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Job Details

Requisition Number 18-0028
Post Date 4/21/2018
Title Director - Clinical Program Management
City Westlake Village
State CA
Description

MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) inhalation powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

Position Summary:

MannKind is seeking a Director, Clinical Program Management (CPM) who will be responsible for leading internal (Clinical Development) and/or external (Strategic Partner/Vendor Contractors) cross-functional resources to ensure that overall study timeline, scope, cost and quality goals are met. The CPM is an expert on the cross-functional delivery of clinical trials and brings that expertise to the design and conduct of clinical development.  The CPM helps to drive study planning discussions that balance scientific, regulatory, operational, and strategic considerations for a project to meet business needs.  

Principal responsibilities:

The CPM is accountable for the operational delivery of one or more clinical studies from study concept through reporting, submission and regulatory defense within one or more development projects. The CPM is responsible for operational oversight of all study activities and escalates issues when needed. The CPM also provides technical contributions to protocols and other documents as appropriate.   The CPM provides joint leadership, in partnership with the Clinician of the study team, and ensures good team functioning.

The major duties and responsibilities will include but are not limited to:

  • Study Team Leadership
    • Serves as co-lead (with Clinician) of study team and leads the Clinical Operations sub-team.
    • Ensures cross-functional connectivity among team members and supporting functional lines 
    • Manages study team meetings and facilitates effective decision making
    • Fosters synergistic team health and engagement.
  • Practical Clinical Trial Design
    • Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design.
    • Initiates and ensures a feasibility assessment is performed by seeking input from other lines within Clinical Development - at the Strategic Partner/Vendor as needed. 
  • Clinical Planning
    • Partners with medical, medical affairs, regulatory, CMC, and marketing to help develop clinical plans for new assets (Phase 2, 3) or existing products (Phase 4) to meet business goals.
    • Ensures linkage with regulatory, procurement, finance, and CMC on program status such that appropriate plans are in place within these functions to support the clinical programs.
  • Clinical Development
    • Partners with medical, statistics, regulatory and other functions to develop study protocols.
    • Key contributor to and reviewer of clinical study reports, clinical regulatory documents for submissions, and scientific disclosures.
  • Clinical Study Operational Oversight
    • Accountable for the cross-functional operational success of the study.
    • Serves as primary Clinical Development point of contact for the study. Engages early within project team to ensure effective up-front planning inclusive of regulatory and competitive landscape.
    • Develops accurate study plans (timelines, budget), with vendors as appropriate, and creates metrics as needed to monitor study performance to plan.
    • Partner/Outsourcing Provider and utilizing resources from Clinical Development and aligning with business needs.
    • Provides critical assessment of Strategic Partners and 3rd party vendor proposals.
    • Oversees project feasibility and subsequent functional feasibility in partnership with internal departments and Strategic Partner/Vendor to ensure clarity of timelines.
    • Maintains collaborative working relationship with CRO to provide appropriate level of SP/vendor oversight to ensure study success. Assists in issue resolution and escalation when needed. 
    • Ensures and enhances investigator/site relationships.
    • Works proactively with CRO/ internal functions to ensure timely study data and reports. 
  • Quality/Risk Management Activities
    • Lead the proactive identification of risks to delivery or quality and ensures that appropriate cross-functional risk mitigation plans are in place.
    • Communicates opportunities and risks to the Clinical Development project leadership.
    • Ensures compliance with all applicable SOPs and Quality Standards
    • Coordinates and oversees inspection readiness activities including maintenance of study documentation.
  • Financial Oversight
    • Forecasts and manages clinical program budget.
    • Keen understanding of vendor contract(s), pass-through and direct expenses.
    • Ensures project scope is aligned with budget throughout duration of project.
    • Proactively monitors budget and reviews invoices, as needed, to ensure vendor billing is appropriate given the project status.
  • Clinical Development Lead for Regulatory Submissions
    • Provides oversight of clinical deliverables associated with regulatory submissions and partners with regulatory function to ensure integrated submission plans to meet business needs. 

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

Requirements

Education and Experience Qualifications:

Training & Education Preferred:

  • BS/BA Degree with 15+ years of experience and/or MS with 12+ years of experience
  • Preferably a minimum of 10+ years of industry experience within clinical research/operations and a strong knowledge of Clinical Development; Project Management; and Vendor and Contract Management including managing CRO staff to deliver clinical studies.
  • Ideal: 5+ years in Diabetes drug development inclusive of study design, conduct, analysis, and disclosure.

Technical Competencies:

  • Effective cross-functional leadership and demonstrated ability to influence, negotiate, and problem solve in a cross-functional setting.
  • Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines and basic understanding of the phases of clinical development is required. Familiarity with the drug approval process through NDA is required.
  • Thorough understanding of key operational elements of clinical research (e.g., study design and feasibility, site selection, monitoring, data acquisition and cleaning, reporting and statistics, study report writing).
  • Ability to contribute to protocol design and data interpretation, and subsequent development and review of study reports and other disclosures from completed studies. 
  • Ability to participate and support sponsor regulatory interactions/inspections 
  • Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a good knowledge of regulations and guidelines.  Understanding of scope management, critical path identification and timeline mitigation, risk management and contingency planning, and financial management.
  • Demonstrated ability to communicate clearly and succinctly with team members and leadership.
  • Partner effectively with Vendors to delivers projects on time and budget.
  • Strong coaching/mentoring and networking/relationship building skills.
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