Recordati

The Scientific Director, US Medical Affairs, Endocrinology will serve as a scientific/medical expert to lead and manage strategic initiatives and projects that integrate Recordati’s scientific, clinical data into programs that drive business and medical affairs priorities.. In this multifaceted role, the incumbent will provide expert medical and scientific support across the US Endocrinology franchise including formulating US Lifecycle Management for the US franchise including management of Real-World Evidence studies, Investigator-Sponsored Studies (ISS) and any US-based study for the Endocrinology therapeutic area.. Facilitate team review and justification for approval of external independent CME (continuing medical education) grant requests to assure compliance with legal and regulatory demands. In coordination with the CMO and other heads of Medical Affairs, develop and implement strategy and tactics for an integrated US Medical Plan for Endocrinology (Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB/Phase IV and investigator-sponsored studies (ISS. Collaborate with Global teams on health economics and outcomes research (HEOR) to establish scientific clinical credibility with payers and healthcare decision makers

scientific director

ID: 674 Date of Posting: May 9, 2024 Job Family: Medical Job Type: Direct Employee On site / Remote / Hybrid: Remote Location: Bridgewater, NJ, US Territory Shift: Full Time Seniority: Director With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life. Reporting Structure Reports to: CMO / Vice President, Medical Affairs and Clinical Development, RRD North America Manages: Number of current direct reports: 2 and will expand in the near future Therapeutic Area: Endocrinology Overview The Scientific Director, US Medical Affairs, Endocrinology will serve as a scientific/medical expert to lead and manage strategic initiatives and projects that integrate Recordati’s scientific, clinical data into programs that drive business and medical affairs priorities. In this multifaceted role, the incumbent will provide expert medical and scientific support across the US Endocrinology franchise including formulating US Lifecycle Management for the US franchise including management of Real-World Evidence studies, Investigator-Sponsored Studies (ISS) and any US-based study for the Endocrinology therapeutic area. The Medical Director will help prepare US RRD Medical Affairs for current and future business needs and innovation. Essential Duties And Responsibilities <ul><li> Strategic and operational input into core medical affairs activities such as healthcare professional interactions, data generation and educational initiatives.</li><li> Provide strategic direction and oversight of all US Medical Affairs in designated therapeutic area and activities related to Scientific Communication, Medical Education, and Key Opinion Leader (KOL) engagement</li><li> Facilitate team review and justification for approval of external independent CME (continuing medical education) grant requests to assure compliance with legal and regulatory demands</li><li> Position RRD as a thought leader in designated therapeutic area, with a focus on KOLs within the disease states of interest in the therapeutic area</li><li> Lead medical and scientific advisory boards to capture insights, incorporating actionable insights into the medical strategy and plan</li><li> Maintain expertise of current disease and competitive landscape through participation in medical congresses, professional association meetings, and other national and local events</li><li> Establish and maintain relationships with Key Opinion Leaders (KOLs) in the therapeutic area to establish strong scientific presence in the practicing and academic communities</li><li> Collaborate with Regulatory and Pharmacovigilance to ensure accurate product labeling and appropriate communication of safety-related information</li><li> Function as key strategic partner and scientific/medical counsel to the RRD Commercial/Marketing, Pharmacovigilance, Medical Information, Regulatory, and Legal functions.</li><li> Represent medical affairs for the medical review process</li><li> Serve as the subject matter expert to support the Medical Information Director with FAQ development</li><li> Participate in the development and review of slide presentations, medical letters, clinical summaries, and sales materials</li><li> Review all materials intended for submission for publication</li><li> Provide input into key regulatory promotional documents/materials meant for promotion</li><li> Provide input to AMCP (Academy of Managed Care Pharmacy) and other reimbursement documents with the purpose to support formulary decisions</li><li> Ensure that the training of internal medical teams and/or sales professionals is accurate and balanced to communicate complete data about disease states and products within RRD therapeutic areas</li><li> Maintain compliance with all internal and external legal and regulatory guidelines</li><li> Provide Endocrinology medical expertise for Clinical Development/Trials and FDA approvals</li><li> In coordination with the CMO and other heads of Medical Affairs, develop and implement strategy and tactics for an integrated US Medical Plan for Endocrinology (Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB/Phase IV and investigator-sponsored studies (ISS))) and annual applicable budget across Endocrinology pipeline</li><li> In conjunction with RRD Global R&D, assist in design and supervision of clinical trials in the US for mid to late-phase development and Phase IIIB-IV programs</li><li> Determine the needs, develop, and execute strategic plans for post-marketing studies</li><li> Assist in preparation and review of regulatory submission documents for new products or formulations</li><li> Represent RRD in label negotiations with FDA</li><li> Provide strategic medical practice input to the product development teams to ensure that appropriate studies are planned and executed to provide practice relevant data on the marketed products. Evaluate proposed research concepts and protocols for IIS, assessing such studies for medical/scientific merit, appropriate design and strategic fit for the product</li><li> Interpret clinical data to determine the potential impact of new research on medical thinking and practice</li><li> Collaborate with Global teams on health economics and outcomes research (HEOR) to establish scientific clinical credibility with payers and healthcare decision makers</li><li> In collaboration with the head of field medical affairs, responsible for the development of the medical section of the therapeutic area commercial brand plan</li><li> Provide inspirational leadership to the team by cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities, while attracting, developing and retaining top talent</li><li> Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.</li><li> Perform additional duties as may be assigned. </li></ul>Education And Experience <ul><li> Medical Degree (MD or DO) from accredited US or foreign medical school or university required</li><li> Strong general knowledge of rare diseases required</li><li> At least 15+ years of experience in Endocrinology Medical Affairs with a pharmaceutical company and/or clinical practice</li><li> Working knowledge of all areas of Endocrinology product lifecycle including pre-clinical/translational research, clinical development, and post-approval lifecycle management and product support</li><li> Expert knowledge of relevant FDA, and ICH guidelines, initiatives and related regulations governing product safety in clinical development and post-marketing trials</li><li> Medical communications experience desirable</li><li> Start-up or small company experience strongly preferred </li></ul>Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, the employee may be required at times to attend meetings including travel out of state over weekends and nights. The employee must be able to freely operate and travel by car and train/plane modes of transportation. The employee is required to have a reliable means of transportation. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs. Location <ul><li>This position will be based at Recordati Rare Diseases’ headquarters in Bridgewater, New Jersey </li><li>The position requires domestic travel (approximately 20%); occasional international travel. </li></ul>FLSA Classification <ul><li> This position is considered Exempt. </li></ul>EEO Statement It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodations for qualified individuals with disabilities. Disclaimer This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required. At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

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