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

Danbury, Connecticut, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

222000.0

Posted On

13 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Protocol Design, GCP, FDA Regulations, CRO Oversight, TMF Management, Budget Accountability, Study Start-up, Risk Management, Clinical Monitoring, Vendor Management, Cross-functional Collaboration, Subject Enrollment, Clinical Study Reports, Pulmonary Orphan Diseases, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description

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 trail 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 Trail 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 #LI- Remote #LI-Onsite

Responsibilities

Lead the design, planning, and execution of global clinical study protocols and operational plans. Coordinate study execution in collaboration with internal teams, CROs, and external vendors while ensuring regulatory compliance.