NewSenior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines CSL SeqirusSenior Manager, Regional Regulatory Lead – North America, Seqirus VaccinesHolly Springs, NC$154,000–$182,000The role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Director, Quality Control CellectisDirector, Quality ControlRaleigh, NCAs a member of the site Quality Leadership Team, the Director partners cross-functionally with Manufacturing m QA, MSAT, AS&T, and Regulatory to support clinical and commercial manufacturing while advancing quality culture and operational excellence. The Director, Quality Control provides strategic and operational leadership for all Quality Control (QC) activities supporting drug substance (DS) and dug product (DP) manufacturing at the site.
NewRegulatory Affairs Director IQVIARegulatory Affairs DirectorDurham, IllinoisThe actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). • Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results.
Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyRaleigh, NCDevelopment and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.
Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals IncDirector, Regulatory Affairs - Clinical StrategyRaleigh, NCBrief Team/Department Description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical Strategy will conduct in-depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. Principle Responsibilities: • Development and implementation of clinical regulatory strategies and tactics, including but not limited to, Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, while considering FDA and other health authority clinical and regulatory requirements.
Senior Director, Advertising and Promotional Compliance Lead - Global Regulatory Affairs Merz North America IncSenior Director, Advertising and Promotional Compliance Lead - Global Regulatory AffairsRaleigh, NCThe individual will oversee or represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and must possess a thorough knowledge of regulations for medical affairs activities, advertisement and promotional compliance governing drugs, device, cosmetic, and combination products and the ability to translate regulatory requirements into decision-ready guidance for senior stakeholders. Lead the team within Global Regulatory Affairs that provides strategic regulatory expertise and guidance to global internal leaders and stakeholders regarding the marketing of products including review of advertising, promotional and other related materials to ensure compliance with applicable regulations and guidance documents.
Director (Senior Director), Regulatory Affairs Shattuck Labs IncDirector (Senior Director), Regulatory AffairsDurham, NCIncluded among the necessary activities are: oversight of regulatory CRO activities, planning and leading: meetings with regulatory authorities, compilation and submission of high-quality INDs, CTAs, BLAs/MAAs, meeting packages, responses to requests for information, amendments, and required elements such as safety reports, annual reports. Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities including INDs, CTAs, BLAs, MAAs, amendments, responses to information requests and questions, safety reports, and annual updates/DSURs for assigned projects.
Sr. Director, Strategic Regulatory Affairs and UDI Teleflex IncSr. Director, Strategic Regulatory Affairs and UDIMorrisville, NC$203,000–$253,000 / yearThe position leads a global organization through a team of managers and functional leaders and serves as a key partner to Regulatory Affairs, Quality, Supply Chain, Manufacturing, Information Technology, Commercial, and Executive Leadership teams to ensure regulatory compliance, support global market access, and enable business growth. The Senior Director, Strategic Regulatory Affairs & UDI provides leadership and oversight for global regulatory operations, regulatory systems, unique device identification (UDI), regulatory data governance, import/export regulatory compliance support, and regional Regulatory Affairs and Quality functions.
Senior/Director - Regulatory Affairs implaionSenior/Director - Regulatory AffairsDurham, NCThe company is seeking a Director or Senior Director of Regulatory Affairs — with the final title set according to the selected candidate's background — to help shape and steer the execution of worldwide regulatory strategy across assigned programs, keeping all work consistent with applicable national and regional requirements as well as internal policy. Direct the assembly of regulatory filings, overseeing the planning, coordination, drafting, and review of every submission sent to health authorities worldwide — including INDs, CTAs, BLAs, MAAs, amendments, replies to questions and information requests, safety reports, and annual updates/DSURs for assigned projects.
NewRegulatory Affairs Director IQVIA Holdings IncRegulatory Affairs DirectorDurham, NC$128,800–$358,800 / yearThe actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results.
Associate Director, Regulatory Affairs (CMC) Kriya Therapeutics IncAssociate Director, Regulatory Affairs (CMC)Morrisville, NCThe Associate Director Regulatory Affairs CMC possesses strong leadership skills, broad knowledge of multiple aspects of regulatory affairs beyond CMC, across all phases of drug development, and a deep understanding of global CMC regulations, including GMP and region-specific guidelines, especially as they relate to gene therapies. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
Director, Regulatory Affairs CMC ProPharma Group Holdings LLCDirector, Regulatory Affairs CMCRaleigh, NCThe Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is a senior-level contractor role responsible for defining and executing global CMC regulatory strategies across Dyne's development programs, from early-stage development through commercialization and post-approval lifecycle management. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Associate Director, Regulatory Affairs (CMC) Kriya TherapeuticsAssociate Director, Regulatory Affairs (CMC)Research Triangle Park, NCThe Associate Director, Regulatory Affairs (CMC) possesses strong leadership skills, broad knowledge of multiple aspects of regulatory affairs (beyond CMC) across all phases of drug development, and a deep understanding of global CMC regulations, including GMP and region-specific guidelines, especially as they relate to gene therapies. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
Associate Director, Regulatory Affairs Baxter International IncAssociate Director, Regulatory AffairsRaleigh, NC$176,000–$242,000 / yearRecruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. May participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc.).May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics United Therapeutics CorpRegulatory Affairs Manager / Senior Regulatory Affairs Manager - BiologicsNCProvide regulatory support for assigned products/projects, coordinating cross-functional activities with various UTC product development groups (e.g., nonclinical, clinical, quality, marketing, safety, medical) to support execution of regulatory activities and adherence to established timelines. The Regulatory Affairs Manager, Biologics/Senior Regulatory Affairs Manager, Biologics will lead regulatory activities for assigned existing and new programs, supporting product development from early development through post-approval.
Senior Medical Director , US Immunology Medical Affairs Swedish Orphan Biovitrum ABSenior Medical Director , US Immunology Medical AffairsRaleigh, NC$260,000–$295,000 / yearDevelop and foster strong collaborative relationships with internal partners, including Regulatory Affairs, Clinical Operations, Market Access, Medical Information, Pharmacovigilance, Sales and Marketing, Global product leadership, Global medical affairs, and clinical development, providing strategic medical insight and product/disease-state expertise to meet business objectives. Additionally, the Senior Medical Director will be a key contributor to the global life cycle management-led activities, including programs for future indications, cytokine testing, Investigator-Initiated Study strategy, and overall input into the creation and execution of product evidence generation plans.
Associate Corporate Compliance Director - Commercial & Medical Affairs United Therapeutics CorpAssociate Corporate Compliance Director - Commercial & Medical AffairsNC$145,500–$205,000 / yearBachelor's Degree in business, finance, life sciences, healthcare, information systems or related field with 12+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech) or, Master's Degree with 10+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech). The Associate Corporate Compliance Director reports to the Senior Corporate Compliance Director and serves as a key compliance business partner to Commercial and Medical Affairs, including Sales, Marketing, Commercial Training and Development, Patient Advocacy, and Medical Affairs.
Executive Director, Clinical Development & Medical Affairs Humacyte IncExecutive Director, Clinical Development & Medical AffairsDurham, NCCOMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease.
Rheumatology (Senior) Medical Director - Medical Affairs Swedish Orphan Biovitrum ABRheumatology (Senior) Medical Director - Medical AffairsMorrisville, NC$224,000–$290,000 / yearDevelop and foster strong collaborative relationships with internal partners, including Regulatory Affairs, Clinical Operations, Market Access, Medical Information, Pharmacovigilance, Sales, and Marketing, and provide medical insight and product- and disease-state expertise to meet business objectives. Develop a US evidence generation strategy to address stakeholder (HCPs, payers, and patients) needs (including product differentiation, health outcomes), collaborating with HEOR and global partners.
Senior Medical Director - Medical Monitoring (Clinical & Medical Affairs) United Therapeutics CorpSenior Medical Director - Medical Monitoring (Clinical & Medical Affairs)NCThe cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals - USVice President, Global Head of Regulatory AffairsRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.
Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals IncVice President, Global Head of Regulatory AffairsRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.
Director of Regulatory - Biological & Traditional Fertilizers The Mosaic CoDirector of Regulatory - Biological & Traditional FertilizersDurham, NCLead global regulatory strategy and product registration activities across North America, Europe, Latin America, and Asia-Pacific; oversee preparation, submission, and lifecycle management of regulatory dossiers (federal/state registrations, REACH, fertilizer/biostimulant regulations); ensure compliance with labeling, safety, environmental, and composition requirements; manage audits, inspections, and regulatory authority interactions for Biosciences and support these functions for traditional fertilizer. The Director of Regulatory Affairs - Biological & Traditional Fertilizers, reporting to the Vice President of Product Innovation, leads the global regulatory strategy, registration, and compliance for a diverse portfolio of conventional fertilizer and biological products, ensuring full adherence to regulatory requirements while enabling innovation, speed to market, and sustained commercial growth.
Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) Parexel International CorpSenior Regulatory Affairs Consultant (Program / Client Partnership Manager)NCYou will play a key leadership role in managing midsize to large Regulatory Affairs outsourcing programs, partnering closely with clients and cross-functional teams to drive operational excellence, ensure delivery against regulatory objectives, and support the successful progression of development and commercial programs. Due to continued growth and the ongoing success of our Regulatory Affairs Consulting team, Parexel is seeking an experienced Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) to join our team.
Manager Regulatory Affairs Bioventus IncManager Regulatory AffairsDurham, NCWorks with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products. Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsDurham, NC$113,850–$189,750 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
Senior Manager, Regulatory Affairs (Ad Promo) IRESenior Manager, Regulatory Affairs (Ad Promo)Raleigh, North CarolinaContribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices. Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
Manager/Sr. Manager, Regulatory Affairs (Labeling) Grifols SAManager/Sr. Manager, Regulatory Affairs (Labeling)Clayton, NCSummary: Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements.
Ld Dir, Corporate Affairs Technology CVS Health CorpLd Dir, Corporate Affairs TechnologyNC$144,200–$288,400 / yearThis role partners with Corporate Affairs leadership to enable regulatory compliance, risk management, and enterprise protection through modern, scalable, and AI-driven technology solutions. This position is a leader-of-leaders role, with direct oversight of Senior Managers and their teams, and is accountable for delivering business-aligned outcomes across the Corporate Affairs application portfolio.
Manager, Government Affairs North Carolina's Electric CooperativesManager, Government AffairsRaleigh, North CarolinaCompany Profile: North Carolina’s Electric Cooperatives (http://ncemcs.com/about/ncemc.htm) is the brand for the family of organizations formed to support the state’s 26 local electric cooperatives, including: North Carolina Electric Membership Corporation, the power supplier to many of the electric cooperatives; North Carolina Association of Electric Cooperatives, the cooperatives’ trade association; and Tarheel Electric Membership Association, Inc. (TEMA), a central purchasing and materials-supply cooperative. Summary Description: At North Carolina’s Electric Cooperatives you will be part of an exciting mission to build a Brighter Future for our state and rural communities, making a real difference in the lives of 2.8 million consumer members.
Director, Data Sciences, Safety and Regulatory, FSP Sales IQVIADirector, Data Sciences, Safety and Regulatory, FSP SalesDurham, North CarolinaMaintaining general knowledge of all IQVIA R&DS services for appropriate cross-sell opportunities and working across company's service lines and with sales teams to cross-promote and respond to RFPs as well as develop internal relationships needed to create solutions designed using multiple services. Director, Data Sciences, Safety and Regulatory, FSP Sales will contribute to a major segment of the Sales organization – FSP services for the Data Management, Biostatistics, Programming, Medical Writing, Lifecycle Safety, and Regulatory Affairs functions - and will be responsible for achieving FSP Sales targets from assigned portfolio of accounts.
Director of Academic Advising, Duke University School of Law Duke UniversityDirector of Academic Advising, Duke University School of LawDurham, NC$61,535–$95,880 / yearServe as administrative lead for the academic support program-administer and evaluate universal support programs; identify students needing individual support; coordinate with faculty offering academic support; and provide individual support for at-risk students. Leaves of Absence, Transfers, and Visitors: Manage requests to visit away; provide advising for transfers and visitors; coordinate leave-related academic guidance with Student Affairs; ensure accurate information is maintained by the Registrar.
Director of Business Development, Life Sciences (HEOR) Staffing MeeDerbyDirector of Business Development, Life Sciences (HEOR) StaffingCary, NCRemoteThey are known for delivering high-impact real-world evidence, economic modeling, and value strategy solutions that help biotech, pharma, and medical device companies secure market access and reimbursement. Were hiring for a Business Development Director to drive new business and expand client relationships within HEOR and market access services.
Director of Government Relations Progress ResidentialDirector of Government RelationsRaleigh, NCReporting to the Vice President of Government Affairs, the Director will be responsible for executing government relations strategies, influencing key decision-makers, building durable relationships, and effectively communicating Progress' and/or the industry's positions before state and local governments, with limited federal engagement as needed. Job Summary: The Director of Government Relations will represent Progress Residential ("Progress") by advocating before state and local government officials on policies relevant to Progress Residential, its affiliates, Owners, and Property Managers in the Single-Family Rental ("SFR") industry.
NewAssistant Director of Planning & Development Raleigh City CouncilAssistant Director of Planning & DevelopmentRaleigh, NC$134,100–$214,600 / yearSupervises, manages, and evaluates assigned staff; makes decisions regarding hiring, discipline, and termination; prioritizes and assigns work; develops and oversees employee schedules and approves leave; provides and/or coordinates training and development; addresses employee concerns and problems; administers appropriate corrective actions; completes performance evaluations; recommends starting salaries and salary adjustments; and serves as liaison between employees and management. Raleigh Planning and Development oversees the development process throughout more than 180 square miles of corporate limits and planning jurisdiction; from the legislative beginning of the process including maintaining the City's Comprehensive Plan and Unified Development Ordinance; through to completion of individual buildings, including site planning reviews, building permit issuance, and inspections.
Regulatory Planning & CON Specialist UNC HealthRegulatory Planning & CON SpecialistMorrisville, NC$41.45–$59.58 / hourWorking closely with the Director, Regulatory Affairs & Facility Strategy team members, internal stakeholders, and external advisors, this position plays a critical role in shaping narratives, ensuring consistency and accuracy across regulatory submissions, and supporting leadership communications related to regulatory strategy and facilities planning. This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Health Care System, in a department that provides shared services to operations across UNC Health Care; except that, if you are currently a UNCHCS State employee already working in a designated shared services department, you may remain a UNCHCS State employee if selected for this job.
Program Manager I Faculty Affairs Advocate Health and Hospitals CorporationProgram Manager I Faculty AffairsWake Forest, North CarolinaImplements and coordinates all faculty development programs and initiatives across the Faculty Development and Success portfolio, translating approved plans into detailed timelines, task lists, and execution workflows in collaboration with the Office of Faculty Affairs (OFA), academic departments, and institutional partners. Assists with basic budget tracking and logistical coordination for events and programs (e.g., materials, catering, speaker arrangements), in accordance with established processes and approvals, and provides team leadership and OFA administration personnel with approved receipts and invoices.
NewViiV Healthcare (GSK) Senior Manager, External Affairs Giving GSK plcViiV Healthcare (GSK) Senior Manager, External Affairs GivingDurham, NC$129,000–$215,000 / yearThe Senior Manager, External Affairs Giving is responsible for advancing ViiV Healthcare's U.S. community investment strategy by identifying, evaluating, recommending, and managing strategic grantmaking and partnerships that improve HIV prevention, treatment, retention in care, health equity, and community capacity. This role serves as a key leader within U.S. External Affairs, partnering with internal stakeholders and community organizations to ensure investments align with ViiV Healthcare's strategic priorities while addressing the evolving needs of communities disproportionately impacted by HIV.
Leader Medical Affairs Canon USA & AffiliatesLeader Medical AffairsRaleigh, NCRemote10 years’ experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting or 3 years of experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting plus 7 years of experience in healthcare industry as imaging scientist or research manager. Analyze and communicate technical and clinical product specification requirements from luminaries, market research teams, and via Medical Advisory Boards (MABs) to global business team.
Regulatory Compliance Lead GSK plcRegulatory Compliance LeadNCPosition Summary: This role leads a team of professionals acting as advisor, facilitator and team member regarding regulatory compliance and pertinent quality systems for all aspects of the manufacturing, testing, storage and distribution of pharmaceutical products. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Senior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines CSL PlasmaSenior Manager, Regional Regulatory Lead – North America, Seqirus VaccinesHolly Springs, North CarolinaThe role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Local Study Associate Director- FSP Parexel International CorpLocal Study Associate Director- FSPNCRemoteThe Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.
Local Study Associate Director - FSP Parexel International CorpLocal Study Associate Director - FSPNCThe Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.
Sr. Director, Specialty Respiratory Strategic Engagement & Portfolio and Pipeline Strategy GSK plcSr. Director, Specialty Respiratory Strategic Engagement & Portfolio and Pipeline StrategyDurham, NC$195,750–$326,250 / yearDirector, Specialty Respiratory Strategic Engagement & Portfolio/Pipeline Strategy leads the integrated U.S. commercial strategy for the Specialty Respiratory portfolio and pipeline within Marketing, serving as the primary commercial voice for Specialty Respiratory across the asset continuum from early development through lifecycle management. Holds direct accountability for the strategic engagement and portfolio strategy budget across Specialty Respiratory, making prioritization decisions across congress, P2P, market research, and pipeline strategy programs within VP-delegated authority.
Senior Associate Director, Financial Communications (Private Capital) APCO Worldwide LLCSenior Associate Director, Financial Communications (Private Capital)NC$171,000–$202,000 / yearDevelops and executes communications strategies across the private markets lifecycle: firm positioning and brand building, fund launches and final closes, platform acquisitions, add-on transactions, recapitalizations, exits and IPOs of portfolio companies, LP communications support, and ESG/responsible investing narratives. This is a senior client-facing role for a sophisticated operator who serves as a primary counselor to private investment firms , IR teams, and portfolio company leadership across the full lifecycle of private markets activity, from fundraising and platform investments through bolt-ons, value creation, and exits.
Immunology Business Director (HS) - Carolinas Incyte CorpImmunology Business Director (HS) - CarolinasNCThrough the discovery development and commercialization of proprietary therapeutics Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology Oncology and Inflammation and Autoimmunity Headquartered in Wilmington Delaware Incyte has operations in North America Europe and Asia. The Immunology Business Director IBD will be accountable for translating brand strategy into disciplined field execution coaching and developing high-performing Therapeutic Specialists and delivering demand generation to support launch excellence and sustained growth.
Director, Regional Marketing Lead (East Region) Ideaya Biosciences IncDirector, Regional Marketing Lead (East Region)NC$196,000–$242,000 / yearReporting into Commercial Strategy & Marketing, this field-based role will serve as a key commercial engagement partner responsible for developing relationships with priority thought leaders & academic centers, gathering actionable marketplace insights, supporting peer-to-peer education, and helping shape launch strategy in partnership with Marketing, Medical Affairs, Sales, Value & Access, and other cross-functional teams. The RML will play a critical role in helping IDEAYA transition to a commercial-stage organization by strengthening scientific engagement, supporting launch readiness activities, and building meaningful relationships with key stakeholders across academic and community oncology settings.
Director, IME and HCO Funding GSK plcDirector, IME and HCO FundingDurham, NC3+ years of relevant pharmaceutical/biotechnology industry experience within medical affairs or related functions with demonstrated ability to lead and manage external funding, medical grants, medical affairs operations, compliance or related functions with operational leadership experience. Partner with USMA relationship leads to act as primary point of contact for funding with non-promotional education partners (such as medical education providers, AMCs, societies, advocacy groups, etc), communicating processes, criteria, and compliance requirements.
Lead, Regional Medical Science Director Summit TherapeuticsLead, Regional Medical Science DirectorRaleigh, North CarolinaHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. Support clinical development and research initiatives across development at the request of R&D to include, but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and involving experts to generate scientific data including investigator-sponsored trials.
Director, Product Communications Definium Therapeutics IncDirector, Product CommunicationsDurham, NC$192,904–$226,600 / yearThis individual will report into the VP of Corporate Communications, and will work in close partnership with Commercial, Medical Affairs, Investor Relations, Human Resources, Patient Advocacy, Government Affairs, and other cross-functional leaders to develop clear, compliant, and high-impact messaging and programming across earned, owned, social/digital, and shared channels. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder.