orientation for team members • Manage team dynamics and provide frequent feedback to team members • Collaborate with customers to provide win/win solutions • Contribute to business development initiatives, including proposals, responses to RFIs, and bid defense presentations Requirements • BS in life sciences or related field along with Minimum 5 years’ experience managing progressively larger and more complex clinical research projects; therapeutic expertise in any of the following is preferred: post-surgical pain, respiratory conditions, psychiatry, Parkinson's Disease and/or food allergy • Solid understanding of applicable clinical research and scientific concepts and regulatory requirements; e.g. Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, regulatory agency regulations; Ability to interpret study protocols and designs • Experience in conducting on-site monitoring visits and/or managing activities of a CRA team to achieve project deliverables • Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s. • Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome. • High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another. • Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions. • Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us. Benefits A few more things to know about us: Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave. Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world. Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work. As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $110,000-$150,000 per year. EOE. Veterans/Disabled