Pharmaceutical Medical Director

Position Summary

We are currently seeking a highly motivated, experienced pharmaceutical industry physician to join our Clinical Development Team as a Medical Director. This physician's primary responsibility will be to advance the company's orphan lung programs in NTM, IPF, CF and related pulmonary disorders.

The primary responsibilities of this position are to plan, design, and conduct our early development clinical studies; the preparation of regulatory documents to file IND 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 subject enrollment, the use of statistics, assessment of endpoints, and operational execution. This position works both independently and collaborates with study and project teams, senior management, and outside advisors and vendors.

In addition, this physician will help advance early-stage compounds into the clinic. This position will report to the SVP of Clinical Development & Medical Affairs and will play a critical role in the medical and scientific management of programs.

Key Responsibilities:

• Study Planning:
• Assist with the strategic planning and execution (including study design, method selection, etc) of Phase I through IV global 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 subject eligibility criteria for study participation and selecting clinical and mechanistic endpoints to demonstrate drug activity.
• Demonstrate understanding and the ability to utilize corollary tools such as mathematical models to evalute the study data. Act as clinical study leader.

• Study Execution: Collaborates with:
• Biostatistics / Data Management for statistical support and data capturing;
• Safety and Pharmacovigilance for safety endpoint definition and adverse events reporting;
• Translational Medicine and Clinical Pharmacology for determination of biomarker and pharmacokinetic endpoints;
• Clinical Operations to select and establish effective communication with external vendors and to contribute to the logistical conduct of studies;
• Regulatory Affairs to align studies with local, national and international health authority requirements;
• Quality Assurance to guarantee health information privacy and data integrity.
• Additional Study-Related Activities:
• Contributes to the preparation of regulatory documents for IND filing (e.g., IND modules and ICF), 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 (MDs only).
• 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 by evaluating in-licensing opportunities (e.g., conducting due diligence) and preparing assets for out-licensing.

Minimum Education & Experience Requirements:

• MD or MD/Ph.D. with at least 10 years of pharmaceutical drug development experience. Additional experience as a research scientist in academia or other settings is a plus.
• Demonstrated expertise in Pulmonary Disorders

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 (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.
• Domestic and international travel (approximately 20%) is required.

SKILLS AND CERTIFICATIONS
MD/Ph.D. with at least 10 years of pharmaceutical drug development experience
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.