Executive Medical Director, Early Dev - Inflammation

Amgen • Thousand Oaks, CA

8d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Executive Medical Director, Early Development – Inflammation What you will do Amgen is advancing a broad/deep pipeline of Inflammation programs spanning multiple modalities. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients. Let’s do this. Let’s change the world. In this vital role the Executive Medical Director you will serve as an Early Development Inflammation Portfolio lead for key assets in the Amgen portfolio. You will serve as the principal representative for an early development portfolio to a range of audiences, including executive leadership, development partners, and global regulatory agencies. You will develop and translate Inflammation development program strategies into the design and implementation of clinical studies that can be executed without compromising scientific rigor. The Executive Medical Director will report into the Associate Vice President, Early Development.

Requirements

• 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

Nice To Haves

• 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
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Understanding of resource and budgeting

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree