About MannKind
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. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more.
Position summary:
We are currently seeking a highly motivated, experienced Microbiologist to join our Inhalation Research Team in Boston, MA. Key responsibility for this position will be to advance the company's orphan lung programs in nontuberculous mycobacterial (NTM) lung disease, and other infectious target adjacencies and to oversee the execution of the microbiology data collection in the currently ongoing phase-3 ICoN-1 trial. Additional responsibilities may include to plan, execute, and summarize microbiology studies on new drug substances. The focus will be primarily clinical studies (e.g., clinical development and sampling/analysis in clinical studies), as well as preclinical models. This individual will understand and set the preclinical strategy for inhaled studies at our partner Clinical Research Organizations (CROs). Previous exposure to FDA pulmonary or anti-infective programs would be a major plus. Pharmacokinetics experience would also be a plus. In collaboration with contract labs, will perform advisory functions in dealing with items found to involve microbial and antibiotics material; and completes and/or reviews microbiology section of investigational new drugs (IND's) and new drug applications (NDA's).
Principal Responsibilities:
- Design, oversee and publish out-sourced and/ or collaborative studies for inhaled drug programs
- Monitor and QC data quality and ensure appropriate data dissemination through a database
- Communicate results of these important studies, and the impact of the data, clearly and effectively at both internal and external meetings
- Draft and contribute to microbiology sections of regulatory filings
- Support all microbiology-related business development (in-bound and outbound activities)
- Effectively resolve any scientific and technical challenges using knowledge and subject matter expertise
- Provide scientific insights on microbiology aspects to support progression of MannKind's pulmonary or anti-infective programs
- Routine analysis of samples using analytical procedures
- Must be able to obtain traceable, reproducible, and reliable results with limited supervision
- Scientific writing for reporting, data management reporting, and ability to follow standard operating procedures is a must
- Routine and non-routine equipment maintenance of instruments and workspaces
- Domestic travel may be required especially to the company's other campuses, but it is not expected to be > 10%
- Experience with GCP and clinical trials is required
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 equivalent scientific training in microbiology
- Experience with pulmonary pathogens and diseases preferred
- Scientific excellence, to include at least 8+ 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
- Ability to work in a team environment with both internal and external (e.g., CRO) members.
- Experience working with study investigators and staff at clinical sites
- Experience in clinical trial design specific to pulmonary disorders
- Solution-focused, comfortable with ambiguity, and an organized self-starter
- Strong attention to detail in a fast-paced, evolving environment
- Strong team leadership skills are required. Works effectively in both individual and team-based settings, with a high sense of urgency
- Excellent verbal, interpersonal and written communication skills, a strong scientific background with industry drug development experience, creativity, flexibility. 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 and clinical trials and literature to project teams and at management reviews
- Regulatory experience and interactions are a major plus
- PK experience and understanding is also a plus
Equal Employment Opportunity (EEO)
MannKind values diversity and is firmly committed to providing equal opportunity and a positive working environment in all aspects of employment. It is the policy of MannKind to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Additionally, MannKind prohibits discrimination based on race, color, religion, national origin, sexual orientation, sex, age, disability or any other legally prohibited basis. This applies to all employment practices, including recruiting, hiring, pay, performance reviews, training and development, promotions, and other terms and conditions of employment. MannKind makes hiring decisions based solely on qualifications, merit, and business needs at the time. If you require an accommodation to complete the application or interview process, please contact recruiting@mannkindcorp.com.
|
Mannkind Corporation
Jan 12, 2025 