Senior Medical Director, Pharmacovigilance, GI²

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Medical Director, Pharmacovigilance, GI² where you will have oversight of medical safety activities and processes for the allocated Therapeutic Area by ensuring the continuous assessment of the safety profile and of the benefit-risk of investigational compounds and marketed product.

You will provide strategic and Patient-focused leadership and vision for further development of medical safety TA in support of asset strategy. You will strengthen Patient focused medical and scientific excellence/innovation. You will also timely escalate safety issues to the Chair of Takeda Safety and Board as required. You will define and implement a functional vision for Patient Safety, further advance robust and innovative medical safety capabilities on level-setting business processes with leading industry standards and be a core member of company-wide Committees and Governance.

As part of the Global Patient Safety & Evaluation (GPSE) team, you will report to the Executive Medical Director, Head, of Global Medical Safety, GI Therapeutic Area Unit (Inflammation), Global Patient Safety & Evaluation where you may be responsible for the management/oversight of physicians and Health Care Professionals (HCPs) who serve as the Global Safety Leaders (GSL) and PV Scientists for both developmental and marketed compounds in the designated therapeutic area and may act as a GSL.

How you will contribute:

• Depending on resource allocations, may directly manage a group of GSLs and PV Scientists responsible for overseeing the medical safety profile for assigned products.
• Interacts with and influences colleagues from other functions to ensure the successful development, design and implementation of comprehensive safety and benefit-risk assessment strategies for products.
• Oversees signal detection and risk management activities for assigned products and ensures that development plans include comprehensive safety assessment plans.
• Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs
• Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned GI compounds and products.
• Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders.
• Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Leads the interpretation of safety data from internal and external sources, assessment of ensuing scientific and medical implications, and communication of the impact of same both in terms of “go/no go” decisions or modification of development plan or study design, including potential impact on timeline or product labeling, ensuring the primacy of patient safety.
• Mentors GSLs and PV Scientists with respect to compounds in development and marketed drugs, safety monitoring and risk management assessment and analysis.
• Supports cross-functional team evaluations in preparation for presentations to the Takeda Safety Board and similar forums. The Senior Medical Director will be a key player in the preparation and presentation of materials to the Takeda Safety Board and similar forums.
• Manages the reactive response to emerging safety signals.
• May perform the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).
• Ensures high quality analyses of safety information, in support of safety update regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide.
• Assists the Global Medical Safety GI Therapeutic Area Head in assessing the implications of emerging regulatory intelligence and developing strategies for adapting processes and procedures.
• Oversees risk management plans for compounds in development and marketed drugs.
• Ensures that GSLs are proactively identifying safety concerns and developing contingency strategies that address these challenges.
• Maintains professional knowledge and accreditation by active participation in continuing medical education activities, and fosters a community of continual learning.

Minimum Requirements/Qualifications:

• Medical Degree (MD) required or internationally recognized equivalent ideally combined with Advanced Degree.
• 8 years+ of experience gained in Pharmacovigilance, Clinical Research, or Clinical Development within the Pharmaceutical industry and/or academia and/or CRO including significant experience in operating in a global pharmacovigilance organization.
• Minimum of 3 years of experience in people management.
• Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug safety methodologies.
• Ability to comprehend and synthesize complex data and should have experience in the identification, analysis, and implementation of programs and procedures required to achieve corporate objectives.
• Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.
• Identifies opportunities and anticipates changes in the medical safety. landscape through an understanding and ongoing assessment of the environment affecting the Patient.
• Must have demonstrable experience in people management at a leadership level and well-developed skills in team building, motivating, empowering, and developing people.
• Work productively in a fast-moving and pressured environment.
  • Good analytical/judgment capabilities to understand,analyze/synthesize and communicate successfully and concisely
  • Well-developed time management skillset to assist in prioritization of multiple issues
  • Computer literate, including safety database acumen
  • Self-resourced, with the confidence to take the initiative and act autonomously
  • Both facilitate and efficiently lead meetings, both in person and in other media
  • Excellent communication skillset, orally and presentational
• Proven ability to work globally and cross-functionally, with strong interpersonal skills /appropriately assertive /team-minded and mentoring.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• 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 and a company match of charitable contributions
• Family Planning Support, Family Leave
• Flexible Work Paths
• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: Senior Medical Director - $238,000 to $341,000, based on the candidate's 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.

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.

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

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time