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Medical Director/Senior Medical Director, Clinical Science, Gastrointestinal and Inflammation Therapeutic Area

Cambridge, Massachusetts
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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job ID R0112249 Date posted 11/30/2023 Location Cambridge, Massachusetts

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Job Description

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 Medical Director- GI & Immunology, in our Cambridge, MA office to join a growing team on a high priority molecule.

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 Medical Director (or Senior Medical Director) will lead new indication development for the program and ultimately execute clinical trials in the indications chosen.
  • This role leads and drives strategy for new indications taking into consideration the medical, scientific, regulatory and commercial issues for the assigned Takeda compound.
  • 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 for new indication that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues.

ACCOUNTABILITIES:

  • Clinical Development team participation and leadership
    • Represents Clinical Science on the new indications cross functional team.
    • Establishes and drives 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.
  • 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.

  • Leadership, Task Force Participation, Upper Management Accountability
    • Interacts directly with cross functional groups 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.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • MD or internationally recognized equivalent plus 2 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 creating clinical development plans and clinical trial design in autoimmune/inflammation diseases
  • Previous experience successfully working in a clinical development team/matrix team with responsibility for studies in multiple regions.

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

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 - 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: $217,000 to $310,000, 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

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.

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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, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Cambridge

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Alison Handley, Head, Center for External Innovation

During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.

Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations

When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.

Meredith Culp - GPM Head & Chief of Staff, Neuroscience Therapeutic Area

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Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

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Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

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About our location

Cambridge, Massachusetts


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