Executive Medical Director Clinical Development Endocrinology, Europe

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: The Executive Medical Director, Europe is responsible for providing medical oversight of clinical programs in the endocrinology therapeutic area, including marketed products and investigational medications. The Executive Medical Director will help lead the strategy, planning, and execution of the clinical development plan, including Phase 1 to 4 clinical studies in collaboration with cross-functional project team members, including clinical operations, clinical pharmacology, biometrics, regulatory, drug safety/pharmacovigilance. The Executive Medical Director will also partner with medical affairs, HEOR, and commercial to provide guidance on publication strategy, data generation needs, and label expansion opportunities for marketed products._ Your Contributions (include, but are not limited to): Oversight of the clinical development strategy in the endocrinology therapeutic area Oversight of the design of clinical trials across early to late-stage development to ensure they meet regulatory requirements and scientific standards Lead the writing of protocols and major amendments, design of data collection systems, and preparation of clinical study reports, engaging with external experts as needed Collaboration with Clinical Operations to ensure trials are implemented in accordance with Neurocrine SOPs, good clinical practice, and applicable regulations Monitoring patient safety and the overall benefit-risk profile of investigational drugs throughout the clinical trials in collaboration with Drug Safety and Pharmacovigilance Leads analysis, interpretation, and presentation of clinical trial data to internal and external audiences e.g. decision making, regulatory submissions, and scientific disclosures including conference abstracts and publication of manuscripts Engage with and foster strong relationships with key opinion leaders and investigators to incorporate clinical insights into internal strategy and ensure optimal clinical trial execution Collaborate closely with Medical Affairs, HEOR, and Commercial to support marketed products through publication of data and identification of evidence generation needs Adhere to Neurocrine Europe quality assurance system and compliance with the relevant SOPs Requirements: The appointed candidate will be a physician with specialist experience/qualifications in endocrinology and/or a proven track record of clinical development in endocrinology products. MD qualified, ideally with specialist medical qualification in Endocrinology and previous experience in patient care At least 8 years experience in early or late stage clinical development in the pharmaceutical industry, ideally including experience with development of endocrinology products Excellent understanding of clinical trial design, execution, and regulatory requirements, including experience with regulatory agencies in the US and UK/Europe Excellent communication and presentation skills, with the ability to effectively convey complex scientific information to internal and external stakeholders Strong analytical and problem-solving abilities, with a strategic mindset Excellent interpersonal skills, with the ability to engage and collaborate with a range of audiences, stakeholders and partners Demonstrated leadership skills with the ability to influence across cross-functional teams Excellent organisational and planning skills Ability to work in a fast-paced, dynamic environment and manage multiple priorities effectively Flexibility in working hours, including willingness to accommodate some US business hours Demonstrates high motivation and a strong desire to achieve results and positive patient outcomes Requirements: Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.