The PositionThe Associate Medical Director/Medical Director will be under the supervision of the head of cardiometabolic clinical development and will play a crucial role in introducing significant new therapies leveraging RNA interference to patients. This individual will collaborate closely with our client's scientific and clinical teams to advance drugs from late clinical research to NDA filings, with an initial emphasis on siRNA programs targeting cardiac and metabolic (lipids and obesity) indications. While experience in these fields is preferred, it is not mandatory. They will assume direct responsibility for designing and overseeing clinical studies to assess the efficacy, safety, dose selection, and clinical pharmacology of product candidates. Candidates with appropriate experience may be considered for the Medical Director position. Responsibilities Support the conceptualization, design, development, execution, and communication of clinical studies across various therapeutic areas. Serve as the medical lead in a cross-functional team comprising medical, scientific, clinical, safety, program management, and regulatory personnel. Effectively convey protocols and other pertinent information to clinical site investigators and staff. Interpret clinical trial data and communicate results clearly and accurately. Conduct ongoing clinical monitoring for trials, including assessing eligibility criteria, managing toxicity, and overseeing drug safety surveillance. Contribute to various documents, such as IRB submissions, protocols, study reports, publications, and regulatory filings, including forthcoming NDA/MAA submissions. Provide high-level and intricate scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management teams to ensure project deliverables and timelines are met. • Identify key opinion leaders and participate in clinical advisory board meetings. Deliver scientific presentations at advisory boards, major scientific gatherings, and external committee meetings. Identify and evaluate medical needs and clinical pathways for new applications of RNA interference in disease treatment. Stay abreast of emerging developments in RNA interference in both industry and academia. Support activities related to in-licensing, out-licensing, and partnership relationships.   Requirements: M.D., or Ph.D./M.D. combined with research experience A strong desire to contribute to the development of meaningful therapeutics Ability to effectively evaluate outside expert advice Ability to clearly elucidate complex scientific and medical concepts via written and oral communication Ability to work independently and effectively in a fast-paced, team-based, cross-functional environment Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings Excellent scientific communication skills (both verbal and technical) and interpersonal skills Possesses sense of urgency without overlooking key details; identifies challenges and problems and takes the initiative to identify solutions Results focused Willingness to relocate if necessary to either Pasadena or San Diego, CA Preferred: Hands-on clinical research experience within a pharmaceutical or biotechnology company or in an academic setting Fellowship training in relevant specialty (eg cardiology, endocrinology)  

Establish the regulatory pathway to IND filing in complex programs using a novel gene editing technology Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge of US and EU Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities Serve as a liaison between the company and regulatory agencies

Regulatory Affairs Manager - DACH (m/f/x) | Baden - Württemberg Area | Pharmaceutical Industry Are you a regulatory affairs specialist with a knack for navigating the intricacies of marketing authorizations within a global context? Do you excel in adhering to eCTD/eSubmission standards and thrive on contributing to regulatory strategy development? If you're seeking an opportunity to make a significant impact at a well-established medium-sized pharmaceutical company with international reach, your search ends here! Key Responsibilities: Taking care of all local RA activities and deliverables within the D-A-CH countries, including regulatory support for AAA Pharma.Fully responsible for DE/AT/CH exclusive licenses (i.e. maintenance, submissions, texts)Fully responsible for initial creation and maintenance of product information texts in German languageEvaluation and organization of new and updated product registration application dossiers related to the submission procedure, MAH transfers, renewals and variation procedures in DACHEvaluation of content and regulatory quality especially for the administrative documentation (Module 1)Responsible for the complete maintenance and lifecycle management activities of the exclusive licenses in DACHCollaboration with other teams/departments in regulatory affairs relevant projects and assessment of regulatory questionsReview, update, correction and submission of regulatory documentation after receiving the documents from the respective department for the exclusive licenses in DACHParticipation in regulatory affairs related projects regarding developing of new products and supporting TTs for the exclusive licenses in DACHConsistent updating of legislation requirements in DACH region.Excellent knowledge of the technical & regulatory requirements and experience regarding the registration & life cycle management (inter alia tech/site transfers, product information changes, product optimization etc.) of medicinal products with special focus on EU and the D-A-CH countries.At least a basic understanding for the regulatory requirements for food supplements in EU/D-A-CH.Negotiate approaches & responses to health authorities in a manner acceptable to both the regulatory agency and the company demonstrated by a proven track record of ensuring registrations / variations are successfully approved.Management, tracking and prioritization of daily business tasks. Qualifications:Bachelor's or master's degree in pharmacy, (veterinary) medicine, or related natural sciences.Preferably, a Master's in Drug Regulatory Affairs.3+ years of regulatory affairs experience in the pharmaceutical industry or food supplements sector.Strong understanding of registration and lifecycle management activities.Proven experience in negotiating and communicating with regulatory authorities.Proficiency in Regulatory Information Management Systems & Databases.Solid project management skills.Demonstrated reliability, teamwork, initiative, cross-functional collaboration, and multitasking abilities.Excellent written and verbal English; proficiency in German and other languages is advantageous.Benefits:Competitive salary package inclusive of base salary and 13th-month salary.Permanent employment contract.Generous annual leave entitlement of 30 days.Flexible part-time working arrangement (up to 25 hours per week).Convenient accessibility via public transport and ample parking availability.Flexible start date with the option for up to 40-60% remote work. Interested in this Opportunity? If you're eager to leverage your expertise in regulatory affairs within a dynamic pharmaceutical environment, we encourage you to submit your application today! We're also open to considering applications for alternative positions within our organization. My contact details: Email: revesz@sciproglobal.deTel: 0049 (0) 89/ 26 200 311 (direct dial) We eagerly await your application!

Overview A top mid-sized biopharma company out of the Boston area is hiring for a Director of Clinical Pharmacology. This position is can provide remote flexibility. This company is global biotechnology company with multiple commercialized drug products in the U.S and a great reputation in the space. This company operates in a few different therapeutic areas and requires a senior member to join their clinical pharmacology team and lead strategic decision making to develop their clinical pipeline. You will be acting as a SME in clinical pharmacology working with internal and external teams. You will be using the model informed drug development paradigm to facilitate drug development. As well as providing input to all applicable clinical development plans, protocols, and clinical study reports. You will work on regulatory submissions and represent Clinical Pharmacology at meetings with regulatory agencies. This individual will also help develop strategy to streamline processes in the Clinical Pharmacology group. What would you be doing? Serve as a Clinical Pharmacology SME for early development and late stage clinical projects. Provide guidance on lead modalities and programs to various teams working to determine the right target, molecule, dose, patient population and strategies. Apply knowledge in PKPD and relevant analysis (experience reviewing datasets in R or NONMEM is a plus) to strategize and predict exposure-response as well as dosing. Working closely with multiple different cross functional teams such as PMX to develop study protocols (Phase I – III). Advise on various regulatory documents (INDs, IBs, CDTs). Collaborate with various regulatory agencies (FDA, EMA, PMDA). Requirements: PhD required in pharmaceutical sciences, pharmacology, or related field At least 8+ years in the biotechnology or pharmaceutical industry Experience with clinical pharmacology and PKPD modeling, exposure-response or dose selection Experience with clinical PK data and data analysis (Phase I-IV) Experience in NONMEM and/or R (nice to have) Excellent communication skills