Medical Director - Immunology/Dermatology at Millipore Corporation in BILLERICA, Massachusetts

Job Description:

Serve as the medical director responsible for clinical trial(s), overseeing execution of clinical trial activities in assigned projects.Manage a cross-functional development team to define clinical trial activities that best support the overall program strategy. Oversee and lead the planning and management of clinical trials, including study design, trial management and interpretation of results from a medical perspective.- Responsible for a cost-effective approach to development plan activities.Serve as Medical Trial Director:· Ability to engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials· Develop and/or oversee the preparation of clinical development plans, study concept sheets, study protocols or regulatory documentation in collaboration with clinical and project team members for assigned indication(s)/products or with external partners for collaborative studies· Actively contribute to or oversee medical writing of medical sections of study protocols, investigator brochure and other regulatory documents· Manage, mentor and develop assigned staff, as appropriate· Co-leadership of trial teams· Oversee all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders· Support the review, analysis and interpretation of study data· Support communication of study results as assigned· Stay up to date in the assigned therapeutic area and sub-area including oversight of significant new developments· Contribute to the progress of the organization by providing input into assigned business process improvement workstreams and tasksEDUCATION & LANGUAGESMedical Degree (mandatory)Board certification or expertise in related Immunology/Dermatology field preferred but not mandatory.Able to communicate effectively in EnglishStrong medical writing skillsPROFESSIONAL SKILLS & EXPERIENCERequires substantial professional experience in Immunology/Dermatology including clinical trialsAt least 2 years (associated medical director / medical director, respectively) experience in the pharmaceutical or biotechnology industry preferred including knowledge of regulatory requirements in clinical developmentExperience in design, set up, conduct and evaluation of clinical trialsExperience working in a cross-functional multi-site team environmentPERSONAL SKILLS & COMPETENCIESAbility to work in an intense, fast paced, global work environmentPro-active, problem-solving, constructive attitudeStrong oral and written communication skills, including presentations (posters, paper, seminars) to internal and external partiesAbility to collaborate in a seamless fashion with project/program/functional teams both face to face and remotelyAbility to process complex medical-scientific topics and translate them into clinical development scenariosAble to maintain familiarity with rapid progress in the field