Posted to MedZilla HealthCare on 11/14/2019


Takeda Pharmaceuticals

US-MA, Epidemiology Leader SR0041987-MZ


 
 

The Director, Epidemiology is a high-level, strategic and scientific role that involves developing, coordinating, and executing cutting-edge, effective, and impactful epidemiology research for product support at a global level, from early development through life cycle management. The Director, Epidemiology provides essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact cross-functional project opportunities and risks, to ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs. The incumbent must be highly innovative, proactive and collaborative with mature team-working behaviors. As a member of the Outcomes Research and Epidemiology (ORE) department, an epidemiologist at Shire must have a broad view of the role of epidemiology and Pharmacoepidemiology in product support, contributing across target identification, through drug development, value demonstrations, market access, and post-approval effectiveness and safety. Epidemiologists interact with a wide range of internal and external customers to ensure appropriate communication of epidemiological issues and study results to stakeholders, including providing epidemiological support for interactions with regulatory authorities.

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

15%

Develop product epidemiology strategy for drug development, pharmacovigilance, and commercial purposes across the product life cycle

35%

Propose, design, initiate, conduct, manage, report, and present epidemiologic studies, following through on all review stakeholder management, and compliance processes

15%

Critical appraisal and synthesis of relevant epidemiological literature, including to support exploration of new disease areas

10%

Contribute appraisal and synthesis of relevant epidemiological literature, including the support exploration of new disease areas

15%

Pharmacovigilance support, including risk management; PASS development and delivery; contributions to RMPs, PSURs, and regulatory responses; understanding inherent risks associated with a given product s indication; providing population-level context for safety; understanding and responding to potential safety issues

10%

Maintain awareness of regulatory requirements, payer trends, external pharmacoepidemiologic initiatives, and advances in pharmacoepidemiologic methodology; support strategic development of the Epidemiology function within Shire; remain current on the capabilities of key external research partners.

Education and Experience Requirements

Include educational requirements or equivalency, required years and type(s) or experience, and

necessary licenses or certificates. Specify which are required and which are preferred. For UK,

please do not use years of experience due to UK Legislation

  • PH.D. in epidemiology or a related field, or a Master s degree in epidemiology, and a least 10 years preferred experience in life science related field is preferred
  • Sustained productivity in epidemiological research, as manifest by successful design, execution, and publications of epidemiological research, including through extensive collaboration with external investigators, as well as recognition by the external scientific communities as an expert in areas relevant to drug development, pharmacovigilance, and commercialization, from early development through life cycle management
  • Preferred: experience with epidemiology of orphan drugs, comparative effectiveness research, personalized medicine, direct interaction with regulatory authorities, patient risk management program evaluation, business development due diligence

Key Skills, Abilities, and Competencies

Describe critical skill and abilities needed to successfully perform the job, which should be

representative of the knowledge, skills, and abilities required. Reasonable accommodations may be

made to enable individuals with disabilities to perform the essential functions.

  • Thorough knowledge of epidemiological methodology and its applications to the pharmaceutical industry at an international level
  • Comprehensive knowledge of drug development and life cycle management, as well as business strategy, drug commercialization, pharmacovigilance, and patient risk management
  • Ability to proactively identify opportunities and anticipate needs for programs supported
  • Thorough familiarity with relevant regional and international regulatory requirements
  • High degree of initiative, proactivity, flexibility, and ability to work independently in a face-paced environment
  • Proven team-working, leadership, follow-through, stakeholder management, organizational awareness, and project management skills, within a complex, multi-disciplinary, team-based environment
  • Ability to respond to changes in the internal and external environments by adjusting plans or developing new ways of working
  • Superb written and oral communication and influencing skills, and cultural sensitivity
  • Ability to effectively engage with a wide variety technical and business experts
  • Expert knowledge of large databases relevant to epidemiologic research in the US and internationally
  • Demonstrated ability to prioritize and simultaneously manage multiple competing task and demands, delivering to timelines with high scientific quality, while being both strategic and detailed

Complexity and Problem Solving

Describe the decisions made by the incumbents on a regular basis. Include decisions within the

Incumbent s authority to make as well as those decisions that must be referred to a higher level.

  • Ability to make complex judgments, develop innovative solutions, and apply comprehensive cross-functional and industry understanding to individual projects and programs
  • Insight on when and how to access and effectively engage and consult external resources and scientific experts
  • Effectively represent the Company to external stakeholders, including regulatory authorities and key scientific opinion leaders
  • Consider and communicate global, local, and future implications of strategic and project decisions, simultaneously meeting scientific and business objectives
  • Ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs

Internal and External Contacts

List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the

job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and

provide examples.

  • Internal and external contacts are US-based as well as International
  • Internal: Outcomes Research, pharmacovigilance, risk management, regulatory affairs, clinical development, medical affairs, biostatistics, clinical operations, market research, forecasting, external communications, project management, market access, pricing & reimbursement, business insight, commercial operations
  • External: regulatory authorities, epidemiology and clinical key opinion leaders, epidemiology and clinical investigators, data vendors, CROs

Other Job Requirements

List any other job requirements, including travel, physical abilities required, etc.

Domestic and international travel required. Must have a global mindset. Fluency in main European languages would be desirable.

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

Reasonable Accommodations

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.


Please visit our website at takedajobs.com

 
 


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