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 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 +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 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
- Willingness to travel up to 25% of the time
