<p>About Servier</p> <p>Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision.</p> <p>Role Summary</p> <p>The Associate Director, Medical Study Operations will oversee operations for Investigator Sponsored Studies (ISS) and Collaborative Research Studies (CRS). The role will report to the Director, Medical Study Operations, Grants & Sponsorships and work closely with the Sr Director, Medical Operations and the Field Medical team. The Associate Director will be the local coordinator responsible for managing Servier's ISS/CRS process. The role will manage the medical study support systems. Collaboration with other team members (e.g. Legal, Ethics, and Compliance, Pharmacovigilance, Supply Chain, etc.) and vendors/alliance management is essential. The Associate Director will be responsible for ensuring studies meet standards and policies and provide timely reports and dashboards on study status to inform relevant stakeholders and leadership.</p> <p>Primary Responsibilities</p> <ul> <li>Lead operations for ISS and CRS, ensuring organized and accessible study information. </li><li>Manage ISS portfolio, including tracking status and facilitating review meetings. </li><li>Coordinate budgeting and contracting for approved ISSs. Oversee individual ISS budgets, study payments, and Sunshine Act reports. </li><li>Monitor site study teams and investigators for protocol compliance and clinical objectives. </li><li>Collaborate with the supply team for clinical trial material requirements and management. </li><li>Maintain project files with all necessary documentation. </li><li>Manage ISS study information in Servier databases. </li><li>Lead ISS program meetings and update Medical Leadership Team on trial progress. </li><li>Track study timelines and manage team to meet deadlines, escalating as needed. </li><li>Create dashboards and metrics for trial progress measurement. </li><li>Follow SOPs, guidelines, and regulations across studies consistently. </li><li>Develop and implement ISS operations, including SOPs and process improvements. </li><li>Represent ISS operations during audits. </li><li>Stay updated on competitive technologies and developments related to Servier products. </li></ul> <p>Education and Required Skills</p> <ul> <li>Bachelor's Degree in scientific, healthcare, or engineering discipline; Advanced Degree (preferred) in relevant scientific field </li><li>5-7 years professional experience with minimum of 3 years relevant Medical Affairs experience in pharmaceutical or biotech industry. </li><li>Must have experience working in Oncology and Oncology therapeutic products </li><li>Well-grounded knowledge of investigator-initiated study principles, processes and systems. </li><li>Experience in both US investigator sponsored studies and collaborative research desired </li><li>Skilled in project management </li><li>Self-organized, self-directing, and initiative-taking </li><li>Effective communication skills, including oral, written and presentation skills </li><li>Excellent interpersonal skills with the ability to work collaboratively in cross-functional teams </li><li>Willing to work in a fast-paced environment with high attention to details and accuracy. </li><li>Excellent prioritization and organizational skills </li></ul> <p>Travel and Location</p> <ul> <li>Estimated travel required: 20% </li><li>Boston based preferred, remote permitted </li></ul> <p>Servier's Commitment</p> <p>Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.</p> <p>All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.</p> <p>Salary Range</p> <p>The salary range for this role is $185,000 - $215,000. An employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.</p> <p>Nearest Major Market: Boston</p>