Kelly Services is actively recruiting for a Senior Clinical Medical Director for a long-term REMOTE opportunity.
The Sr. Medical Director will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
The Senior Medical Director for the Marketed Products Group (MPG) leads and drives strategy for the overall global and regional clinical development programs of assigned products, taking into consideration the medical, scientific, regulatory and commercial issues. Will be expected to work in a collaborative fashion across different functions and levels of management but able to accomplish tasks with the independence, based on task demands, work experience and skills, and decision-making process.
The Sr. Medical Director will lead a multi-disciplinary matrix team through simple and complex decisions, by assessing and integrating input from various functions and disciplines with the goal of creating and executing clinical development plans with the highest scientific and ethical standards and applicability to specific regulatory requirements. The Sr. Medical Director will interact with and influences MPG senior leadership decision-making by setting strategic direction and updating on implementation progress and issues.
Responsibilities of the Sr. Medical Director (Clinical Science) will be as follows:
Clinical Science activities related to the planning of clinical trials, including preparation and presentation of clinical trial synopses and protocols for review and approval by MPG senior leadership
Oversight of medical monitoring activities, assessment of issues related to protocol conduct and individual subject safety and toleration, preserving the highest standard of scientific integrity and ethics
Assessment of overall safety data for assigned products in collaboration with Safety and Pharmacovigilance
Interpretation of results of clinical trials and internal subject matter expertise for the assigned products and related therapeutic area also for potential due diligence assessment of licensing opportunities
Resource to Clinical operations for direction and management of collaborations with Clinical Research Organizations (CRO) and other cross-functional team members involved in the execution of clinical trials
Resource to Regulatory affairs for expertise, responsibility and leadership on preparation and presentation of clinical/medical components of regulatory filings and for interactions with Regulatory Authorities
Presentation of study results to internal and external audiences and assessment of study results’ impact on the overall product strategy
Identification, engagement and management of key opinion leaders relevant to assigned products and therapeutic area for the consultation needs that the S/MD responsibilities might require.
Qualifications required for the Sr. Medical Director (Clinical Science) will be as follows:
Medical degree or internationally recognized equivalent with 5-10 years of clinical research experience (also combined) within the pharmaceutical/biotech industry or CROs.
Experience in Oncology is preferred.
Superior communication, strategic, interpersonal and negotiating skills.
Ability to proactively predict/identify issues and research/understand their root causes.
Pragmatic approach to problem solving.
Ability to drive decision-making within multi-disciplinary, matrix teams, while stimulating feedback and respecting diversity and potential differences of input.
Diplomacy and positive influencing abilities.
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At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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