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 to address the unique challenges associated with rare diseases. This includes identifying innovative approaches to patient recruitment, endpoint selection, and data analysis.
Strong leadership skills are essential for guiding cross-functional teams and driving the successful execution of clinical development programs. Ability to inspire and motivate team members toward common goals.
Excellent communication skills, both verbal and written, are crucial for effectively communicating complex medical concepts to diverse stakeholders, including internal teams, external experts, regulatory agencies, and patient advocacy groups.
Ability to collaborate effectively with cross-functional teams, including Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Medical Affairs, is essential. Ability to foster a culture of teamwork and collaboration to achieve shared objectives.
Strong analytical and problem-solving skills are necessary for identifying and addressing challenges that arise during the clinical development process. Able to quickly analyze data, identify trends, and develop solutions to overcome obstacles.
Committed to upholding the highest ethical standards and ensuring compliance with regulatory requirements throughout the drug development process, prioritizing patient safety and data integrity at all times.
Ability to adapt to changing priorities, timelines, and circumstances is critical in the fast-paced environment of clinical development.
Commitment to continuous learning and professional development is essential for staying abreast of advancements in the field of rare diseases and emerging trends in clinical research methodologies.
Other Requirements
This position has significant managerial and decision-making authority.
Ability and willingness to travel approximately 25% of the year both domestically and internationally
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month
ESSENTIAL PHYSICAL REQUIREMENTS
Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Ability to travel via automobile and/or airplane.
Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
Ability to operate a computer keyboard and telephone.
Ability to sit for extended periods of time – up to four (4) hours at a time.
Ability to lift, tug, pull up to fifteen (15) pounds.
To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.
DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.
EEO
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
