Senior Director, Medical Affairs and Innovation

Company Description

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 agroscience Contract Research Organization 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 Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 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 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

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 medi