Principal Clinical Development Specialist

Summary Posted: Dec 4, 2023 Weekly Hours: 40 Role Number: 200372293 As part of the Clinical Team, Apple is looking for an individual who will partner with Apple Engineers, Clinicians, Clinical Operations, and Regulatory team members across the company to design, develop and implement clinical study strategies to support our Health features. Key Qualifications Key Qualifications PhD, MD, and/or extensive experience in industry clinical research. Familiarity with diagnostics, aids-to-diagnosis, or triage tools. Experience with adaptive, and decentralized, clinical studies in the medical device or diagnostics space Innovative thinker open to novel approaches in trial design, including innovative considerations in study design (ex: e-consenting, digital biomarkers, interim analyses) Experience with studies for regulatory decision-making Partner closely with Clinical team members in designing and executing the clinical study Description Description Candidates must possess deep subject matter expertise in large-scale, and small-scale, studies including experience in the medical device and/or pharmaceutical regulatory process. The ideal candidate will have a strong desire to build innovative consumer-focused features, is effective at executing detailed deliverables on time, is capable of working closely with cross-functional teams, engages well in open discussion and debate, and is not afraid of a challenge. • Lead and author clinical study documentation including target product profiles, clinical study synopses and protocols, and other support for regulatory filings • Dive into details of targeted claims, and specify relevant clinical validation design feasibility and complexity. • Provide clinical input, contribute to statistical analyses plans, protocols, pre-submission documents, and coordinate clinical study reports. • Provide clinical leadership based on portfolio direction. • Partner closely with multi-disciplinary teams including Engineers, Clinicians, Clinical Operations, and Regulatory. • Provide input on best practices in different therapeutic areas re: gold standard endpoints and outcome measures, scientific/ clinical validity evaluations, study instruments and questionnaires, and the relevant standards for evaluating medical devices • Communicate effectively with a diverse group of internal and external partners. • Anticipate, adjust for, and communicate problems, risks, and roadblocks. Education & Experience Education & Experience PhD, MD, and/or extensive experience in industry clinical research Additional Requirements Additional Requirements • Excellent communication and interpersonal skills. • Experience writing clinical protocols and clinical study reports, in the US and globally • Ability to simplify complex concepts and communicate these to non-clinical team members. • Independent self-starter who thrives in complex and ambiguous environments. • This is a site based role Pay & Benefits Pay & Benefits At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $188,000 and $282,500, and your base pay will depend on your skills, qualifications, experience, and location. Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses — including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits. Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.