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 Head, GPSE Medical Center of Excellence for Target Organ Toxicity & Other Important Safety Information in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Head, GPSE Medical Center of Excellence for Target Organ Toxicity & Other Important Safety Information working on the Medical Safety Oncology team, you will be empowered to Innovate and Strategize. A typical day will include:
This newly established role within Global Patient Safety Evaluation (GPSE) is critical in our commitment to rigorous medicine and science, with patient safety at the core of expertise. This role will:
- Establish and execute a strategy to build a Center of Excellence (CoE) to provide scientific expertise on the identification, characterization and monitoring of drug-induced tissue and organ toxicity and other adverse effects that can have significant impact on patients.
- Provide the strategic and operational support to develop and maintain a consistent and proactive pharmacovigilance and safety management approach to target organ toxicity across all therapeutic areas.
Oversee and manage Other Important Safety Information (OISI) that may influence the benefit-risk profile of Takeda s marketed and investigational compounds, and contribute relevant tissue and organ toxicity expertise to Health Hazard Evaluations as needed.
By working closely with colleagues within GPSE and stakeholders across our Therapeutic Area Units and Drug Discovery Units, this individual is principally accountable for driving the GPSE strategic roadmap of internal and external partnerships for target organ toxicity. To achieve this goal, the individual is expected to:
- Provide strategic and expert scientific input on identification, characterization and monitoring of vital organ toxicity and other events that may require special attention based on accumulated compound knowledge.
- Lead the development and implementation of innovative and patient-focused strategies to support medical and scientific safety excellence in tissue and target organ toxicity, including facilitating specialist organ toxicity advice to Takeda project teams seeking guidance.
- Identify and engage, as needed, a network of clinical experts with experience in clinical trials and event review/adjudication across numerous therapeutic areas, including cardiovascular studies, respiratory medicine, infectious diseases, gastrointestinal and liver disease, kidney disease, and pediatrics.
- Provide strategic input and operational support for appropriate categorization and interpretation (adjudication) of adverse events of possible tissue or organ toxicity.
- Assist in the development and maintenance of a portfolio of tools for application across a wide range of safety data to assist with the identification and characterization of tissue/target organ toxicity including underlying factors and etiologies that may impact or cause drug-induced tissue or organ toxicity.
- Integrate structured safety assessment for tissue/organ toxicity into clinical trial and post-marketing pharmacovigilance activities, including accepted diagnostic standards, monitoring criteria and surveillance approaches.
- Contribute to improved understanding and prevention of organ toxicity issues across the company, which may include presentation of case studies, lessons learned, sharing of best practices, and hosting guest speakers.
- Provide support, as needed, for discussions with international regulatory bodies.
- Foster a continuous learning environment by identifying and addressing new trends and incorporating new methodologies in tissue and target organ toxicity prediction.
Oversee the collection, evaluation and management of OISI and maintain the operational process frameworks for collection of OISI, including driving process improvement and change management in concurrence with company-wide and functional plans.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILL:
- Advanced medical, scientific or life sciences degree (MD, PhD, PharmD, DVM or internationally recognized equivalent).
- 6+ years experience in pharmacovigilance, clinical or translational research, or clinical development within pharmaceutical industry or academia.
- Sound understanding of drug-induced tissue and target organ toxicities, including pharmacologic mechanisms and scientific methodologies and best practices that can be applied for proactive risk identification and management.
- Proven ability to navigate a matrix organization with experience in influencing across multiple areas without direct authority and developing and maintaining key relationships across a broad sphere of influence.
- Proven ability to work globally and cross-functionally, with excellent interpersonal skills and the ability to understand multiple, complex business needs and identify ways in which existing or newly designed solutions could address these in an effective and efficient manner.
- Ability to engage with independent subject matter experts to understand and apply accepted diagnostic standards, monitoring criteria and surveillance approaches for target organ toxicity.
- Knowledge of regulatory authority requirements regarding drug safety and an understanding of general drug safety methodologies.
- Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.
- Ability to work productively in a fast paced and pressured environment.
- Self-resourced, with confidence to take initiative and act autonomously.
- Able to facilitate and efficiently lead meetings, both in person and via other media.
- Excellent oral and presentational communication skillset.
- Estimated 5-10 times per year including international 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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.