Executive Medical Director, Early Dev - Inflammation

Responsibilities

• Develop an Early Development Inflammation team in collaboration with the Early Development Therapeutic Area Head
• Ensure the best way to develop and prosecute an early development portfolio
• Drive the timely execution of multiple assets and studies within the early development portfolio
• Ensure strategy and execution, and partner closely with Research, Translational Safety (toxicology), Precision Medicine, Clinical Pharmacology, Biostatistics, and Clinical Operations colleagues
• Partner closely with Regulatory leaders to support regulatory interactions and develop regulatory strategies
• Keep major stakeholders and other senior management updated as the portfolio evolves and matures
• Guide their team to think broadly as they create innovative portfolio development strategy options
• Ensure all avenues and options have been explored and evaluated before final recommendations are sent for review by senior leadership
• Oversee activities related to planning for studies, including execution and oversight of study outlines and Protocols for early development clinical studies
• Collaborate with Business Development colleagues in the evaluation of external opportunities
• Mentor, coach, and supervise the performance of direct reports to build a highly skilled, diverse, and inclusive team, leading and motivating staff in a complex, multi-functional matrix environment

Qualifications

• MD or DO from an accredited medical school
• Five (5) years of industry or academic research
• Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Preferred qualifications include:
• MD or MD/PhD plus accredited residency in relevant sub-specialty, board certified or equivalent
• Relevant subspecialty board eligibility/certification or equivalent
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• Proven success record in how to conceptualize, design, conduct, and analyze early development clinical trials
• Ability to anticipate problems and find creative solutions
• In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints
• A record of high-quality peer-reviewed publications
• Experience functioning as a medical expert in a complex matrixed environment
• Previous experience in conducting translational and/or clinical research for both small molecules and large molecules
• History of solving problems while exhibiting judgment and a balanced, realistic understanding of issues including the ability to anticipate problems and find creative solutions
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Knowledgeable in current and possible future trends, technology, policies, practices, and information of the competitive landscape of oncology development and global health authority requirements for oncology drug approval
• Understanding of resource and budgeting

What We Expect Of You

• Be an experienced leader with the following qualifications:
• Basic Qualifications
• MD or DO from an accredited medical school
• Five (5) years of industry or academic research
• Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Preferred Qualifications
• MD or MD/PhD plus accredited residency in relevant sub-specialty, board certified or equivalent
• Relevant subspecialty board eligibility/certification or equivalent
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• Proven success record in how to conceptualize, design, conduct, and analyze early development clinical trials
• Ability to anticipate problems and find creative solutions
• In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints
• A record of high-quality peer-reviewed publications
• Experience functioning as a medical expert in a complex matrixed environment
• Previous experience in conducting translational and/or clinical research for both small molecules and large molecules
• History of solving problems while exhibiting judgment and a balanced, realistic understanding of issues including the ability to anticipate problems and find creative solutions
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Knowledgeable in current and possible future trends, technology, policies, practices, and information of the competitive landscape of oncology development and global health authority requirements for oncology drug approval
• Understanding of resource and budgeting

Pay & Benefits

• The expected annual salary range for this role in the U.S. is $333,957- $451,824.
• Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
• In addition to the base salary, Amgen offers a total rewards plan, based on eligibility, comprising of 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 that may include 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.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models where possible.