Senior Medical Director, Cold to Hot

Company: Takeda
Location: Boston
Posted on: March 20, 2023

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre 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.OBJECTIVES:The Senior Medical Director leads and 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 ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan of assigned compound(s) in multiple regions as well as inform the value drivers required for reimbursement. Applies clinical/medical decision pertaining 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.ACCOUNTABILITIES:Clinical Development team participation and leadership with focus on the Cold to Hot platform. Leads Global (US/EU/Japan) Clinical Sub-Team and oversees Japan & Asia Clinical Sub-Team to ensure that activities are aligned with the global strategy. As a member of the Global Program Team (GPT), establishes and drives Clinical Sub-Team strategy and deliverables in the context of the GPT's Asset Strategy; leads the generation of the Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the Asset 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.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 and more junior medical directors involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine 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 medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety, in partnership with CRO responsible for trial delivery. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees medical and 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. 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 partner 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 based on 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. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.Coordinate, lead and deliver periodic departmental trainings.EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• MD or internationally recognized equivalent, plus 5 years of clinical research experience within the pharmaceutical industry, or relevant biomedical/clinical experience within academia.
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
• Oncology training (fellowship or internationally recognized equivalent) preferred.
• Experience working with early stage oncology assets preferred.
• Management experience
• 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
• Therapeutic area knowledge relevant to mechanism of action
• Regional/global Regulatory requirements
• GCP/ICH
• Emerging research in designated therapeutic areaTRAVEL 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 - 25% travel.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.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 ProgramsBase Salary Range: 238,000 to 341,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.#LI-JT1EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda, Boston , Senior Medical Director, Cold to Hot, Executive , Boston, Massachusetts