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/PURPOSE
The Senior Medical Director drives strategy for the overall global (US/EU/Japan) clinical development, taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. 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 global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions as well as inform the value dossiers required for reimbursement. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences Oncology Therapeutic Area Unit and Takeda R&D senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of Takeda R&D to meet its corporate goals and for Takeda to have future commercial products. May serve as Global Clinical Leader of individual therapeutic programs
ACCOUNTABILITIES .
Clinical Development team participation and leadership
Focus on hematological malignancies and solid tumor platforms. Develops Clinical Sub-Team strategy and deliverables in the context of the GPT's Asset Strategy; works collaboratively to generate the Clinical Development Plan and Clinical Protocols. Responsible for high impact 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. A significant error in judgment may result in loss of approvability and commercial viability of a product. Synopsis / Protocol Development, Study Execution, & Study Interpretation
Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities and is accountable for the successful design and interpretation of clinical studies. 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 performing or overseeing medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety, in partnership with the CRO responsible for trial delivery. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues. Makes final decisions regarding study conduct related to scientific integrity. External Interactions
Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or 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. Works with Medical Affairs in interactions with investigator-initiated clinical studies. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; 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, conduct 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. Serves as clinical contact point for ongoing alliance projects and interface with partners to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner. Leadership, Task Force Participation, Upper Management Accountability
Interacts directly with Oncology DDU and Oncology Business Unit using pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as OTAU scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions. Lead Takeda R&D internal teams and may lead global cross-functional teams, as appropriate. Manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. Coordinates, leads and delivers periodic departmental trainings. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
MD degree, 15+ year related work experience Sufficient grounding in the principles of the scientific method and cancer biology and experience in oncology drug development and regulatory sciences sufficient to lead internal and external projects relevant to the Oncology TAU across the spectrum of R & D (early and late phase, LCM). Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Global experience preferred. NDA/MAA/Submission experience 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 Effective leadership behavior Knowledge
Therapeutic area knowledge relevant to mechanism of action Regional/global Regulatory requirements GCP/ICH Emerging research in designated therapeutic area 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% 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.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Base Salary Range: $ Range Min to $ Range Mid..... click apply for full job details
