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Shionogi Inc. Vice President, Medical Science (Rare Diseases) in Florham Park, New Jersey

The Vice President of Medical Science serves as the Global Medical Leader, overseeing compounds targeting rare diseases and assuming the crucial responsibility of Medical Monitor for clinical studies. Responsibilities include providing comprehensive medical and scientific guidance, ensuring alignment of company clinical programs with the overarching Global Clinical Development Plan for assigned assets. Extensive interactions with Regulatory Authorities, including the FDA, as well as engagement with clinical experts and investigators, are integral to the role. Collaboration with functions such as Project Management, Regulatory Affairs, and Clinical Operations is essential to drive seamless integration of development plans, medical strategy, and operational execution. This role is both tactical and strategic, requiring hands-on involvement while shaping long-term vision and strategy.
RESPONSIBILITIES
Leading the design and execution of clinical trials specific to rare diseases, ensuring adherence to regulatory standards and ethical guidelines.
Developing comprehensive medical strategies tailored to address the unique challenges and considerations of rare diseases, including patient recruitment, endpoint selection, and data analysis.
Overseeing safety monitoring activities, including the review and analysis of adverse events, safety signals, and risk management strategies specific to rare diseases.
Providing medical oversight throughout all phases of clinical development, including protocol development, site selection, patient monitoring, and data interpretation.
Coordinating the preparation of clinical study reports, investigator brochures, and other regulatory documents relevant to rare disease clinical trials.
Leading the dissemination of study results through publications in peer-reviewed journals, presentations at scientific conferences, and engagement with medical and patient advocacy communities.
Collaborating with cross-functional teams including Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Medical Affairs to ensure alignment of medical objectives with broader organizational goals.
Coordinating the preparation of clinical study reports, investigator brochures, and other regulatory documents relevant to rare disease clinical trials.
Establishing and maintaining relationships with Key Opinion Leaders (KOLs), external experts in the field of rare diseases to gather insights, facilitate investigator-initiated studies, and advance scientific knowledge.
Staying abreast of advancements in the field of rare diseases through ongoing education, participation in scientific meetings, and engagement with professional networks to ensure the application of best practices and innovative approaches in clinical development.
Developing and delivering educational initiatives for internal stakeholders, investigators, and patient communities to raise awareness and understanding of rare diseases and ongoing clinical research efforts.
Evaluate external assets for potential in-licensing or acquisition, considering medical value, strategic alignment, and therapeutic relevance. Collaborate with business development teams to provide medical insights and support due diligence assessments.
Conduct comprehensive evaluations of internal pipeline products, analyzing clinical data, market potential, and competitive landscape to inform strategic decisions. Provide recommendations for resource allocation, prioritization, and portfolio management to maximize asset value and strategic alignment.
Other duties as assigned.
MINIMUM JOB REQUIREMENTS
Qualifications
Medical degree (MD or equivalent) with board certification preferred.
Minimum of 14 years of experience in the pharmaceutical industry required; 5 years of continuous clinical development experience in rare diseases, serving as a medical expert/medical monitor for Phase 2 and/or Phase 3 studies, or as a clinical leader for a product in Phase 2 and/or Phase 3.
Substantial experience in clinical development within the pharmaceutical or biotechnology industry, with a focus on rare diseases.
Proven track record of successful leadership in designing and executing clinical trials for rare diseases, resulting in regulatory approvals.
Strong understanding of regulatory requirements and guidelines governing rare disease drug development. Ability to write regulatory documents in clear language.
Thorough knowledge of Good Clinical Practices (GCPs) and regulatory reporting requirements, particularly in the US and internationally, for product safety is necessary.
Experience in writing and reviewing scientific and clinical research reports for regulatory submission and scientific publication is preferred.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
Demonstrated ability to think strategically, analyze complex medical data, and make informed decisions.
Commitment to continuous learning and professional development in the field of rare diseases.
Ability to travel up to 25%, including international travel (e.g., to Japan), may be necessary.
Competencies
Deep understanding of rare diseases, including their pathophysiology, natural history, and clinical manifestations, is essential. Strong clinical knowledge and experience in diagnosing and managing rare diseases.
Comprehensive knowledge of drug development processes, including clinical trial design, regulatory requirements, and safety monitoring procedures specific to rare diseases. Familiarity with orphan drug regulations and incentives is also important.
Ability to think strategically and develop comprehensive medical strategies...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

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