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 Global Clinical Lead (Senior Medical Director)- GI & Immunology, in our Cambridge, MA office. We have a growing team on an exciting and high priority program.
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
- The Senior Medical Director will be the Rheumatology Global Clinical Lead (GCL) for the program.
- The Senior Medical Director leads and drives strategy for the overall rheumatology 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 is responsible 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. Applies clinical/medical decision making to clinical development issues.
Clinical Development team participation and leadership
- Leads the Rheumatology indications of a compound and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy.
- Establishes and drives the rheumatology aspects of compound strategy and deliverables producing the Development Strategy, 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 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.
- 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
- 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. 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. 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.
- 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
- Supports 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.
Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status scientific content matter expert for assigned indications of a compound. May represent clinical science on multidisciplinary task forces across divisions.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus 5 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).
- Experience with late stage clinical development
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
- NDA/MAA/Submission experience 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
- Emerging research in designated therapeutic area
- 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.
Location and Salary Information:
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range: $244, 300 to $349,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. 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.
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 at takedajobs.com.
No Phone Calls or Recruiters Please.
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.Locations
Boston, MAWorker Type