BioSpace

Senior Director, Translational Safety and Bioanalytical Sciences - PTR Team Leader Live. Our team's scope extends across Amgen's Therapeutic Areas, including Oncology, Inflammation, Rare Disease, and General Medicine/Cardiometabolic Disease, encompassing biosimilars programs and a wide array of modalities, such as small molecules, large molecules, and RNA therapeutics.. Expert knowledge of principles and theories in Biopharmaceutical Toxicology and Pharmacology and proficient knowledge of related and adjacent disciplinary areas such as Pharmacokinetics.. 15 years of drug development experience including interactions with global Health Authorities; must include late-stage assets and interactions with global regulatory agencies for IND/CTA and NDA/BLA/MAA filings and application of this experience to pipeline projects and platforms.. Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including

senior director

HOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Senior Director, Translational Safety and Bioanalytical Sciences - PTR Team LeaderLive What You Will Do Lets do this. Lets change the world. Amgens Translational Safety and Bioanalytical Sciences (TS&BA) function is actively seeking a Senior Director to join the Leadership Team overseeing the Portfolio Scientific Leadership (PSL) function. As a crucial member of the PSL Leadership Team, the Senior Director will play a strategic role in guiding the PSL Team, which consists of Project Team Representatives (PTRs) and Data Scientists. In this pivotal position, the Senior Director will provide overarching leadership for a group of PTRs within TS&BA, contributing to the seamless progression of projects from discovery through registration and life cycle management. Our team's scope extends across Amgen's Therapeutic Areas, including Oncology, Inflammation, Rare Disease, and General Medicine/Cardiometabolic Disease, encompassing biosimilars programs and a wide array of modalities, such as small molecules, large molecules, and RNA therapeutics. The Senior Director will contribute as a Senior Advisor on the TS&BA Portfolio Scientific Advisory Committee, act as delegate and advisor to the Executive Director US and EU Heads of PSL for key meetings (e.g., the TS&BA Portfolio Impact Meeting), represent TS&BA on R&D Initiatives, and actively contribute to the evolution of TS&BA to enable our rolling 3-year strategic vision. It is anticipated that the Senior Director will hold subject matter expertise and continue to develop as a subject matter expert (SME) in a particular area e.g., a toxicology specialty area, TA, or modality. The Senior Director will participate in external industry initiatives to improve drug safety assessment paradigms. As a people leader for TS&BA PTRs, you will further develop the scientific, drug development, and leadership skills of the team through coaching, identifying experiential learning opportunities, and ensuring individually tailored career developments plans are continuously evolved. In partnership with your team of PTRs, you will influence the development of fit-for-purpose translational safety strategies based on a strong scientific foundation, flexibly evolve the strategy in response to team goals and emerging data and encourage effective team behaviors. A strong understanding of the expertise and toolbox available at Amgen will be developed through networking to fully leverage our internal and external resources. It is expected that you will apply your toxicology, drug development, and regulatory experience to the novel targets and/or modalities in Amgens pipeline. The Senior Director will report to the Executive Director of TS&BA Portfolio Scientific Leadership (US) and is expected to periodically travel to Amgen R&D sites within the USA and EU. The Successful Candidate Will Have <ul><li>Organizational leadership experience including leadership of translational safety project team representatives, familiarity with leading global teams with cultural intelligence, and proven track record in people development, leadership of critical initiatives and leading within a dynamic organization.</li><li>Expert knowledge of principles and theories in Biopharmaceutical Toxicology and Pharmacology and proficient knowledge of related and adjacent disciplinary areas such as Pharmacokinetics.</li><li>In-depth knowledge of the functions and processes behind drug discovery and development, a strong understanding of cross-functional needs, and the ability to develop integrated plans to enable successful development of a therapeutic.</li><li>A track record of successful nonclinical safety submissions to global Health Authorities including weight-of-evidence assessments and briefing documents, and effective responses to regulatory questions.</li><li>Deep expertise in stages of development immediately preceding First-in-Human and continuing through clinical trials, registration, and life cycle management with a passion for biological understanding and application of biological insights to program success.</li><li>Experience developing therapeutics of various modalities, e.g., small and large molecules, including fit-for-purpose study designs and selection of nonclinical species.</li><li>Familiarity with ICH and Regional Regulatory guidance and working knowledge of GLP regulation and regulatory guidelines.</li><li>Prior work experience at, or collaborating with, contract research organizations.</li><li>Interest and ability to serve as a Subject Matter Expert in a specific area.</li><li>Excellent and professional verbal and written communication skills; proven ability to influence a broad spectrum of partners toward achieving business goals. </li></ul>Win What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 7 years of related experience Or Masters degree and 10 years of relate experience Or Bachelors degree and 12 years of related experience Preferred Qualifications <ul><li>15 years of drug development experience including interactions with global Health Authorities; must include late-stage assets and interactions with global regulatory agencies for IND/CTA and NDA/BLA/MAA filings and application of this experience to pipeline projects and platforms.</li><li>Experience with leading and mentoring a team of nonclinical safety project team representatives through both direct and matrix management.</li><li>Comfortable with setting and driving functional strategy and leading cross-functional teams through execution.</li><li>End-to-end small and large molecule safety assessment experience across multiple therapeutic areas and modalities, for example, small molecules, antibody drug conjugates and T-cell engagers.</li><li>Expertise in resolving biopharmaceutical safety-related issues.</li><li>Insights from contributing to cross-functional advisory or governance meetings within the Biopharma setting.</li><li>External visibility as a toxicology expert as demonstrated by a strong external presentation and publication record.</li><li>Diplomate of the American Board of Toxicology or another relevant certification, e.g., Diplomate, American College of Veterinary Pathologists (DACVP). </li></ul>Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including <ul><li>Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.</li><li>A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</li><li>Stock-based long-term incentives</li><li>Award-winning time-off plans and bi-annual company-wide shutdowns</li><li>Flexible work models, including remote work arrangements, where possible </li></ul>Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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