At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Senior Medical Director, Scientific Affairs

Gaithersburg, MD

Your role:

To achieve the goal of providing highly differentiated medicines to patients, you will have the exciting opportunity to play a leadership, hands-on role within the functional area of T cell immunotherapy and Hematopoietic Stem Cell Transplantation (HSCT). The candidate will be the Early Clinical Development Mission Team leader driving assessment of various CAR-T, TCR-T assets, and graft engineering for Hematological and Non-Hematological Malignancies.

More specifically, you will lead the program that oversees phase 1 studies conducted through the Investigator-initiated trial (IIT) model to develop various CAR-T, TCR-T assets, and HSCT from matched and mismatched donors. Furthermore, the role interfaces with the research and clinical leaders of Miltenyi Biotec R&D and Miltenyi Biomedicine to address critical issues, bring relevant ideas and identify unmet needs from a clinical perspective for renewed discovery efforts. The roles and responsibilities also provide international exposure through interactions with our global clinical and research teams at Miltenyi Biotec and Miltenyi Biomedicine and collaborators across the globe. The unique responsibility allows you to become a subject matter expert in novel technologies in cell and gene therapy and make valuable contributions to developing cutting-edge immunotherapy products to benefit human health.

Responsibilities:

• Assist the Medical Affairs Governance in the USA with a team of 4-5 members
• Champions Medical Excellence and Strategy Governance
  • Works closely with the global medical teams to contribute with a high standard of scientific knowledge
  • Oversight of the development, prioritization and delivery of the local Medical Affairs Plans that address identified gaps
  • Anticipates and identifies areas of strategic interest within the country care management system and addresses those through the medical component of the local business unit/ Medical Affairs Plan and key medical deliverables
• Ensuring a seamless Phase l development plan for CAR-T, TCR-T assets, and HSCT engineering approaches starting from candidate selection onwards, having the ultimate goal of regulatory approval, launch, and life cycle management in mind
• Building and developing relationships with key internal stakeholders including R&D, regulatory affairs, legal, late-stage development team from Miltenyi Biomedicine, commercial, supply, and technology operations to advance phase 1 trial of immunotherapeutics
• Fostering a culture of creativity, open discussion, challenge and aspire to drive innovation
• Building a strong external network to facilitate the mission to achieve key goals and realize the opportunities (solutions for patients and opportunities for assets)
• Developing and implementing a global bedside-to-bench translational science in partnership with R&D head to drive the development of objectives that are actionable and insightful and at the same time fully aligned to strategic development priorities

Requirements:

• A Medical degree and board certification in Hematology/Oncology or Medical Oncology and 8+ years Medical Affairs experience within the pharmaceutical industry in the cell therapy or similar experience; or equivalent combination of education and experience.
• Experience in conducting CAR, TIL, TCR, or similar cell therapy clinical trials is strongly preferred
• Proficiency in clinical data review and interpretation
• Experience in writing and/or reviewing clinical study protocols, IND submissions, and other regulatory documents
• Experience liaising with the FDA
• Medical Affairs and Drug Development experiences as a pharma professional (such as project leadership, medical affairs, regulatory, clinical, and/or technical operations)
• Track record of contribution to medical/ clinical development strategies
• Track record of leading cross-business/cross-functional planning, collaborating, and solution building
• Excellent oral and written communication skills
• Enthusiasm for working in a matrix environment, with demonstrated skills in collaboration.
• Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand, climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Must have the ability to handle more than one task simultaneously and must work at a rapid pace while maintaining attention to detail. Up to 20% domestic and/or international travel is required.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes, and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids, and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, glasses, and gloves. The noise level in the work environment is usually moderate.

Lentigen Technology Inc., a Miltenyi Biotec company, is transforming and progressing. Our culture is one of bold, scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

At Lentigen, we support the development and commercialization of novel treatments for human disease through the utilization of Lentiviral Vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells to modulate their function as the core strength of our company. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus, we strive to find solutions to both the technical and conceptual barriers to implementing gene therapy approaches for the treatment of human disease.

Lentigen Technology, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity