ParallelDesk
Login

Senior Vice President, Developmental Operations

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer, infectious diseases, and autoimmune and inflammatory diseases. IgM antibodies have inherent properties that we believe may enable them to bind more strongly to targets on the surface of cells than comparable IgG antibodies. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. Our lead product candidate, Imvotamab, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins, and it is currently in two Phase 2 clinical trials for the treatment of relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with relapsed and/or refractory solid and hematologic malignancies, and it is currently in a Phase 1 clinical trial. Also in our product pipeline is IGM-7354 and IGM-2644. IGM-7354 is an anti-PD-L1 IgM antibody that targets the delivery of interleukin-15 (IL-15) cytokines to the area of PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies. IGM-2644 is a bispecific T cell engaging IgM antibody targeting CD38 and CD3 proteins for the treatment of patients with multiple myeloma.Currently in the field of oncology, IGM has clinical stage programs for the treatment of solid and hematological malignancies, and IGM is also developing high affinity, high avidity IgM antibodies for the prevention and treatment of patients with autoimmune and inflammatory disease.The SVP Developmental Operations is an executive leader responsible for strategic planning, oversight, and execution of clinical trial operations for all IGM clinical programs across all therapeutic areas including Oncology, Autoimmunity, and Infectious Disease. This requires the accurate projection and ownership of timelines, quality expectations, budgets and related deliverables and the ability to interface effectively with key internal and external stakeholders, including strategic partners and Contract Research Organizations (CROs). This position reports to the Chief Medical Officer and is responsible for operational activities across all IGM’s therapeutic areas including oncology, autoimmunity/immunology, and infectious diseases. The SVP of Developmental Operations is an integral member of the Clinical R&D Leadership team and IGM’s Senior Staff.Qualifications:· Bachelor's degree in a scientific discipline, advanced or professional degree desirable· 18+ years of pharmaceutical industry experience including experience at the executive/VP level leadership, and a consistent track record in clinical drug development with complex clinical studies including leading global trials in an outsourced CRO partnership model· Strong executive leadership skills with ability to build, lead, manage, and justify resources for clinical operations and other clinical support departments capable of supporting multiple, concurrent clinical trials across different therapeutic areas including oncology, autoimmunity, and infectious diseases· Successful track record in managing early phase and late-stage global clinical trials; experience in leading pivotal studies and involvement in regulatory filing is a plus· Demonstrated capability for accurately projecting clinical timelines, budgets, and deliverables· History of success in negotiating with and managing clinical service vendors· Proven ability to collaborate with other members of senior management and cross functional leadership in a transparent and productive manner· Experience in building and managing a dedicated, cohesive, and engaged operations team· Ability to institute a solutions-oriented problem-solving approach with the ability to push timetables while keeping teams motivated· Proven ability to strategically allocate clinical development resources based on program priority, complexity, and risk· Demonstrated strategic flexibility and ability to manage effectively during times of uncertainty and/or changes in corporate priorities· Experience in establishing critical tools and infrastructure related to Clinical Operations including but not limited to cGCP quality systems, SOPs, and standardized internal workstreams and program tracking tools· Provides deliverables that meet the highest industry standards with regards to quality and compliance· Possess a thorough knowledge of the clinical development process and FDA, EMA, and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelinesResponsibilitites:· Oversees and leads the operations teams to ensure that trial deliverables across programs are completed according to timelines, prioritization, budgets, quality standards, SOPs, and clinical/business guidelines. This position has the potential to lead other clinical departments depending on past experience· Contributes to broader development strategy discussions and helps enable informed decision making by highlighting operational implications, risks, and trade-offs for strategic options under consideration· Sets developmental operations strategy and performance standards to assure that project objectives are achieved with the resulting output of reliable, credible clinical datasets that are ready for inspection by regulatory authorities· Identify and justify resource needs for implementation of operational plans and partners with Clinical Program Management to incorporate and update clinical timelines and budgets into overall product development plans· Builds a scalable and flexible Developmental Operations infrastructure that can meet portfolio and organizational needs for current and future programs· Delegates responsibility and empowers others, and ensures that staff are qualified, competent, and trained in applicable regulations, guidance and IGM standards· Provides executive oversight and effectively manages relationships with CROs and vendor partners, establishes vendor metrics, and conducts regular management reviews to maintain the quality of vendor output· Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion· Develop and manage clinical trial budgets and proactively provides senior management with necessary updates on progress and changes in scope, schedule, and resources· Develops IGM operations staff by identifying and mentoring high performers and building a culture of inclusion and collaboration throughout the organization· Seeks opportunities to make IGM a partner of choice for investigators, KOLs, and sites· Ensures compliance with quality standards, SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards in the conduct of clinical trials· Ensures inspection readiness of both active and completed clinical trials· Works closely with cross-functional Clinical R&D leadership across therapeutic areas including Clinical Development, Biostatistics/Stats programing, Clinical Data Management, Clinical Supply Chain, Regulatory Affairs, Quality Assurance, Pharmacovigilance/Safety, Clinical Pharmacology, Clinical Biomarkers, and Clinical Program Management\n\nOne of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we are offering robust and comprehensive benefits with a variety of options:· Medical, dental, and vision insurance. The full premium amount for our employees and their dependents is currently covered by IGM· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance· 401(k) Plan· 120 hours of Paid Time Off, 5 sick days per year, 10 holidays· Cell phone & internet subsidy· Employee Referral Bonus Program· Annual training budget for professional development· Commuter Benefit· Annual bonus program· New hire stock options IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

Job Type
Full Time
Salary
N/A
Experience
N/A
Posted
17 days ago

Similar Jobs from Partners

More Jobs

Physician / Radiology / California / Locum tenens / Diagnostic Radiology Physician Job

Staff Care / Visalia
10 hours ago

Apply

Physician / Anesthesiology / Mississippi / Locum tenens / (Anesthesiology) Locum Tenens Job

Staff Care / Flowood
10 hours ago

Apply

Manager Registered Nurse (RN) - Telemetry PCU - Progressive Care Unit - $120K-140K per year

Core Medical / Concord
17 days ago

Apply

Registered Nurse (RN) - Home Health - $60K-100K per year

Core Medical / West Bridgewater
17 days ago

Apply

Registered Nurse (RN) - Labor and Delivery - $35-70 per hour

Core Medical / Boston
17 days ago

Apply

ParallelDesk News

Stellenmarkt des Kölner Studierendenwerks - Deine Stadt. Dein Job.

Srini | 21 December 2022

How do I make an HTTP request in Javascript?

Paralleldesk | 20 December 2022

Remote Jobs a Brief

Srini | 19 December 2022

US Green Card Immigration

Srini | 19 December 2022

Covid Conspiracy

Srini | 19 December 2022