Posted to MedZilla on 8/23/2019


Takeda Pharmaceuticals

US-MA, Associate Medical Director, Clinical Science - Oncology R0009212-MZ


 
 

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Job Description

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 Associate Medical Director, Clinical Science - Oncology in our Cambridge office.

OBJECTIVES:

The Associate Medical Director leads and drives strategy for the overall clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compound(s). Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences Clinical Science Team (CST) and/or Global Program Team (GPT) decision making by setting strategic direction. Success or failure directly translates to the ability of Oncology Clinical Research to meet its corporate goals and for Takeda to have future commercial products.

ACCOUNTABILITIES:

  • Clinical Development team participation and leadership

Responsible for providing support to the Global Clinical Lead (GCL) for global clinical development plan. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Ongoing work output will involve 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. Recommends high impact global decisions. Responsible for 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.

  • Synopsis / Protocol Development, Study Execution, & Study Interpretation
    • Oversees all Clinical Science activities relating to the preparation /approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to CRO and other cross-function team member involved in these activities, and be accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
    • Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
  • Trial Medical Monitoring
    • Responsible for overseeing medical monitoring activities, assessing issues related to protocol conduct and/or data integrity
    • Accountable on final decisions regarding study conduct related to scientific integrity with the support of GCL
  • External Interactions
  • Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Provides leadership in meetings and negotiations with key opinion leaders and regulatory agencies.
  • Lead incorporation of established strategy for assigned compounds in developing documents required for regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.
  • Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.
  • Leadership, Task Force Participation, Upper Management Accountability
    • Represents clinical science and leads internal task forces and global cross-functional teams as appropriate. Interacts with research division based on pertinent clinical and development expertise and with commercial or medical affairs to provide scientific and medical knowledge and facilitate understanding of pertinent market environment as scientific content matter expert for assigned compounds.
    • 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 or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
  • Medical practice or research in oncology is preferred.
  • Previous experience successfully managing CRO and regulatory interaction 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

Knowledge

  • Knowledge of clinical drug development
  • Knowledge of clinical study design (including statistical interpretation)
  • Clinical and translational knowledge relevant to lung cancer is preferred
  • GCP/ICH

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 10 - 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 attakedajobs.com.

No Phone Calls or Recruiters Please.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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