Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Basic Function and Scope of Responsibility:

Transplant Genomics Inc. (“TGI”) is a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by genomics. TGI’s product portfolio of both individual and combined blood gene expression and dd-cfDNA testing is capable of reliably detecting subclinical kidney rejection and acute rejection in kidney transplant patients with stable kidney function, in addition to a new application for liver transplant patients that guides and controls the optimal dose of immunosuppressants.

The Sr. Director, Medical Affairs provides medical and scientific strategic and operational oversight of, clinical trials and medical affairs activities such as: health-care professional and provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines, and value proposition); safeguarding patient safety (risk minimization activities and safety surveillance activities). Provides medical, scientific and technology input to leadership about future product innovations in organ rejection biomarkers, gene expression technologies (arrays, sequencing, qPCR etc.) or digital technologies (Cloud, AI/ML, bioinformatics, EMR etc.). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical and marketing activities (promotional material generation and product launches) and market access.. A successful candidate in this role can expect increasing responsibility within Medical Affairs or Innovation at TGI commensurate with individual contribution and company performance.

Essential Job Duties:

• Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE's & SAE's) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
• Provides medical, scientific and technology leadership to future product innovations in organ rejection biomarkers, gene expression technologies (arrays, sequencing, qPCR etc.) or digital technologies (Cloud, AI/ML, bioinformatics, EMR etc.)
• May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, laboratory operations, research and development, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
• May provide scientific/medical education to investigators, Clinical Research Organization partners, and internal team members related to therapeutic area or disease specific information.
• Keeps abreast of medical, scientific and technology innovations through conferences and/or peer-reviewed literature.
• Responsible for understanding the regulatory requirements related to the clinical studies and medical device/in vitro diagnostic development and accountable for complying with those requirements.
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
• Can address complex problems within discipline/project or across disciplines. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors.
• Take part in management of scientific and clinical advisory boards.
• Support company initiatives at clinical and scientific meetings.

Essential; Experience, Knowledge, Skills and Abilities:

• Doctorate degree (MD, PhD, DO or PharmD) required.
• More than 6 years advanced medical/scientific knowledge within clinical, pharmaceutical, medical or diagnostic industries, with preference given to those with experience in solid organ transplantation.
• Experience managing Clinical Trials, writing scientific publications, setting and adhering to
• departmental budgets.
• Willing and able to travel up to 50%.
• Ability to understand and effectively compare and contrast diagnostic technologies used at Transplant Genomics against other available technologies
• Ability to understand and effectively discuss treatment and care of kidney and liver transplant patients, immunosuppression management, kidney or liver transplant rejection, and related areas of Transplant Genomics' services 
• Ability to monitor and understand latest information from clinical studies and abstracts
• Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization
• Ability to keep sensitive information confidential
• High level of proficiency with PC based software programs

Physical Requirements:

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting
• Ability to continuously operate a personal computer for extended periods of time (4 or more hours)
• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions
• Must be vaccinated against the novel COVID-19 virus variants or provide proof of approved exemption.

All your information will be kept confidential according to EEO guidelines. 

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.