Associate Director, Trial Lead Clinical Operations (Contract to Perm)

Position: Associate Director, Trial Lead Clinical Operations (Contract to Perm) Location: Westlake Village, CAJob Id: 112945 # of Openings: 1 MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. The company applies deep expertise in formulation science and inhalation‑device engineering to reduce the treatment burden for conditions such as diabetes, congestive heart failure, pulmonary fibrosis, and pulmonary hypertension. MannKind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, MannKind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases. At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.Position Summary:MannKind Corporation is currently seeking an experienced global trial lead, Clinical Operations to lead/support the design, planning, implementation and execution of clinical study protocols, operational plans and study timelines for MannKind trials, The role will manage all aspects of study progress, including protocol design, development and planning, study initiation, execution and close-out, and support for the development of clinical study reports, abstracts for professional meetings and publications. The role will ensure adherence to all appropriate regulatory guidelines as well as support the development and implementation of clinical processes, procedures and programs. Lastly, the role will ensure that project/department milestones and goals are met, adhering to approved budgets. Key part of this role is to coordinate the study execution in collaboration with internal team, CROs and contractors. This is an exciting opportunity to help build our company narrative and collaborative partnerships with key opinion leaders and investigators. This position is Temp to Hire.Principal Responsibilities:Drives global Clinical Trial activities pertaining to study-level strategy, timelines, quality and execution of clinical studiesProactively identifies, problem solves and manages risks to trial execution and quality, implements corrective actions, and ensures inspection readiness at all timesSupports the development of clinical study protocols and reports, ensuring studies are conducted in accordance with accepted scientific standards, meet relevant regulatory requirements and are conducted within ethical guidelinesDrives development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc.Ensure adherence to FDA and GCP guidelines as well as other appropriate regulatory bodies as requiredCoordinates the development and distribution of critical study documents (ICFs, operational/training documents, reference documents, newsletters, site materials, etc.) and manages the TMF, as neededDrives study start-up, subject enrollment plan, clinical monitoring activities, clinical site compliance and data metrics from CROs and/or investigators, central labs, and other external vendors as requiredCommunicates trial status by tracking clinical study metrics to ensure cross-functional alignment on expectations, priorities, and deliverablesRepresents MannKind, from a clinical perspective, building strong relationships with clinical trial sites including investigators and study staffPlans, facilitates, and monitors training at investigator meetings, kick-off meetings, and various CRO/vendor meetingsDemonstrates budget accountability by tracking vendor performance against SOW, contracts and invoices to ensure consistency between work performed and contractual agreementsPartners with Supply Chain to provide oversight and accountability of the applicable study drug(s), including supply projections, distribution, labeling and destructionCollaborates in the program-level development of clinical strategies, goal-setting, and establishment of timelinesRequired Skills and Experience:BS/BA +12 / MS/MBA 8-10, PhD 5+5+ years direct clinical trial global experience (phase 2-3 preferred)Equivalent combination of education and applicable job experience may be consideredRelevant industry (biotech or pharmaceutical) experienceKnowledge of pulmonary orphan diseases and associated medical terminologyKnowledge of Good Clinical Practices (GCP) and associated FDA regulations governing human subject protection and the conduct of clinical trial (IRB, IND, etc.)Proven experience in the oversight of the operational aspects of clinical studies, preferably in a global environmentExhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalationAbility to organize and manage multiple prioritiesExcellent oral and written communication skillsSolution-focused, comfortable with ambiguity, and an organized self-starterStrong attention to detail in a fast-paced, evolving environmentWorks effectively in both individual and team-based settings, with a high sense of urgencyStrong interpersonal skills and ability to build relationships with stakeholders at all levelsWillingness to travel up to 25% of the time#LI- Remote#LI-OnsitePay Range: $148,000 - $222,000 per year