Posted to MedZilla on 11/19/2018


Takeda Pharmaceuticals

US-MA, Senior Medical Director - GI/Immunology (Clinical Development) R0002961-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 Medical Director/Senior Medical Director, Neurology in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Director/Senior Medical Director working in the Gastroenterology (GI) Therapeutic Area Unit, you will be empowered to lead and drive strategy for global clinical development, and a typical day will include:

OBJECTIVE:

  • The Senior Medical Director will take on a strategic and leadership position within the GI TAU, focusing on the ongoing development of vedolizumab
  • The Senior Medical Director will lead a multi-disciplinary, multi-regional, matrix team through the ongoing development and filing of vedolizumab SC. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to maintain, and execute a global clinical development plan that will result in the regulatory approval of vedolizumab SC in multiple regions. Applies clinical/medical decision making to clinical development issues.
  • The Senior Medical Director will be responsible for the management and career development of Medical Directors / Associate Medical Directors who would be reporting directly to her/him.

ACCOUNTABILITY:

Vedolizumab SC Clinical Team Lead

  • Will lead the Global Development Team (US, EU, Japan) managing both the US/EU Development Team and the Japan Development team for vedolizumab SC. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.
  • Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
  • Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.

External Interactions

  • Directs activities involved in interactions with regulatory authories / agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.

Due Diligence, Business Development and Alliance Projects

  • Responsible for identification and evaluation of potential business development opportunities, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC.
  • Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda s strategic goals while striving to maintain good working relationship between Takeda and partner. Provides guidance to clinical scientists who are involved in some of these activities.

Leadership, Task Force Participation, Upper Management Accountability

  • As the Clinical Lead for the vedolizumab SC program, the Senior Medical Director will keep the Entyvio GCL updated on all aspects of the program, and will be responsible for leading the team at all presentations to various governance committees including SPRB, CST and GPT
  • As applicable, hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities, and may conduct performance reviews and drive goal setting and development planning.

EDUCATION and EXPERIENCE:

  • MD or internationally recognized equivalent preferred, plus at least 7 years experience of clinical research experience within the pharmaceutical industry
  • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Development experience beyond US/EU a plus.
  • BLA/NDA/MAA/Submission experience preferred
  • Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred

Skills

  • Superior communication, strategic, interpersonal and negotiating skills
  • Ability to proactively predict issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Diplomacy and positive influencing abilities across multinational business cultures

Knowledge

  • Therapeutic area knowledge relevant to mechanisms of action of compounds in remit
  • Regional/global Regulatory requirements
  • GCP/ICH
  • Emerging research in designated therapeutic area

LICENCES/CERTIFICATIONS:

  • MD or internationally recognized equivalent preferred

TRAVEL REQUIREMENTS:

  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 15 - 25% travel.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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