Clinical Development Medical Director *PC 1490

Your Role:

As the Medical Director, you will serve as a key member of the Clinical Development Team and will be responsible for providing hematology/oncology clinical expertise to for clinical trials design and execution. You will serve as a medical lead for assigned clinical trials. You should be able to work effectively in a matrix organization, with multiple departments involved, and with external stakeholders such as Investigators, CROs, Various Vendors, Regulatory Agencies.

Essential Duties and Responsibilities:

As a Medical Director at the Miltenyi Biomedicine (MBM) you will serve as a critical member of the Clinical Development team and will work collaboratively with other functions, such as Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, and Pharmacovigilance. You will lead development of designated clinical trials in hematology/oncology indications, participate in meetings, reviews, discussions and other interactions regarding development and conduct of clinical trials. In this role you will provide scientific and clinical guidance to the MBM Team based on your best experience and following interactions with internal and external experts such as health care providers, researchers, advocacy groups or regulatory/government agencies.

Additional responsibilities include, but are not limited to the following:

• Provide oversight, review, analysis of company sponsored clinical studies in hematology/oncology indications for the assigned pharmaceutical products.
• Plan and medically supervise clinical trials of Phase 0 to Phase IV acting as the medical leader for comprehensive scientific strategy and clinical development plan.
• Set the agenda and lead advisory boards, investigator meetings, external medical strategy forums, and other key internal and external focus meetings as necessary.
• Establish credible, scientifically based relationships with Key Opinion Leaders.
• Act as the company's medical consultant and as the therapeutic area expert to internal stakeholders.
• Stay abreast of internal and external developments, trends and other dynamics relevant to the work of clinical development group to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for designated therapeutic area.
• Maintain scientific and clinical knowledge in designated therapeutic area and participate in competitive intelligence assessments through attending scientific relevant meetings, conferences, interactions with KOL's and regular review of the current publications on at least the designated clinical development subject matter.
• Represent Clinical Development in sub-teams relevant to the designated therapeutic area.
• 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 other internal functions such as Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, and Pharmacovigilance as well as external collaborators to develop consistent language and criteria for the clinical trial documentation such as Study protocol, Informed Consent Form (ICF), Case Report Forms (CRFs), Investigator's Brochure (IB) etc. as needed.
• Author clinical trial protocols, clinical study reports and other clinical documents.
• Collaborate with Data Management, and Clinical Scientists and other functions on comprehensive clinical trials data review, serve as a Medical Monitor for assigned study/programs, and support sponsor oversight for clinical matters for outsourced clinical trials.
• Collaborate with the assigned Statistician on the preparation of statistical analysis plans.
• Collaborate with Pharmacovigilance to conduct safety monitoring activities.
• 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.
• Where assigned, act as the primary CD liaison/point-of-contact from the team for inquiries from clinical operations, clinical research organizations (CROs), etc.

Requirements:

• MD (or equivalent), Specialization/Board certification/Board qualification and solid clinical experience in hematology/oncology desired. Other relevant experience will be considered; At least 2 years of experience in the pharmaceutical industry clinical development in the role of a Medical Director or similar, experience with clinical trial design, conduct and medical monitoring; Equivalent academic and clinical experience may be considered.
• Full working knowledge of GCP guidelines.
• Strong working knowledge of the clinical development process.
• Experience in planning and execution of clinical trials, scientific publications, presentations and dissemination of clinical research data desirable.

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. The employee must occasionally lift and/or move up to 25 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 facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

The anticipated base salary range has been established at $218,600- $295,700/year. The hiring range for this position is expected to fall between $218,600-$257,200/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, is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biomedicine participates in E-Verify.