Jobs · Business Development · Ohio

Executive Director, Global Patient Safety Sciences Delivery

BioSpace · Dublin, OH · 3 wk ago
Business DevelopmentFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Remove boilerplate, EEO, etc. Keep substantive info. Let's parse the posting. Content: - Intro: "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Patient Safety team." This is about the role. - "The Executive Director, Global Patient Safety Sciences Delivery serves as the key point of contact for all Safety Sciences operations and risk-related responsibilities across all Therapeutic Areas (TAs). This role is responsible for driving consistency across the portfolio for standard activities performed by the Safety Scientists (e.g., data transformation, safety surveillance, SMT preparation, early draft of aggregate reports, signal evaluations, label enhancement justifications). This role is also responsible for the processes and written procedures that underpin the safety governance, and other fundamental processes within Safety Sciences. This role requires the ability to work cross-functionally, partnering with the Safety Sciences TAHs and other leaders. They will serve as a member of the GPS Leadership Team (GPS LT). The Executive Director, Global Patient Safety Sciences Delivery is also responsible for the development and management of their team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide." - "When & Where Work Location: Dublin, Ireland Travel: As needed" - "Discover Your Role Define the strategy to ensure standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and TAs through development of common practices, processes, templates Oversee relevant training programs for GPS Safety Sciences, including a standardized training curriculum, proficiency matrix, and knowledge management repository Enable the Global Capability Center (GCC) to operate more efficiency and scale with the demands of the business Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI Operational Delivery Oversight Ensure compliance and quality management of Safety Sciences Operations activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools Oversee all aspects of signal detection coordination and signal management process across all TAs, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER) Coordinate and support high quality, timely, and compliant delivery of benefit-risk assessment for periodic safety reports (e.g., DSURs, PSURs) and support Safety Sciences Strategy in contributing Medical and Safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) where required Set and oversee the framework for aggregate safety data analysis to ensure effective coordination and delivery Cross-Functional Partnership Serve as strategic point of contact to enable SS operational delivery in partnership with TAHs and GPS Leads Partner with key Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data Management) Talent Development & Organizational Leadership Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines Lead talent strategy and leadership development initiatives that strengthen capabilities across the organization." - "This Role Requires Minimum M.D., PA, PhD or PharmD Degree; Board Certification or equivalent in relevant clinical specialty, MBA is an advantage. 17+ years total experience in PV or relevant clinical experience in the pharmaceutical industry required 6+ years of leading a team and people management experience Preferred experience with oversight of operations within a global patient safety organization Strong attention to detail with the ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution across activities Strong leadership capabilities and presence, interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously #GDPSJobs" - "Does this sound like you? Apply now to take your first step towards living the Regeneron Way!" (application instruction, remove) - EEO boilerplate: remove. - "Where required, we will provide reasonable accommodation..." remove. - "Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually)" This is about benefits and pay but not specific numbers. It mentions benefits generically. According to rules: include Benefits section only if posting actually states them. It does state benefits generically (annual bonuses, equity awards, pension, 401(k) match, health and wellness, fitness centers, insurance, PTO, family support). That's substantive enough? It says "may include, depending on country and role". It's still a statement of benefits. We can include Benefits section with that list. Pay: It mentions salary range but not actual numbers. It says "Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience." No actual numbers given. According to rule: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does not state a specific salary range; it's vague. So we should not include Pay section. Schedule: Not mentioned. So omit. Now sections: About the role (intro), Responsibilities (list of duties), Requirements (education/experience), Qualifications (maybe same as Requirements? but we can combine? The instruction: use headings for section headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what content goes where. We have: - About the role: introductory paragraph about Regeneron and the role. - Responsibilities: list of duties (Define strategy, oversee training, enable GCC, innovative approaches, operational delivery oversight, signal detection coordination, benefit-risk assessment, aggregate safety data analysis, cross-functional partnership, talent development). Could be bullet list. - Requirements: Minimum degree, board certification, MBA advantage, 17+ years experience, 6+ years leading team, preferred experience with oversight of operations within global patient safety organization. - Qualifications: maybe the skills/attributes: strong attention to detail, leadership capabilities, interpersonal, verbal/written communication, organizational and workload planning, ability to manage multiple projects. - Skills: maybe same as qualifications? Could separate: Skills: strong attention to detail, leadership capabilities, interpersonal, verbal/written communication, organizational and workload planning, ability to manage multiple projects. - Benefits: list of benefits. We must not repeat job title as heading. Already not. We must not include Job ID etc. We must output only HTML fragment. Let's craft. Use

for each section heading. Inside sections, use

for prose,

  • for lists. We need to preserve all substantive information, not invent or summarize away detail. Let's extract exact phrases. About the role: "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Patient Safety team." Could also include "The Executive Director, Global Patient Safety Sciences Delivery serves as the key point of contact for all Safety Sciences operations and risk-related responsibilities across all Therapeutic Areas (TAs). This role is responsible for driving consistency across the portfolio for standard activities performed by the Safety Scientists (e.g., data transformation, safety surveillance, SMT preparation, early draft of aggregate reports, signal evaluations, label enhancement justifications). This role is also responsible for the processes and written procedures that underpin the safety governance, and other fundamental processes within Safety Sciences. This role requires the ability to work cross-functionally, partnering with the Safety Sciences TAHs and other leaders. They will serve as a member of the GPS Leadership Team (GPS LT). The Executive Director, Global Patient Safety Sciences Delivery is also responsible for the development and management of their team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide." That's a lot; maybe split between About the role and Responsibilities. But we can put the introductory part in About the role, and the detailed duties in Responsibilities. Thus About the role: first two sentences. Responsibilities: list of duties as bullet points. Let's extract duties from "Discover Your Role" section and earlier. Duties: - Define the strategy to ensure standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and TAs through development of common practices, processes, templates - Oversee relevant training programs for GPS Safety Sciences, including a standardized training curriculum, proficiency matrix, and knowledge management repository - Enable the Global Capability Center (GCC) to operate more efficiency and scale with the demands of the business - Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI - Operational Delivery Oversight: Ensure compliance and quality management of Safety Sciences Operations activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools - Oversee all aspects of signal detection coordination and signal management process across all TAs, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER) - Coordinate and support high quality, timely, and compliant delivery of benefit-risk assessment for periodic safety reports (e.g., DSURs, PSURs) and support Safety Sciences Strategy in contributing Medical and Safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) where required - Set and oversee the framework for aggregate safety data analysis to ensure effective coordination and delivery - Cross-Functional Partnership: Serve as strategic point of contact to enable SS operational delivery in partnership with TAHs and GPS Leads - Partner with key Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data Management) - Talent Development & Organizational Leadership: Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines - Lead talent strategy and leadership development initiatives that strengthen capabilities across the organization. We could combine some. Now Requirements: "Minimum M.D., PA, PhD or PharmD Degree; Board Certification or equivalent in relevant clinical specialty, MBA is an advantage. 17+ years total experience in PV or relevant clinical experience in the pharmaceutical industry required 6+ years of leading a team and people management experience Preferred experience with oversight of operations within a global patient safety organization" We need to keep exact phrasing. Qualifications/Skills: "Strong attention to detail with the ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution across activities Strong leadership capabilities and presence, interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously" We could split: Qualifications: maybe the degree/experience? But we already used Requirements for that

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