Senior Medical Director, Gastrointestinal and Inflammation

Job not on LinkedIn

October 10

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $257.6k - $404.8k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI²). • Oversee medical safety activities and processes for assigned products, ensuring continuous assessment of safety profiles and benefit-risk of investigational and marketed compounds. • Provide strategic, patient-focused leadership for medical safety, support asset strategies, and strengthen medical and scientific innovation. • Timely escalation of safety issues to the Takeda Safety Board Chair is required. • Define and implement a vision for Patient Safety, enhance medical safety capabilities, and be a core member of company-wide Committees and Governance. • May manage/oversee physicians and Health Care Professionals (HCPs) serving as Global Safety Leaders (GSL) and PV Scientists for a compound that is both in clinical development and marketed in the designated therapeutic area. • Oversees signal detection and risk management activities for assigned products and ensures that development plans include comprehensive safety assessment plans. • Leads PSPV 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. • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• U.S. based employees may be eligible for short-term and/ or long-term incentives. • U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. • U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.