Trial Physician, Medical Director, Orphan Lung Programs - MannKind

At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

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 pharmaceutical industry physician to join our team as a trial physician, orphan Lung / Pulmonary Programs. Key responsibility for this position will be to advance the company’s orphan lung programs in nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and other target adjacencies. 

The primary responsibilities of this position are to plan, design, and conduct our development clinical studies; the preparation of regulatory documents to file IND, NDA, and study reports; and to represent the clinical development function on study and project teams. This position requires a comprehensive understanding of clinical research for drug development, from hypothesis formulation to participants enrollment, the use of statistics, assessment of endpoints, CRO management, and operational execution. This position works both independently and collaborates with study and project teams, cross-functional partners, senior management, outside advisors and vendors, and sites personnel.

In addition, this physician will help advance early-stage compounds into the clinic.  This position will report to the SVP, Therapeutic Area Head, Orphan Lung Programs and will play a critical role in the medical and scientific management of programs.

Key Responsibilities:

• Study Execution in a GCP compliant way
  • Be accountable for study recruitment
  • Ensuring highest quality of data generation and collection
  • Ensuring study activities are GCP compliant
  • Medical monitoring
  • CRO Management
  • Collaborate with Biostatistics / Data Management for statistical support and data capturing.
  • Oversee safety oversight activities across different programs and trials
  • Safety and Pharmacovigilance for adverse events assessments and reporting.
  • Contribute to the logistical conduct of studies in very close collaboration with Clinical Operations to select and establish effective communication with external vendors.
  • Collaborate with Regulatory Affairs to align studies with local, national and international health authority requirements.
  • Quality Assurance to guarantee health information privacy and data integrity.

• Study Planning:
  • Assist with the strategic planning and execution (including study design, method selection, etc…) of Phase 1 through 4 clinical trials.
  • Review literature and consult with internal experts and external advisors and advisory boards, contributing to identifying these experts and assembling these boards.
  • Delineate participants eligibility criteria for study participation and selecting clinical endpoints.
  • Demonstrate understanding and the ability to utilize corollary tools such as mathematical models to evaluate the study data. Act as clinical study lead for assigned study(ies).

• Additional Study-Related Activities:
  • Contributes to the preparation of regulatory documents for IND filing (e.g., IND modules and ICF), NDA, and collaborating with preclinical research functions (e.g., Pharmacology and Toxicology).
  • Prepares and presents material for first-in-human committees; prepares study reports, collaborating with Medical Writing.
  • Responsible for or contributes to (in conjunction with a CRO medical monitor) study medical monitoring.
  • Analyze and interpret data and clearly communicate results both internally and externally.
  • Contribute to and review clinical documents (slide presentations, protocols, clinical study reports, regulatory submission sections, investigator’s brochures, etc.)
  • Work collaboratively with other Medical Directors, and colleagues in Biostatistics, Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs.
  • Work closely with Contract Research Organizations, Principal Investigators, Advisory Boards, key opinion leaders, and US and global regulators.

• Additional Activities:
  • Represents Clinical Development on study and project teams and may also act as project team leader.
  • presents to senior management.
  • supports business development activities (e.g., conducting due diligence).
  • Supporting the clinical, medical and safety activities in the endocrinology therapeutic area, if needed.
  • Other activities not fully captured in the above, based on the organization’s needs

Minimum Education & Experience Requirements:

• MD with 6+ years of experience in pharmaceutical drug development.
• Strong preference for pulmonologists
• Demonstrated expertise in Pulmonary Disorders or trials is a major plus

Knowledge/Skills Needed:

• Excellent verbal, interpersonal and written communication skills, a strong scientific background with industry drug development experience, creativity, and flexibility.
• Strong team leadership skills are required.
• 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.
• Familiarity with thought leaders in the fields of NTM, IPF, CF and/or related pulmonary disorders is a major plus.
• Domestic and international travel (approximately 20%) is 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 recruiting@mannkindcorp.com.