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Director, Clinical Operations - Immunology
Location: Boston, MA
Monte Rosa Therapeutics is seeking a highly experienced Clinical Operations professional to lead the successful planning, implementation, and conduct of clinical trials across multiple indications. Reporting to the Head of Clinical Operations, the Director, Clinical Operations will be responsible and accountable for development of operational program strategy and leading execution of First in Human through Phase III trials depending on program lifecycle, representing clinical operations on cross functional Core Teams, and managing clinical operations team members to ensure adherence with overall study timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs). A genuine interest and understanding of the science supporting the MRT pipeline, an ability to work in a multidisciplinary team setting, and a commitment to developing new treatments for patients are critical for success.
Key Responsibilities:
Skills & Qualifications
Bachelor's degree in health sciences or related field.
Minimum of 10 years of global clinical trial and program operations experience with at least 4 years of independent clinical trial management through all phases of clinical trial execution (Start-up, maintenance, closeout).
Robust experience in oncology and or autoimmune and inflammatory diseases required.
Demonstrated experience with developing clinical operations strategy and plans including site monitoring, risk mitigation plans, recruitment plans, enrollment modeling and CRO/vendor oversight plans.
Experience with managing and demonstrating oversight of CROs, vendors, and consultants.
Experience with managing or mentoring employees directly.
Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials.
Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project/Smartsheet.
Outstanding ability to communicate in an open and clear manner, listening effectively and inviting response and discussion with internal partners and external service providers.
Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
Proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation.
Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority.
Comfortable in a fast paced, results-driven, highly accountable environment with large potential impact.
20% travel required.
Interested Candidates may forward CV and Cover Letter letting us know your area of interest please forward to Careers-US@MonterosaTx.com
Monte Rosa Therapeutics (MRT) is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to identify degradable protein targets and rationally design MGDs with unprecedented selectivity. The QuEEN discovery engine enables access to a wide-ranging and differentiated target space of well-validated biology across multiple therapeutic areas. Monte Rosa has developed the industry’s leading pipeline of MGDs, which spans oncology, autoimmune and inflammatory disease and beyond, and has a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug.
Full Time
$117k-152k (estimate)
07/06/2024
07/19/2024
monterosatx.com
Brighton, MA
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