Medical Director - Principal Investigator

Thermo Fisher Scientific • Austin, TX

3d • Onsite

About The Position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our Austin Clinical Research Unit(CRU) focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives. The site also supports some late phase studies and our facility encompasses over 152,000 square feet including on-site laboratories and pharmacies. Late Phase studies also can take place at this facility.

This is a full-time benefit eligible role. Standard day hours(M-F) with a week of call every 8 weeks. On call expectations are light with a couple evening phone calls and minor weekend work.

Discover Impactful Work: The Medical Director conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol, and company processes and ensures the medical well-being and safety of the participants through the safe performance and execution of the studies. The role maintains clinical oversight and quality on the studies registered on and delivers on study targets, thereby contributing to the commercial success of the site which includes: recruitment, enrolment, and retention of study participants.

A day in the Life:
Carries out clinical evaluation and assessment of participants to ensure eligible participants are enrolled in studies. Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety, and retention of participants. Interprets protocols and IB and participates in initiatives to strategize for patient recruitment. Ensures and protects the welfare and safety of participants through ethical conduct; this should receive the highest priority at all times during all aspects of the study. Fulfills and complies with all medical duties as per protocol, SOP/COP, ICH, GCP, and local regulations. Reports any safety threats, that may impact stakeholders/participants and action complaints or QIs as per site processes. Exercises meticulous attention to detail in recording information and source management. Actively involved in audit preparations and site inspections. Oversees the management of investigational medical products (IMP).

Requirements

• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening(where applicable).
• A valid medical degree (M.D. or D.O.)
• A medical license in good standing, with unrestricted ability to practice in place of work, where Applicable.
• Texas State licensure will be required.
• A valid ICH GCP certificate (this can be obtained upon employment)
• No previous experience in clinical research is required but is preferred.
• Must have general medical practitioner diagnosis and treatment proficiency.
• Minimum of 3+ years of leadership, supervisory, or people management experience in a healthcare, clinical, academic, or related environment.
• Demonstrated experience leading multidisciplinary teams, managing performance, and developing talent.
• Good understanding of medical terminology, drug safety, and interpretation of lab reports
• Computer proficiency and confidence in using Microsoft Office and other sponsor-related programs and portals
• Good administration skills and a passion for quality and detail
• Capable of working well under pressure and meeting deadlines
• Good understanding of commercial and financial concepts and the impact thereof on the business
• Capable of consistently working well with others and assisting in other areas as needed
• Capable of learning new processes and systems quickly
• Strong cognitive skills, with the ability to think, read, learn, reason, interpret, and pay attention to detail in daily operations and tasks
• Capable of working independently with good prioritization and multitasking skills

Nice To Haves

• Board Certification in respective field preferred.
• Experience with workforce planning, employee engagement, coaching, and conflict resolution preferred.
• Prior responsibility for operational, quality, or business performance metrics is preferred.
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Responsibilities

• Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol, and company processes.
• Ensures the medical well-being and safety of the participants through the safe performance and execution of the studies.
• Maintains clinical oversight and quality on the studies registered.
• Delivers on study targets, contributing to the commercial success of the site.
• Oversees recruitment, enrolment, and retention of study participants.
• Carries out clinical evaluation and assessment of participants to ensure eligible participants are enrolled in studies.
• Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety, and retention of participants.
• Interprets protocols and IB and participates in initiatives to strategize for patient recruitment.
• Ensures and protects the welfare and safety of participants through ethical conduct.
• Fulfills and complies with all medical duties as per protocol, SOP/COP, ICH, GCP, and local regulations.
• Reports any safety threats that may impact stakeholders/participants.
• Actions complaints or QIs as per site processes.
• Exercises meticulous attention to detail in recording information and source management.
• Actively involved in audit preparations and site inspections.
• Oversees the management of investigational medical products (IMP).

Benefits

• competitive remuneration
• annual incentive plan bonus
• healthcare
• a range of employee benefits
• innovative, forward-thinking organization
• outstanding career and development prospects
• exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Principal