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Therapeutic Area Lead (Executive Director / Vice President)

Mannkind

This is a Contract position in Danbury, CT posted June 1, 2022.

Position summary:

MannKind Corporation currently has an open position for an R&D Therapeutic Area Lead (TAL) who will be responsible for our pre-clinical and clinical development programs in PAH and ILD. The primary responsibility will be the development and implementation of the safety and risk management strategy within the therapeutic area projects through Phase 1 and towards Phase 2, ensuring the strategy is aligned with the overall objectives of the TA, and enabling those TA goals to be met. In addition, as a member of TA-specific governance bodies, the TAL is expected to fully engage such that they contribute expertise to all aspects of programs within the TA. The TAL ensures provision of expertise within TA for assessment of potential, including where necessary, identification of resources to participate on due-diligence teams. Through a matrix or reporting relationship, the TAL will provide ongoing guidance and mentorship to the team leads through Phase 1 and towards Phase 2. Through active external surveillance, consultation with external key opinion leaders, and collaboration with internal subject matter experts, the TAL drives organizational and regulatory acceptance of innovative scientific approaches, biomarker strategies and regulatory packages to accelerate program and portfolio deliverables. This role will bring unique subject matter expertise to deliver disproportionate value to management and resolution of portfolio issues. In close collaboration with Research leaders and other partner lines, the TAL will play an important role to accelerate identification of new targets, inhaled drug targets for orphan disease, and novel molecules to build the Research pipeline.

Principal Responsibilities:

  • Perform all regulatory responsibilities in compliance with applicable regulatory standards
  • Management of Drug Safety Team and Phase 1 team for the ILD and PAH portfolio such as Portfolio Liaisons, Licensing and Acquisition leads. These may be direct reports or matrix management relationships.
  • Drives organizational and regulatory acceptance of innovative scientific approaches, biomarker strategies and regulatory packages to accelerateportfolio deliverables in close collaboration with the Research, Regulatory, and Clinical Operations.
  • Assures that expedited packages are achieved through active external surveillance, consultation with external key opinion leaders, and collaboration with internal subject matter experts.
  • As the early and Phase 1 development representative to the CSO and Development Review Committee, provides strategic direction, scientific expertise, and resource prioritization and is accountable for delivery of the Drug Safety component of the TA through Phase 1 and towards Phase 2.
  • Point of accountability for the development and delivery of comprehensive programmatic development strategies to ensure rapid progression through Research and Development.
  • Oversees development and approve implementation of biomarker and risk management strategies developed by Team Leads to ensure progression of compounds and programs within TA.
  • Ensures that the development strategy specific to that TA is aligned with Program objectives and priorities.
  • Responsible for within ILD prioritization of projects and/or project related activities, to guide resourcing decisions within R&D
  • Planning and leading advisory board meetings in the therapeutic area
  • Oversees the review and approval of toxicology plans and endorse any needed exceptions to standard protocols.
  • Reviews and endorses components of stage gate documentation, including CAN documents, Nonclinical Overviews (NCOs), Investigator Brochures (IBs), etc through global registration.
  • Ensures that study reports and regulatory submission documents are consistent in their interpretation and are aligned with risk management strategies.
  • Review and endorsement of regulatory responses and participation in Regulatory Agency interactions, as required.
  • Final approval of the use of within-TA compounds in studies which employ toxicologically relevant doses and/or are intended to assess safety.

Required Skills and Experience:

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

  • Ph.D., and/or MD
  • Scientific excellence, to include at least 10+ years of experience in basic and applied research and development preferably in pharma and/or mid-size/large biotech; solid scientific track record, exemplified by publications, and overall stature in the field of pharmaceutical R&D
  • Prior extensive experience in design and interpretation of safety evaluation studies; first-hand experience spanning all stages of drug development including Registration; experience as a clinical lead or issues management lead are desirable
  • Documented success in partnering with other senior leaders to ensure alignment of issue resolution strategies across companies
  • Makes good scientific and regulatory decisions based on a mixture of analysis, wisdom, experience, and judgment. Can make high quality decisions in an ambiguous environment, e.g., without access to all data that might be desired
  • First-hand experience in non-clinical safety and clinical development of pulmonary/inhaled in preclinical and clinical stages of development
  • Recognized externally as a thought leader in safety/clinical assessment of novel modalities (publications or as a member of external consortia)
  • 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

  • Must be able to effectively organize, report and communicate results from experiments to project teams and at management reviews. #LI-Remote

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)