Trial Physician, Medical Associate Director Director, Respiratory Therapeutic Area
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Job Location:
Bedford, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases we develop and commercialize treatments that address serious unmet medical needs including diabetes pulmonary hypertension pulmonary fibrosis nontuberculous mycobacterial (NTM) lung disease and fluid overload associated with heart failure and chronic kidney disease.
At MannKind our employees are our greatest asset. We foster a close-knit collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds perspectives and working styles as we work together to improve health outcomes and change lives.
Position Summary:
We are currently seeking a highly motivated experienced pharmaceutical industry physician to join our team as a trial physician Respiratory Therapeutic Area. Key responsibility for this position will be to advance the companys respiratory programs with a focus on pulmonary fibrosis.
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 Respiratory Therapeutic Area Head and will play a critical role in the medical and scientific management of programs. This position can sit onsite in Bedford MA or Westlake Village CA.
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 investigators 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 Cardiometabolic therapeutic area if needed.
- Other activities not fully captured in the above based on the organizations needs
Minimum Education & Experience Requirements:
- MD with 3 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 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 field of pulmonary fibrosis or other related pulmonary disorders is a major plus.
- Domestic and international travel (approximately 20%) is required.
Required Experience:
Director
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
