Vacancy expired!
Job Description
The position of AssociateMedical Director MD, Clinical Development sits within the neuropsychiatry and pain subunit of the Therapeutics Development Unit (TDU). The associatemedical director will have direct responsibility for advancing clinical development across phases through clinical study design and execution as well as interpretation and communication of the study data. You will interact with multiple levels of management within Biogen, external stakeholders in the medical community.
The position of Associate Medical Director, Clinical Development, sits within the neuropsychiatry and pain subunit of Therapeutics Development Unit, a disease unit of Biogen that includes multiple disease areas of focus across neuroscience. The associate medical director will support clinical development programs in pain , and responsibilities may extend to other disease areas in the TDU as business needs require. In addition, youwill have the potential opportunity to function at a high level across multiple studies, disease areas, and across different phases of development (eg, Phase 1-3).
Key activities include responsibility for advancing high priority clinical studies through clinical study design and execution, medical oversight, and medical / clinical development leadership on study teams, and potentially project teams.
Duties may include (but are not limited to), some or all of the following, depending on current business needs:
- Provide medical leadership for programs that integrates the individual’s knowledge in in basic science, drug development, and medical practice with input from the medical community around the world.
- Provide ongoing medical expertise and medical oversight of clinical trials, and serving as a medical monitor, partnering with external and internal stakeholders
- Support conceptualization and development of clinical trials in conjunction with multiple functions, including development from inception of trials in new indications
- Author, with colleagues, a variety of trial related documents (eg, investigator brochures, responses to regulatory authorities and institutional review boards, clinical study reports)
- Successfully interface with key medical experts and represent Biogen at medical congresses and conferences
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework in support of executing the Clinical Development Plan (CDP) Develop and maintain relationships with program counterparts across the organization
- Contribute to franchise strategy and growth, and potentially participate in business and corporate development activities
- Flex across Phases 1-3 and potentially across multiple disease areas as business needs evolve
You are a proven leader within the Clinical Development, Neuroscience / Neuropsych space and strive on developing, executing and advancing a strategic and successful development program. You have experience managing high performing teams; providing the necessary guidance and mentoring for all to reach their goals
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Qualifications
MD, MD/PhD, or PhD required; experience in a pharmaceutical company or related vendor is preferred; clinical or research experience in neuroscience and/or pain is preferred.- One (1) to three(3) years of experience in clinical trials with a proven record of achievement on independent research projects or record of achievement in a relevant clinical practice area
- Pharmaceutical industry experience from a sponsor or related vendor is preferred
- Ability to think strategically, focusing on the long-range vision and needs of multiple key stakeholders
- Ability to compile and present development plans, study designs, analyses of data in forums consisting of individuals representing a variety of functions (ie, both with and without scientific backgrounds)
- Superb communication skills (verbal and written), presentation skills and organizational skills, with ability to multi-task
- Advanced facility with office software, and ability to independently create and work with documents, slides, and spreadsheets
- Able to work collaboratively in a multi-disciplinary team setting and employ a team approach to decision-making
- Upon and if conditions permit, ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings; and ability to engage with multiple stakeholders virtually as required
Additional Information
The position of AssociateMedical Director, Clinical Development sits within the neuropsychiatry and pain subunit of the Therapeutics Development Unit (TDU). The associate medical director will have direct responsibility for advancing clinical development across phases through clinical study design and execution as well as interpretation and communication of the study data.
Vacancy expired!