Medical Director, Clinical Research, Endocrinology

🕒 il y a 2 mois

🏄 California – Distant

🏄 California – Remote

💵 $270 000 - $298 000 / an

⏰ Temps Plein

🔴 Expert

👨‍⚕️ Directeur Médical

👻 Score fantôme 7%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Crinetics Pharmaceuticals

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2015

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Crinetics Pharmaceuticals est une entreprise de biotechnologie qui développe des thérapies innovantes pour les maladies endocriniennes. L'entreprise se concentre sur le traitement des besoins médicaux non satisfaits en créant des traitements pour des affections telles que l'acromégalie, le syndrome carcinoïde, le syndrome de Cushing ACTH-dépendant, l'hyperplasie surrénale congénitale, et d'autres troubles endocriniens. Crinetics s'engage à améliorer la qualité de vie des patients grâce à une science de pointe et des essais cliniques robustes. Leur portefeuille comprend des candidats prometteurs comme le paltusotine, qui a été accepté par la Food and Drug Administration des États-Unis pour le traitement des patients adultes atteints d'acromégalie. L'entreprise collabore avec des praticiens de santé et des parties prenantes pour s'assurer que leurs thérapies répondent efficacement aux problèmes réels et construisent de la valeur pour les investisseurs en entrant dans des niches de marché avec des besoins significatifs.

Description

• Support the development and execution of Crinetics' endocrinology portfolio as part of a multidisciplinary development team • Contribute to the concise clinical development plan (CCDP) • Support the design and conduct of clinical trials across assigned therapeutic areas • Provide medical and scientific input to publications • Support Medical Affairs • Help represent Crinetics to academic, regulatory, and patient organizations • Partner with the cross-functional team to shape a concise Clinical Development Plan (CCDP) for the indication of interest, building consensus toward Executive Team approval and maintaining the plan over time • Lead the design, planning and implementation of clinical trials consistent with this CCDP • Provide scientific and clinical direction for the development of clinical protocols (and, in early stages, clinical trial outlines [CTOs] and synopses), amendments, and related documents (e.g., informed consent) • Work with Medical Writing to ensure content accuracy and medical integrity • Provide medical monitoring for clinical studies in collaboration with CRO medical monitors • Ensure that clinical trials are conducted according to GCP and all applicable regulatory requirements • Provide clinical and scientific input to HEOR-led Patient Reported Outcome research across the studies • Provide medical and scientific oversight needed to support enrollment feasibility and protocol-driven eligibility • Participate in ongoing and formal data analyses and review for CSR completion and planned/actual filing activities • Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions • Lead trial-related advisory boards, investigator meetings, protocol training meetings • Collaborate with Medical Affairs and Commercial members to develop effective working relationships with key investigators, key opinion leaders and patient advocates to optimize scientific quality/innovation of clinical study design, execution, reporting and publication • Provide medical/clinical expertise to publications planning and drafting • Provide oversight of clinical programs across planning, execution, and completion of clinical trials, ensuring compliance with all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs, in partnership with Clinical Operations • Attend conferences and remain current with relevant therapeutic area information • Serve as the external clinical "face" of Crinetics in interactions with development partners, and leading clinical discussions at advisory boards, as needed.

🎯 Exigences

• MD degree with at least 5+ years clinical research experience within industry or academia • Endocrinology subspecialty board certification preferred • Thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines (e.g., biostatistics, data management, medical writing) • Deep understanding of strategic and operational aspects of clinical research and product development • Solid understanding of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development • Familiarity with regulatory agency interactions (FDA and/or EU), whether through direct participation or supporting submission activities • Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives) • Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment • Superior interpersonal skills focusing on collaboration and influencing capabilities supported by great presentation skills • Strategic thinker, team leader and individual contributor capable of working in a high growth, dynamic, science-driven environment • Ability to conceive and execute innovative approaches to clinical development while taking into account the safety and the comfort of the patient • Can also take the role of a self-starter individual contributor, who enjoys rolling up their sleeves and digging into the details; rigorous attention to details and data, while not losing sight of the bigger picture and remaining flexible • Collaborative, effective leadership skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within and external to the organization • Ability to inspire and earn respect of the leadership team, Board members, the regulatory authorities, the investment community, colleagues, and staff • Respectful of the ideas and experience of all members of the Crinetics team • Ethical, with highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders.

🏖️ Avantages

• Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown • Discretionary annual target bonus • Stock options • 401k match