The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking an Executive Director, Trial Physician, Medical Director, Orphan Lung Programs in Paramus, NJ.

Role Description

• 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.

Skills & Requirements

• 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.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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