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