Responsible for the development and execution of the clinical development plan and the lead of the clinical science team. Responsible for the development and review of synopses, protocols, Critical Study Flash Results and clinical study reports with the team. Provide leadership, mentoring and management of team members. Responsible for providing guidance to TA leaders within the Therapeutic Area.
- Accountable to Therapeutic Clinical Science Head to provide strategic clinical input
- Accountable for ensuring that there is a global clinical strategy and that stakeholders are appropriately briefed.
- The Executive Clinical Science Director supports the Global Program Director (GPL) on all global objectives and ensures that the clinical science view is represented in the global strategy by:
- Providing clinical leadership and oversight within TA
- Integrating and consolidating input from all relevant parties into the clinical science view on the Clinical Development Plan (PV, Regulatory, Stats, Clinical operations etc).
- Represent the Clinical Science Team on the GPT
- Represent the Clinical Science Team as needed on the, DRF, SPRB, GI TAU Cross functional meetings, the PRC and any other governance body as appropriate
- Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)
- Interface with Medical Affairs for strategy and in support of product commercial efforts as needed
- Contributing to the creation and maintenance of the KOL network
- Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation
- Line manage other clinical science staff within the TA
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Responsible for the quality of the synopses and protocols from the team relating to the assigned compound(s).
- Rotating member to critically review synopses and protocols of other teams at SPRB
- Responsible for study execution and study interpretation of the assigned compound(s)
Trial Medical Monitoring
- Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.
- Oversees and leads all clinical science activities involved in interactions with FDA and key opinion leaders relevant to assigned compounds.
- Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the context of the global development.
- Proactive identification of challenges and development of contingency plans as appropriate.
Due Diligence, Business Development and Alliance Projects
- Responsible for evaluation of potential business development opportunities for the TAU
- Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities.
- Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda s strategic goals while striving to maintain good working relationship between Takeda and partner.
- Assigns and manages clinical science staff who are involved in many of these activities.
Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound. Leads CST with Clinical operations.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- MD strongly preferred or internationally recognized equivalent with minimum 10 years pharmaceutical research experience, including minimum 7 years phases I-IV experience.
- Management experience in a matrix environment.
- Gastroenterologist preferred but not mandatory.
- Willingness to travel to various meetings or KOL sites, including overnight trips. International travel will be required.
- Requires approximately 25 % travel.
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.
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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.