Director, Drug Safety & Clinical Development

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:

MannKind Corporation is seeking an experienced and strategic Director of Drug Safety & Clinical Development to support end-to-end clinical programs from Phase 1 through Phase 4, with a strong emphasis on pharmacovigilance, early development strategy, and cross-functional collaboration. This highly visible role is integral to advancing our pipeline across different business units, ensuring patient safety and reporting, and maintaining compliance with global regulatory requirements. The role will also serve as a scientific partner in protocol development, clinical trial governance, and KOL engagement strategy.

Principal Responsibilities:

Clinical Development Strategy:

Support the design and execution of Phase 1-4 clinical trials, including development of protocols, study amendments, safety sections of IBs, ICFs, and other safety-related documents, and oversight of safety components in operational plans.

Drug Safety Leadership:

Oversee safety monitoring activities across the portfolio, including adverse event reporting strategies, signal detection, risk management, and the development of Safety Monitoring Plans (SMPs) and Safety Review Committee (SRC) Charters.

Oversee safety vendors and safety related activities.

Cross-functional Collaboration:

Serve as the clinical safety liaison across Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Biostatistics, Medical Affairs, and external partners to drive study execution and maintain safety standards.

KOL and Advisory Engagement:

Partner with KOLs and scientific advisory boards to inform protocol design, dose selection, and endpoint strategy, incorporating external insights into clinical and safety development plans.

Regulatory Support:

Prepare and review global regulatory submissions (e.g., INDs, CTAs, DSURs, REMS, BLAs/sBLAs, and NDAs), including responses to Health Authorities' safety queries. Contribute to the safety narrative and strategy in briefing documents and Health Authority interactions.

Data Review and Interpretation:

Lead or support ongoing data reviews for safety signals and trends. Work closely with clinical scientists, study leads, data management, and biostatistics to interpret study data and develop interim and final study reports.

Publication & Scientific Communication:

Support the preparation of publications, posters, and scientific presentations based on clinical trial data to share findings with the broader medical community.

Process Optimization and Compliance:

Ensure compliance with GCP, ICH, and global pharmacovigilance regulations. Propose and implement process improvements to optimize clinical safety operations.

Qualifications:

• PharmD, MD, or PhD in a life sciences discipline required.
• 10-15+ years of industry experience in drug safety, clinical science, or clinical development, with increasing responsibility.
• Proven experience supporting early- and late-phase clinical trials (Phases 1-4).
• Strong background in pharmacovigilance and safety governance, including signal detection and aggregate safety reporting.
• Experience in setting up a pharmacovigilance infrastructure in small / medium biotech companies.
• Demonstrated experience collaborating with KOLs and external advisors to shape development strategy.
• Experience leading or supporting regulatory submissions (e.g., NDA, MAA) and health authority interactions.
• Excellent project management, cross-functional leadership, and communication skills.
• Experience in rare disease or metabolic/diabetes indications is a plus.

Knowledge/Skills Needed:

• Excellent verbal, interpersonal and written communication skills, a strong scientific background with industry drug pharmacovigilance, clinical development experience, creativity, and flexibility
• Strong team leadership skills are required.
• Ability to work in a team environment with both internal and external members.
• Experience in clinical trial design
• Familiarity with thought leaders in the fields of NTM, IPF, and/or related pulmonary disorders is a plus.
• Domestic and international travel (approximately 10-15%) may be required.

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 [click to reveal email address] [email protected] .

Pay Range: $176,000 - $264,000 per year