MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.Position Summary:MannKind Corporation is currently seeking an experienced Director, Clinical Operations to lead the design, planning, implementation and execution of clinical study protocols, operational plans and study timelines for MannKind trials, with focus on pulmonary orphan disease. 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 CROs and contractors. This is an exciting opportunity to help build our company narrative and collaborative partnerships with key opinion leaders and investigators.Principal Responsibilities:
Drives Clinical Development activities pertaining to study-level strategy, timelines, quality and execution of clinical studies
Proactively identifies, problem solves and manages risks to trial execution and quality, implements corrective actions, and ensures inspection readiness at all times
Supports 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 guidelines
Drives 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 required
Coordinates the development and distribution of critical study documents (ICFs, operational/training documents, reference documents, newsletters, site materials, etc.) and manages the TMF, as needed
Drives 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 required
Communicates trial status by tracking clinical study metrics to ensure cross-functional alignment on expectations, priorities, and deliverables
Represents MannKind, from a clinical perspective, building strong relationships with clinical trial sites including investigators and study staff
Plans, facilitates, and monitors training at investigator meetings, kick-off meetings, and various CRO/vendor meetings
Demonstrates budget accountability by tracking vendor performance against SOW, contracts and invoices to ensure consistency between work performed and contractual agreements
Partners with Supply Chain to provide oversight and accountability of the applicable study drug(s), including supply projections, distribution, labeling and destruction
Collaborates in the program-level development of clinical strategies, goal-setting, and establishment of timelines
Required Skills and Experience:
BS/BA +11-12 / MS/MBA 8-10
5+ years direct clinical trial experience (phase 2-3 preferred)
Equivalent combination of education and applicable job experience may be considered
Relevant industry (biotech or pharmaceutical) experience
Knowledge of pulmonary orphan diseases and associated medical terminology
Knowledge 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 environment
Exhibits 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 escalation
Ability to organize and manage multiple priorities
Excellent oral and written communication skills
Solution-focused, comfortable with ambiguity, and an organized self-starter
Strong attention to detail in a fast-paced, evolving environment
Works effectively in both individual and team-based settings, with a high sense of urgency
Strong interpersonal skills and ability to build relationships with stakeholders at all levels
