Director, Study Evidence – Readiness

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $185.8k - $251.4k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Lead the Study Evidence and Readiness function, encompassing TMF Operations and Inspection Readiness • Set the strategy and priorities for TMF Operations and Inspection Readiness • Lead and develop global teams, including line management of Inspection Readiness Senior Managers and Managers • Set goals, manage performance and engagement, and build succession and capability plans • Provide integrated oversight of TMF health, critical evidence, inspection readiness, and material evidence gaps across the study portfolio • Establish metrics, thresholds, and escalation recommendations • Plan and manage departmental structure, capacity, resources, budget, suppliers, training, and business continuity • Lead improvement initiatives strengthening evidence quality, completeness, retrievability, and readiness • Represent the function in process improvement, standards development, and integration work • Develop and maintain TMF and inspection-readiness processes, policies, SOPs, work instructions, and related materials • Partner cross-functionally to resolve evidence issues, interpret trends, apply root-cause insights, and drive sustainable improvement • Provide leadership reporting on evidence health, readiness risks, remediation progress, and portfolio trends • Contribute to leadership forums and governance committees • Support audits and inspections, including preparation, response support, and lessons learned • Build relationships with internal and external experts

🎯 Requirements

• Doctorate degree & 4 years of directly related experience or equivalent OR Master’s degree & 8 years of directly related experience or equivalent OR Bachelor’s degree & 10 years of directly related experience or equivalent • 4 years of direct managerial and/or leadership experience or equivalent • PhD, PharmD, MSc, BSc, or RN qualification preferred • 11 years of work experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research at a biotechnology company, pharmaceutical company, or CRO preferred • Leadership experience managing direct reports, including management-level staff • Experience in TMF operations and inspection readiness, preparation, inspection support, or response • Experience managing or overseeing external clinical research vendors • Knowledge of global GCP and regulatory expectations for clinical trial conduct, TMF records, and inspection readiness • Knowledge of risk-based oversight, evidence health, resource planning, and organizational capacity • Experience leading cross-functional work in a matrix organization, including projects, budgets, timelines, and quality metrics • Ability to build relationships, lead change, develop high-performing teams, and communicate clearly • Sponsorship for this role is not guaranteed

🏖️ Benefits

• 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance • Financial plans with opportunities to save towards retirement or other goals

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume