Clinical Development Director, Early Development – Inflammation/Rare Disease

Clinical Development Director, Early Development – Inflammation/Rare Disease

What you will do

Let’s do this. Let’s change the world. In this vital role, you will lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept. You will collaborate on teams to support the design and delivery of early phase clinical trials. Through this role, the Clinical Medical Director will support protocol and IND development, study start up, data review, monitoring and analysis activities.

Responsibilities

• Contribute to the design and implementation of the early clinical development strategy for Inflammation, General Medicine or Rare Disease therapeutic candidates

• Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions

• Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data

• Contribute to the strategy and use of clinical biomarkers to facilitate drug development

• Actively collaborate with Amgen Precision Medicine, Research, Clinical Pharmacology, Operations, Late Development, Regulatory, Safety and Commercial colleagues

• Contribute to the evaluation of external licensing or partnering opportunities within the cardiometabolic/general medicine therapeutic areas

• Collaborate with external experts to provide biomedical expertise and strategic guidance to Early Development teams

• What we expect of you

• We are all different, yet we all use our unique contributions to serve patients. The Early Development professional we seek is a Leader with these qualifications.

Basic Qualifications:

• MD or DO degree from an accredited medical school AND

• 2 years of industry or academic/basic sciences/clinical development experience

Preferred Qualifications:

• Board certification or eligible (Internal Medicine, relevant subspecialty)

• Residency training in Internal Medicine and relevant subspecialty

• Understanding of pathophysiology of inflammatory, general medicine, and/or rare diseases

• Experience in basic research and/or clinical trial methodology

• 3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials

• Experience collaborating with pharmaceutical sponsors

• Experience in designing, monitoring and implementing clinical trials and interpreting trial results

• Demonstrated leadership qualities; capable of conducting studies as part of a team

• Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines

• Publication track record

• Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators

• What you can expect of us

• As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• 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.

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:

• A 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
• Flexible work models where possible. Refer to the Work