- Providesleadershipandmanagementwithin Clinical Development (CD)toprovidemedicalandscientificsupportfor products within assigned therapyarea.
- Supports development and execution of medical & clinical strategy for assigned Shire (a Takeda company)product(s).
- Overseesstudydesignand related data,includingclinicaltrialmedicalmonitoring,from Shire (a Takeda company)sponsored Phase I-IV clinical research programs ensuring that regulatoryauthority requirements, stakeholder requirements, and quality standards aremet.
- Provides primary medical leadership in execution of clinicaltrials
- PartnerswithotherShire(a Takeda company)functionstocommunicatescientificallyaccurateinformationtoexternalstakeholders, meeting appropriate legal and regulatoryrequirements.
- Actsasaseniorcompanyrepresentativeinteractingwithexternalscientificleadersand/or Regulatoryauthorities.
- Assists Business Development with assessments and intelligence on potential new productsand assists with due diligence activities asrequired
- CollaborateswithGlobalProgramLead, Head of Clinical Science, BusinessUnitLeaders, Clinical Operations, Global Drug Safety, Global Regulatory Affairs, and Global Medical Affairs to ensure that all developmentandproductsupportactivitiesforthetherapeuticarea(s)arecoordinatedandconsistent.
- Provides scientific advice within R&D (e.g. DDU, CBID), leveragingscientificexpertiseandprovidingguidanceinsupportof drug development and data evaluation
- Collaborates with Global Program Lead, Head of Clinical Science, Business Unit Leaders, Clinical Operations, Global Drug Safety, Global Regulatory Affairs, 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 R&D (e.g. DDU, CBID), leveraging scientific expertise and providing guidance in support of drug development and data evaluation.
- Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams in support of marketed products.
- Develops and maintains relationships externally through Advisory Boards, Professional Associations and Meetings to achieve clinical scientific objectives.
- Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
- Co-Leads in safety review committees and risk management activities as appropriate.
- Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
- Provides support to global publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
- May supervise 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. Can manage Junior-level Physicians.
- 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 Medical 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 medical accuracy.
- Participates in drug safety surveillance for development projects.
- Provides credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
- 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.
- Provide support for departmental initiatives and other duties as assigned.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- M.D. degree (required); Hematology training and certification (preferred).
- Experience in academic and/or clinical research (preferred)
- Experience working in rare diseases is highlypreferred
- Demonstrated ability to collaborate in a matrixedenvironment
- Experiencein submissionsofIND/CTX/NDA/BLA/MAAandinteractionswithRegulatoryauthorities globally,and/or Experience in designing and conducting Phase II-III clinical trials;and/or significant late-stage developmentresearch, andProduct Life cycle management.
- Therapeutic expertise (Hematology) preferred
- Demonstrated in-depth understanding of drug development and pharmaceutical marketing within therapy area.
- Working knowledge of regulations relating to drug development and promotional activities
- Demonstrated ability to communicate and plan effectively with other Shire (a Takeda company) 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. Ability to act as company spokesperson or scientific witness as needed.
- Strong management skills with demonstrated ability to plan for staffing needs, make hiring decisions, set goals and objectives, establish and recalibrate 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 participate in early or latemeetings/teleconferences
Availability to travel approximately 25% oftime.
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.