Career CategoryClinical Development
Job DescriptionClinical Development DirectorWhat you will doLet'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 youWe 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 usAs 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 Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comApplication deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range274,788.85USD -371,773.15 USD
