Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical) Atsena Therapeutics IncAssociate Director or Director, Regulatory Strategy (Clinical & Nonclinical)Durham, NCLead preparation and submission of global regulatory filings including: INTERACT and PreINDs, INDs and IND amendments, CTAs and IMPDs, orphan drug designation applications, Fast Track, RMAT and other expedited program submissions Ensure high-quality regulatory documentation aligned with agency expectations. Position Summary: The Associate Director / Director, Regulatory Strategy (Clinical & Nonclinical) will lead global regulatory strategy and execution for the company's gene therapy programs from early research through clinical development and commercialization.
Associate Director or Director, CMC Regulatory Affairs Atsena Therapeutics IncAssociate Director or Director, CMC Regulatory AffairsDurham, NCLead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates Ensure submissions meet regulatory expectations for gene therapy products. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.
Associate Director / Director, Facilities & Maintenance Beam Therapeutics IncAssociate Director / Director, Facilities & MaintenanceDurham, NC$185,000–$260,000 / yearIn addition to a strong facilities, maintenance, and reliability background, the ideal candidate should also possess the ability to successfully interface with multidisciplinary teams as well as engage and collaborate with external partners, manufacturing operations, quality and validation, and finance. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA.
Associate Director/Director Business Development Genomics plcAssociate Director/Director Business DevelopmentResearch Triangle Park, NCGenomics aims to help people live longer, healthier lives in two ways: super-charging drug discovery and development for novel treatments with our AI-enabled advanced genetic analytics platform, and by helping people understand their personal risk of common chronic diseases through polygenic risk scores - giving doctors and health systems the chance to get the right people into the right prevention, screening and treatment programmes at the right time. Strategic New Business: You'll own and drive the most significant new commercial opportunities across pharma and biotech - building multi-stakeholder relationships at senior and executive level and leading complex, high-value sales cycles from first conversation to contract close.
Associate Director/Director Business Development Genomics LtdAssociate Director/Director Business DevelopmentNCGenomics aims to help people live longer, healthier lives in two ways: super-charging drug discovery and development for novel treatments with our AI-enabled advanced genetic analytics platform, and by helping people understand their personal risk of common chronic diseases through polygenic risk scores - giving doctors and health systems the chance to get the right people into the right prevention, screening and treatment programmes at the right time. Strategic New Business: Youll own and drive the most significant new commercial opportunities across pharma and biotech - building multi-stakeholder relationships at senior and executive level and leading complex, high-value sales cycles from first conversation to contract close.
Director/ Associate Director, Strategic Programs Syneos HealthDirector/ Associate Director, Strategic ProgramsMorrisville, North CarolinaWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • Support knowledge transfer (KT) efforts as a key transformational element, ensuring process clarity, consistency, and continuity across teams in an effort to mitigate risk for business continuity.
Director/ Associate Director, Strategic Programs Syneos Health IncDirector/ Associate Director, Strategic ProgramsMorrisville, NCTogether we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. Selecting us as an employer secures a career in which you're guaranteed to: Collaborate with passionate problem solvers Partner with the most diverse team of experts in the industry.
Associate Director/Director, Facilities & Maintenance Beam TherapeuticsAssociate Director/Director, Facilities & MaintenanceDurham, NC$185,000–$260,000 / yearIn addition to a strong facilities, maintenance, and reliability background, the ideal candidate should also possess the ability to successfully interface with multidisciplinary teams as well as engage and collaborate with external partners, manufacturing operations, quality and validation, and finance. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA.
Associate Director / Director, Project Management - Renal diseases - US/Canada - Remote Worldwide Clinical Trials Holdings IncAssociate Director / Director, Project Management - Renal diseases - US/Canada - RemoteNCRemote$128,500–$254,500 / yearUniversity/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities. Work effectively across multiple divisions to direct the delivery of projects/programs within cost, time and quality requirements, and ensure successful design, implementation, tracking and revision of project plans for assigned projects.
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.
Associate Director, Fulfillment Service Of Process Wolters KluwerAssociate Director, Fulfillment Service Of ProcessCary, NC$94,600–$169,100 / yearYou're a Great Fit if You Have These Skills: Operational Leadership- Demonstrated ability to lead complex, high-volume operations through multiple managers and teams while maintaining strong performance across service, quality, productivity, compliance, and customer outcomes. What You'll be Doing: As the Associate Director, Service of Process, you will provide senior operational leadership for the receipt, processing, documentation, and timely forwarding of service of process, legal notices, and official government correspondence on behalf of clients served through our national registered agent network.
Associate Director - Field Reimbursement Manager, Oncology - Mid-Atlantic Bayer AGAssociate Director - Field Reimbursement Manager, Oncology - Mid-AtlanticDURHAM, NCLocation:United States: District of Columbia: Residence Based || United States: District of Columbia: Washington || United States: North Carolina: Asheville || United States: North Carolina: Cary || United States: North Carolina: Chapel Hill || United States: North Carolina: Charlotte || United States: North Carolina: Clayton || United States: North Carolina: DURHAM || United States: North Carolina: DURHAM || United States: North Carolina: Durham || United States: North Carolina: Fayetteville || United States: North Carolina: Gastonia || United States: North Carolina: Greensboro || United States: North Carolina: Greenville || United States: North Carolina: Hickory || United States: North Carolina: Kannapolis || United States: North Carolina: Matthews || United States: North Carolina: Morrisville || United States: North Carolina: Mount Olive || United States: North Carolina: Mt Olive || United States: North Carolina: Pikeville || United States: North Carolina: Raleigh || United States: North Carolina: Research Triangle Park || United States: North Carolina: Residence Based || United States: North Carolina: Rocky Mount || United States: North Carolina: Statesville || United States: North Carolina: Wilmington || United States: North Carolina: Wilson || United States: North Carolina: Winston-Salem || United States: South Carolina: CHARLESTON NORTH || United States: South Carolina: COLUMBIA WEST || United States: South Carolina: Charleston || United States: South Carolina: Columbia || United States: South Carolina: FLORENCE || United States: South Carolina: Greenville || United States: South Carolina: Greenwood || United States: South Carolina: Hartsville || United States: South Carolina: Myrtle Beach || United States: South Carolina: Residence Based || United States: South Carolina: Spartanburg || United States: South Carolina: Summerville || United States: Virginia: Arlington || United States: Virginia: CHARLOTTESVILLE || United States: Virginia: Chantilly || United States: Virginia: Charlottesville || United States: Virginia: Chesterfield || United States: Virginia: Fairfax || United States: Virginia: Fredericksburg || United States: Virginia: Hampton || United States: Virginia: Lynchburg || United States: Virginia: Norfolk || United States: Virginia: Residence Based || United States: Virginia: Richmond || United States: Virginia: Roanoke || United States: Virginia: Virginia Beach || United States: Virginia: WOODBRIDGE Division:Pharmaceuticals Reference Code:879452 Contact Us Email:hrop_usa@bayer.com. Bachelor's Degree or minimum of 5 years' healthcare related reimbursement experience; 2 + years Field Reimbursement experience; In depth understanding of Payer/PBM therapy approval requirements (Prior Authorization, Medical Necessity, Denial Appeals, Formulary coverage and payment for oncology therapies across all sites of care (hospital, clinic, integrated delivery network) and ability to apply this knowledge to address individual customer concerns; Broad knowledge of Medicare, managed care, third party payers and Medicaid; Demonstrated excellence in meeting and exceeding customer expectations especially in demanding situations; Ability to effectively address customer concerns in a timely fashion and by working collaboratively with external and internal stakeholders; An elevated level of sophistication/people skills needed to interact with practice clinical decision makers, office support staff, clinical pharmacists, and office managers; Must demonstrate a comprehensive knowledge of customer relations, therapy formulary coverage, utilization management, and able to interpret complex information; Must possess the leadership ability to effectively organize, communicate and collaborate with HCPs, Key Practice Staff and Bayer external and internal team members; Exceptional knowledge of Healthcare Management; Pharmaceutical Manufacturer federal, state, and local compliance requirements; Area Reimbursement Managers will cover multiple regions, thus significant overnight travel, up to 50%; Must have a valid driver''s license with a safe driving record/ MVR.
Associate Director, Venture Banking Live Oak BankAssociate Director, Venture BankingDurham, NC$128,500–$179,900 / yearThe Associate Director, Venture Banking will enable the success of the Venture Banking team by sourcing new client opportunities, winning those opportunities, onboarding new relationships, and taking ownership of the relationships post-loan closing/onboarding under the direction of the Managing Director. Those applicants requiring reasonable accommodation to the application and/or interview process should notify human resources at HumanResources@liveoak.bank.
Open Rank Faculty/Associate Director for Basic Cancer Research University of North Carolina at Chapel HillOpen Rank Faculty/Associate Director for Basic Cancer ResearchChapel Hill, NCAdministrative duties include: upon request, perform reviews of grant applications and investigator-initiated clinical trials originating from the Center to ensure basic science opportunities are embedded into each, as appropriate; attend and actively participate in LCCC research program meetings to foster programmatic content that is inclusive of basic science concepts; at the direction of the Cancer Center Director, represent the program during NCI site visits and annual External Advisory Board meetings; work collaboratively with fellow Associate Directors to co-create a scientific community at Lineberger reflective of all components of an NCI-designated comprehensive cancer center. Department Lineberger Compr Cancer Center - 426801 Posting Open Date 11/25/2024 Application Deadline Open Until Filled Yes Position Type Permanent Faculty Working Title Open Rank Faculty/Associate Director for Basic Cancer Research Appointment Type Admin Appointment with Faculty Rank Vacancy ID FAC0005376 Full-time/Part-time Full-Time Permanent Hours per week 40 FTE 1 Position Location North Carolina, US Hiring Range Dependent on Qualifications/Experience Proposed Start Date 03/01/2025.
Associate Director, Technical Operations Drug Substance Merck & Co IncAssociate Director, Technical Operations Drug SubstanceDurham, NC$142,400–$224,100 / yearRequired Skills: API Manufacturing, Aseptic Processing, Biologics, Change Control Systems, Chemical Process Development, Cross-Cultural Awareness, Cross-Functional Teamwork, Equipment Qualification, Manufacturing Process Validation, People Leadership, Process Optimization, Regulatory Inspections, Regulatory Requirements, Results-Oriented, Strategic Thinking, Technical Guidance, Technology Transfer. Effectively manage a team of engineers and scientists supporting drug substance technical transfer by developing a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.
Associate Director, Success Teams Sunflower Services PBCAssociate Director, Success TeamsDurham, NCRemote$80,000–$95,000 / yearThis includes: Build strong relationships with project staff, earning trust through clear and consistent communication, strong project management and adherence to accountabilities, and consistently approach client service with a problem-solving mindset. Independently project manage a portfolio of complex fiscally sponsored projects by leading workstreams, fostering team communications, and overseeing the execution of work completed by junior staff members.
Senior Manager/Associate Director, Environmental Affairs Cypress Creek Renewables LLCSenior Manager/Associate Director, Environmental AffairsDurham, NCProvide subject matter expertise support during financing, which would include responding to Independent Engineers and external legal counsel comments, advising on contractual terms and conditions for environmental risk, and supporting internal legal, tax, and finance teams to compile environmental documentation. Directly oversee scoping and managing complex, environmental regulatory compliance processes, such as targeted environmental resource studies (e.g., wetland delineations, Phase I ESAs, cultural resource surveys), environmental permitting, and mitigation negotiation, within the Company and with outside consultants.
Senior Manager/Associate Director, Drug Substance MSAT FUJIFILM Biotechnologies USA IncSenior Manager/Associate Director, Drug Substance MSATHolly Springs, NCOwns product and process stewardship by leading end to end technical strategy execution for assigned products in the suite from new product introduction through commercialization, covering upstream (seed/production bioreactors) and downstream (purification trains). The Associate Director serves as the suite's technical owner in client forums, translating product requirement needs into clear plans, stage gates, and flawless execution to enable compliant, on time Drug Substance delivery.
Supply Chain and Engineering- Software Defined Vehicle (SDV) Go-To-Market, Senior Manager / Associate Director Accenture PlcSupply Chain and Engineering- Software Defined Vehicle (SDV) Go-To-Market, Senior Manager / Associate DirectorRaleigh, NCAs a Software Defined Vehicle (SDV) Go-to-Market Senior Manager / Associate Director, you will play a critical role in shaping client solutions, supporting complex sales pursuits, and leading delivery execution across SDV engagements. The practice brings together deep engineering, embedded software, platform, cloud, and industry expertise to support clients across the full SDV lifecycle-from strategy and architecture through delivery, industrialization, and operationalization.
Associate Director, Analytical Sciences implaionAssociate Director, Analytical SciencesDurham, North CarolinaD. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years of experience in the Pharmaceutical/Biotech analytical CMC industry, or B.S./M.S. in in Chemical/Biochemical Engineering or related Biological Sciences with 12 years of experience in the Pharmaceutical/Biotech industry analytical CMC industry. Working collaboratively with Analytical Project Leads and other functional leaders, the Associate Director will help integrate analytical activities across programs, strengthen technical capabilities, and prepare development programs for late-stage clinical development and eventual commercialization.