Trial Physician, Medical Director, Orphan Lung Programs
hace 3 meses
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 GCO compliant wayBe accountable for study recruitmentEnsuring highest quality of data generation and collectionEnsuring study activities are GCP compliantMedical monitoringCRO ManagementCollaborate 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: Bachelor's Degree (BS) with 18+ years; Master's Degree (MS) with 16+ years or Doctorate (MD/PhD) with 18+ years of experience in pharmaceutical drug development.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, 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.
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