Posted to MedZilla on 9/19/2017


Takeda Pharmaceuticals

US-MA, Medical Director, Clinical Development (Dengue) - Vaccine Business Unit 1701681-MZ


 
 

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 Medical Director, Clinical Development (Dengue)in our Cambridge, Massachusetts office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Medical Director, Clinical Development (Dengue)working on the Vaccine Clinical Developmentteam, you will be empowered to make meaningful contributions, and a typical day will include:

OBJECTIVES:

Leading and driving the strategy for the overall global clinical development in the assigned area, taking into consideration the medical, scientific, regulatory and commercial issues. Lead a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the expertise for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned area in multiple regions. Applies clinical/medical decision making to clinical development issues.


ACCOUNTABILITIES:
  • Clinical Development team participation and leadership
    • Leads the Global Development Team managing both the US/EU Development Team and the Japan Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the clinical scientist responsible for leading this team. 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. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
  • Synopsis / Protocol Development, Study Execution, & Study Interpretation
  • Trial Medical Monitoring
    • Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with Pharmacovigilance.
  • External Interactions
    • Directs activities involved in interactions with regulatory authorities/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 evaluation of potential business development opportunities with regard to clinical development. 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.
    • 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.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
  • Medical Degree or internationally recognized equivalent with the relevant industry experience and 5 years of clinical research experience within the Vaccines industry or CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
  • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions strongly preferred.
  • 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

PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Carrying, handling and reaching for objects.

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 20% travel.

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.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-KB1-USA


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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