Clinical Scientist *PC 1539

Your Role:

This position will lead and/or participate in meetings, reviews, discussions and other interactions regarding early development of Phase I and Phase II pivotal studies to provide clinical science input and guidance to the Biomedicine, Inc. team.

Essential Duties and Responsibilities:

• Develop the Biomedicine Global Clinical Development plan in collaboration with the Clinical Development Physician for assigned indication(s).
• In collaboration with Clinical Development Physicians/Medical Director, develop innovative clinical study designs.
• Review protocols and provide Clinical Development input into the early development of Phase I and Phase II pivotal studies.
• Review and/or write additional clinical science documentation and/or clinical science input into other documentation managed by Biomedicine (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.).
• Gather, analyze and summarize data and information necessary to create the Clinical Development plan.
• Lead the response generation or assists Clinical Development team in responding to clinical/clinical site inquiries.
• Stay abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).
• Maintain scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment and participate in competitive intelligence assessments.
• Represent Clinical Development in sub-teams relevant to assigned therapies/indication(s). As needed and appropriate, address Clinical Development study or other program-specific questions; provide updates; deliver presentations; etc. May act as the lead Clinical Development representative on sub-teams.
• Support the completion and submission of regulatory filings and other regulatory documentation.
• Deliver key presentations, both internally and externally, to convey the Clinical Development perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing the company.
• Collaborate with clinical operations, other groups and Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc.
• As needed/appropriate, collaborate with others in the review of safety narratives and other safety-related guidelines and participate in safety meetings and track, analyze and report any potential safety events.
• Provide clinical and scientific support with site training, as needed, or requested
• Where assigned, act as the primary CD liaison/point-of-contact from the team for inquiries from clinical operations, clinical research organizations (CROs), etc. Responsibilities include:




• Respond to questions from other internal and external parties regarding assigned studies and programs.
• Collaborate with Clinical Development Physicians, clinical operations, data management and other groups to conduct clinical review of study data.
• Review, analyze, present and discuss clinical study reporting documents with internal and external audiences.
• Work closely with Clinical Development Physicians, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting.
• Participate in the development and implementation of communications strategies to support existing and concluded studies.
• Lead or contribute to writing or, if applicable, writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinate submissions to scientific meetings and/or other appropriate venues or groups.

Requirements:

• Advanced degree (MBA, MPH, PharmD, PhD) preferred; 2-5 years' work experience, Data listing review experience and familiarity with standard clinical and regulatory references such as CTCAE, MedRa, etc.; Or an equivalent combination of education or experience
• Experience in the principles and techniques of data analysis, interpretation with a solid fundament of statistical principles.
• Experience authoring experimental protocols and/or study results and conclusions.
• Relevant therapeutic area experience in hematology or oncology. Experience in gene and cell therapies is beneficial.
• Indepth understanding and experience with BLA filing.

Knowledge, Skills & Abilities:

• Strong interpersonal skills with the ability to effectively interact with other scientists and clinicians and the ability to influence others without a formal reporting relationship.
• Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, and other relevant guidelines and regulations.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

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, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment. This job requires the person to occasionally travel to visit other sites.

The hiring range for this position is expected to fall between $129,300- $152,150/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biomedicine, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.