- Providing leadership and management within CD to provide scientific and clinical development support for products within assigned hematology therapy area(s).
- Support development and execution of medical & clinical strategy for assigned Shire product(s).
- Preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
- Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
- Leading the interpretation of trial data and development and review of clinical study documents, reports etc,
- Provide relevant expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables.
- Address medical questions or clarify issues arising during conduct of the study
- Participation/contribution to cross-functional team meetings; Interact with external scientific leaders and/or Regulatory authorities.
- Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required.
- Review, analysis and report clinical trial data
- Medical review of clinical trial data.
- Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution.
- Collaborates with Global Development Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provides scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific and clinical development expertise and providing guidance in support of brands and product launches.
- Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
- Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
- May supervises a variable number of CD professional and administrative staff; responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems.
- Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
- Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs.
- Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
- Participates in drug safety surveillance for Development projects.
- Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
- Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
EDUCATION and EXPERIENCE REQUIREMENTS:
- Medical Doctor (MD) is preferred, or PhD in related therapeutic discipline plus pharmaceutical industry experience will be considered.
- Experience within Hematology or related discipline.
- Three to five years experience in clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.
- Demonstrated ability to collaborate in a matrixed environment
- Experience with interactions with Regulatory authorities.
- Experience in designing and conducting Phase II-III clinical trials.
- Expertise in hematology and hemophilia management is preferred
- Experience in rare diseases highly desired
- Demonstrated in-depth understanding of drug development and pharmaceutical marketing within Therapeutic area.
- Working knowledge of regulations relating to drug development and promotional activities
- Demonstrated ability to communicate and plan effectively with other Shire departments and to respond to inquiries or complaints from customers.
- Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences.
- Strong management skills with demonstrated ability to plan for staffing needs, make hiring decisions, set goals and objectives, establish and re-calibrate priorities, provide feedback and appraise work. Ability to regularly assess individuals skills, talents and career interests which ensure development of a talent pool for the future. Ability to create and maintain and organizational structure that serves the needs of the business.
- Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results.
- Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization.
- Strong business acumen preferred with the ability to shape corporate strategy using knowledge of the global pharmaceutical industry.
- Ability to capitalize on business opportunities by developing well thought out strategies and initiatives.
- Availability to travel approximately 25% of time.
- Availability to participate in early or late meetings/teleconferences.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.