Posted to MedZilla on 2/22/2020


Takeda Pharmaceuticals

US-MA, Scientific Director, Clinical Science, Oncology R0016875-MZ


 
 

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Scientific Director, Clinical Science, Oncology in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliverBetter Health and a Brighter Futureto people around the world.

Here, you will be a vital contributor to our inspiring, bold mission. As Scientific Director, Clinical Science team member, you will be empowered to contribute to Takeda s mission.

OBJECTIVES:

This position is responsible for the strategic leadership and scientific direction for the overall global (US/EU) clinical development for assigned Takeda pipeline compound(s). 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. This individual interacts with and strongly influences GCDT leadership decision-making by setting strategic direction and providing expert therapeutic area and clinical development input Provides clinical expertise and interacts with regulatory agencies such as the FDA and EMEA. Success or failure directly translates to the ability of R&D to meet its corporate goals and for Takeda to have future commercial products.

ACCOUNTABILITIES:

  • Critically reviews technical and scientific reports from external sources.
  • Resolves complex technical issues and ensures that the highest scientific standards are used in support of clinical development studies.
    • Provides scientific expertise to functional area representatives of GCDT on disease state, study design, and scientific rationale in clinical studies for compounds within therapeutic area
  • Authors/supports publication and presentation of clinical and nonclinical data in support of Takeda developed or licensed compounds.
  • Ensures quality of Regulatory Affairs clinical submissions, manages Clinical Development issues, and helps to develop interface between R&D and other functional areas.
  • Generates and reviews clinical regulatory documents: Investigational New Drug (IND) Applications, Briefing Documents, Investigational Brochures, Investigational Product Labeling, IND annual reports, Investigational Medicinal Product Dossiers (IMPD), common technical documents as the basis for new drug applications (NDA) and Marketing Authorization Applications, other EMEA/CHMP regulatory documents and scientific white papers.
    • Collaboratively interacts with scientists from alliance partners.
  • Establishes, maintains and directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Participates in meetings and negotiations with key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.
  • Serves as internal expert on clinical development with high degree of accountability.
  • Identifies, develops, recommends and/or negotiates novel (but scientifically sound) solutions to meet critical business needs.
  • Provides on-going 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.
  • Oversees and monitors clinical development studies, including study design, study conduct and procedures for data analysis, quality control and report preparation. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
  • Identifies, develops and communicates/negotiates criticality of new scientific tools for effective and thorough clinical development studies.
  • Provides input to go/no go decisions.
  • Prepares clinical development summaries for NDA, IND and other regulatory submissions.
    • Responsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing both scientific and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
    • Leads cross functional, cross divisional, cross regional development teams
    • Recruit and retain staff as applicable

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • Bachelor s in Science, professional license and at least 18 years experience in a scientific discipline with expert knowledge of pharmacology or medicine and working knowledge of other disciplines such as toxicology, physiology, metabolism, biochemistry, chemistry, statistics and experimental design. This includes an understanding of current scientific approaches, problem solving techniques and statistics used in experimental work.
  • Master s and at least 16 years experience in a scientific discipline with expert knowledge of pharmacology or medicine and working knowledge of other disciplines such as toxicology, physiology, metabolism, biochemistry, chemistry, statistics and experimental design. This includes an understanding of current scientific approaches, problem solving techniques and statistics used in experimental work.
  • PharmD and at least 15 years experience in a scientific discipline with expert knowledge of pharmacology or medicine and working knowledge of other disciplines such as toxicology, physiology, metabolism, biochemistry, chemistry, statistics and experimental design. This includes an understanding of current scientific approaches, problem solving techniques and statistics used in experimental work.
  • PhD and at least 12 years experience in a scientific discipline with expert knowledge of pharmacology or medicine and working knowledge of other disciplines such as toxicology, physiology, metabolism, biochemistry, chemistry, statistics and experimental design. This includes an understanding of current scientific approaches, problem solving techniques and statistics used in experimental work. MD may substitute for PhD. with suitable experience
  • At least 5 years experience in designing and running clinical trials.
  • Must have significant pharmaceutical industry experience.
  • Must have scientific and technical expertise as evident by publications, patents, awards/honors and credibility at professional societies. Alternatively, must have evidence of successful utilization of scientific and technical principles in negotiations of business goals with regulatory agencies.
  • Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions.
  • Must be familiar with pertinent FDA CFRs, FDA guidances, ICH guidelines, contractors and communication with Eudravigilance global regulatory, European clinical trial directives.
  • Experience in filing IND, SNDA, ANDA and/or NDA preferred.

TRAVEL REQUIREMENTS:

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

Discover 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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