Posted to MedZilla on 8/16/2018


Takeda Pharmaceuticals

US-MA, Senior Medical Director Pharmacovigilance - Neuroscience R0000622-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Medical Director, Neuroscience in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Medical Director working on the Global Medical Safety team, you will be empowered to innovate and develop strategies for a best in class Safety Organization. A typical day will include:

POSITION OBJECTIVES:

  • Responsible for the leadership and oversight of a therapeutic area and management of physicians who serve as the Global Safety Leaders (GSL) for both developmental and marketed compounds in designated therapeutic area.
  • The Senior Medical Director will also act as the GSL for one or more products.
  • The Senior Medical Director will interact with and influence cross functionally within designated therapeutic area (Clinical Operations, Regulatory Affairs, Analytical Science, Clinical Science, etc.) to ensure the successful development, design and implementation of comprehensive safety assessment protocols for both developmental and marketed products.
  • The Senior Medical Director will oversee signal detection and risk management activities in the assigned therapeutic area and ensure that development plans include comprehensive safety assessment plans.
  • The Senior Medical Director will be a key player in the preparation and presentation of materials to the Safety Board and similar forums.

Specific to this role, key competencies/experience include:

  • Significant Neuroscience experience in a clinical development or medical safety lead role.
  • Therapeutic experience in this field would be advantageous but not mandatory
  • Experience with biologics and / or novel therapeutics (e.g. cell and gene therapy)
  • Experience managing direct reports in a matrix organization

POSITION ACCOUNTABILITIES:

  • In conjunction with VP Global Medical Safety/Executive Medical Director, will lead and direct the interpretation of safety data from internal and external studies. To communicates at senior leadership level the impact of such data in terms of go/no go decisions or modification of development plans and/or study designs and the associated impact on timelines and/or labeling
  • Responsible for reviewing, analyzing and interpreting information from ongoing clinical and non-clinical studies alongside the assessment of ensuing scientific and medical implications and making recommendations based on new safety information for both developmental compounds and marketed drugs to ensure the primacy of patient safety.
  • Participates with colleagues in other Global Safety Functions in the development of a global consensus on signal detection tools and activities
  • Viewed as the SME in PV Medical Safety for the assigned therapeutic area, mentors other PV physicians with respect to compounds in development and market drugs, safety monitoring and risk management assessment and analysis.
  • Supports cross functional (within and outside Global PV) team evaluations in preparation for Takeda Safety Board presentations as well as having the leadership role for assigned products in safety data presentations to Safety Board
  • Integral to the Global Product Team for his/her compound responsibilities
  • Attends corporate committees such as the Therapeutic Area Teams and Development Review Committee representing the assigned therapeutic area(s).
  • Directly responsible/ oversees the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).
  • Directs PV interactions with Regulatory authorities
  • Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues
  • In conjunction with Risk Management and Pharmacoepidemiology oversee risk management plans for developmental and marketed drugs
  • Proactively identifies safety concerns and associated contingency strategies and/or oversee physician colleagues re same
  • Manages PV physicians in the preparation, analysis and presentation of safety information
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities
  • Line management and/or function responsibilities commensurate with a skilled and experienced physician

EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Medical degree required or internationally recognized equivalent.
  • Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development. Experienced in supporting submissions to regulatory agencies, including aggregate analysis of safety data
  • Direct clinical experience with patients following post-graduate training with appropriate grounding and knowledge of general medicine.
  • Minimum 3 years people management experience and/or proven leadership experience in managing a global, matrix team.
  • Excellent communication skills
  • Demonstrate integrity
  • Relate well to people at all levels
  • Motivate and empower others
  • Work productively in a high pressure environment
  • Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
  • Project Management abilities
  • Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously
  • Attention to details, computer literacy, knowledge of safety database
  • Take initiative and autonomous action
  • Able to lead teleconferences and meetings
  • Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills

TRAVEL REQUIREMENTS:

Some travel within Takeda global sites may be required.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com

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