Description
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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?
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 deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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 study that will result in the regulatory approval of the compound in multiple regions. This individual interacts with and strongly influences GPT 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 GPT 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. Support to 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 study documents 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 the assigned clinical study with high degree of accountability. Identifies, develops, recommends and/or negotiates novel (but scientifically sound) solutions to meet critical business needs.. 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. Provides clinical input to go/no go decisions of assigned studies. 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, study teams
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor's in Science, professional license and at least 15 years of 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 in science preferred and at least 13 years of 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 12 years of 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 10 years of 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 Ph.D. with suitable experience At least 2 years of experience in designing and running clinical trials. pharmaceutical industry experience is preferred. 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. Familiar with pertinent FDA CFRs, FDA guidance's, ICH guidelines, contactors and communication with Eudravigilance global regulatory, European clinical trial directives is preferred 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 5 % 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
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
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EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran..... click apply for full job details
