Marketing Director
Director of strategy job in Raleigh, NC
Marius Pharmaceuticals is a patient‑centric healthcare company developing therapies for hypogonadism (Testosterone Deficiency). We focus on optimizing metabolic function, healthspan, and longevity, while addressing the burdens associated with Testosterone Deficiency through rational, practical, and innovative solutions.
We are best known for KYZATREX , an FDA-approved oral testosterone therapy, designed to redefine how Testosterone Deficiency is treated. As a company, we thrive at the edge of innovation, moving quickly and decisively to change the standard of care and put patients first.
For more, visit mariuspharma.com.
Position Overview
We are seeking a fast-moving, creative, and impact-driven Marketing Director to join our leadership team. This is a role for a builder-not a maintainer. The ideal candidate thrives in ambiguity, embraces a “run fast, break stuff, fix it better” mindset, and knows how to cut through complexity to deliver results.
As an individual contributor and leader, you will move at startup speed to drive awareness, growth, and adoption of KYZATREX and Testosterone Deficiency as a critical health issue. You will set bold strategies, experiment rapidly, and execute with precision-balancing the discipline of a regulated industry with the urgency of a category-defining product.
Primary Responsibilities
• Run fast & drive impact: Execute bold marketing strategies with urgency-prioritizing outcomes over bureaucracy.
• Build the category: Create massive awareness for Testosterone Deficiency and Testosterone as a metabolic hormone.
• Position KYZATREX as #1: Make oral testosterone the default choice by highlighting its clear advantages over injections and creams.
• Story tell at scale: Generate powerful content-video, audio, text, mixed media-that resonates with patients, physicians, and partners.
• Leverage voices of authority: Activate senior management, patient advocates, and KOLs to amplify credibility and reach.
• Experiment relentlessly: Test and learn across earned, owned, and paid channels- SEO, SEM, social, email, PR-with rapid iteration.
• Demand data: Track KPIs obsessively, optimize campaigns on the fly, and report actionable insights to leadership and the board.
• Collaborate, but push: Work with sales, regulatory, operations, and finance-but drive forward with urgency even when rules slow others down.
• Expand reach: Identify new market opportunities (domestic & international) and move fast to capture them.
What We're Looking For
• A proven growth marketer who has built audiences and driven measurable results in high-stakes or regulated industries.
• 7+ years of progressive marketing leadership, ideally including pharma, biotech, or consumer health.
• Fluent in digital and social media platforms, with the ability to move from strategy to execution in the same day.
• A creative disruptor who thinks beyond templates and finds new ways to win attention and loyalty.
• Strong business acumen with the confidence to challenge assumptions and make tough calls.
• Relentless bias for action-you move fast, adjust faster, and get things done.
Why Join Us
At Marius, you won't just market a product-you'll redefine a category. This is a role for someone who wants to leave a mark, move quickly, and help build a company from the ground up.
Equal Employment Opportunity Statement
Marius Pharmaceuticals is an equal-opportunity employer. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, gender, sexual orientation, gender identity, pregnancy, childbirth or related medical conditions, age, veteran status/military status, disability, genetic information, or any other protected characteristic. This policy extends to all terms and conditions of employment.
Director - Patient Strategy, Anti-Infectives
Director of strategy job in Durham, NC
Site Name: USA - Pennsylvania - Philadelphia, Durham Blackwell Street Job Title: Director Patient Strategy, Anti-Infectives Are you looking for a challenging commercial role that allows you to influence a broad range of global leaders and helping to shape regional marketing
solutions? If so, this Product Brand Management Director role could be an exciting opportunity to consider.
Business Introduction
GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing
strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is
centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems.
Our diverse portfolio consists of vaccines, specialty medicines, and general medicines.
Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking
treatments that address critical health challenges.
Position Summary
As the Patient Strategy lead for Anti-infectives, you will develop and lead Patient strategy and Patient-centric commercial models, reporting to the Sr.
Director, Portfolio Commercialization, Anti-Infectives. Responsibilities include developing launch plans and exploring various commercialization approaches
for our Anti-Infective portfolio, including three launches anticipated over the next two years. You will lead in a matrix environment of cross-functional
stakeholders and closely collaborate with the DTC Lead for Anti-Infectives, who will focus on brand promotion and media deployment across the portfolio.
This role also has a strong external focus to identify and explore innovative channels and commercialization approaches.
This is a highly visible and strategically important role for GSK as we re-enter the anti-infective market establishing a broad franchise in an environment
where Patient Journeys become more fluid and complex, both online and offline. We are looking for an inspiring commercial leader who can seamlessly
interact with Senior Stakeholders across the US, Global and external market.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
* Deeply understand Patient Journeys for portfolio assets and develop strategies to address pain points
* Build new commercialization channels for the Anti-Infectives portfolio, incl. Direct-to-Patient (DTP)
* Assume business ownership of the DTP platform, incl. risk management plans
* Create launch plans for selected assets in the Anti-Infectives portfolio, ensuring successful execution and market entry.
* Drive external partnerships and innovation initiatives, including identification and testing of new opportunities to market our products differently
and maximize our ambition.
* Set direction and ensure strategic alignment across functional stakeholder groups · Maintain detailed understanding of disease and competitive marketplace · Foster an environment of innovation, inclusion,
challenge, trust and development
Why You?
Basic Qualifications:
* BS/BA with 6-8 years of marketing or relevant commercial experience, including a minimum of 3 years in US biopharma marketing.
* Ability to be in-office consistently 2-3 days per week (Philadelphia, PA or Durham, NC).
* Ability to travel 25%
Preferred Qualifications:
* BS/BA with 8-10 years of marketing or relevant commercial experience, including a minimum of 4 years in US biopharma marketing.
* Experience in US healthcare anti-infectives brand marketing.
* Consulting and/or Business Development experience.
* Experience in direct people management; and/or significant enterprise/matrix leadership.
* Strong interpersonal skills and ability to build effective working relationships in a matrix environment.
* Proven decision-making, strategic thinking, problem-solving, and oral/written communication skills.
* Experience working with global launch/marketing teams.
* Demonstrated broad commercial experience, including:
* Brand lifecycle management
* Product launch; Category creation
* Customer insight, Messaging, campaign, creative development
* Category / disease and product strategy development
* Tactical plan development/execution, including integrated channel mix
* Understanding of channels, pricing, and market access strategies
* Drives market and brand opportunity analysis and develops actionable brand insights
* Recognizes trade-offs and makes adjustments as needed; prioritizes short / long-term needs
* Demonstrated sense of ownership for the shared success of the team and asset · Thrives in a fast-paced, dynamic, competitive environment · Competitive mindset; feels driven to conquer uncharted territory.
* Strong written and verbal communication skills
* Strong business & scientific acumen, learning agility
* Ability to influence at all levels & build strong relationships in a matrix environment
* Experience influencing without direct authority across cross-functional teams
* Demonstrated success in developing & executing brand marketing plans
* Ability to define, track, analyse key performance measures and make data-driven decisions
* Financial acumen and P&L mindset
* Strategy development, particularly in complex and novel environments
* Ability to prioritize, pivot, and manage multiple projects simultaneously
This role is hybrid, with an expectation of 2-3 days per week in the office (Philadelphia, PA or Durham, NC).
We encourage you to apply if you are ready to take on a leadership role in a fast-paced, innovative environment. Join us in our mission to make a difference in patients' lives and get ahead of disease together.
#GSKCommercial
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at ************** (US Toll Free) or *************** (outside US).
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************
Auto-ApplyDirector, External Expert Strategy & Engagement
Director of strategy job in Raleigh, NC
The Director, External Expert Strategy & Engagement is a critical role responsible for defining, standardizing, and overseeing the company's global strategy for engaging a broad spectrum of external stakeholders. This includes Key Opinion Leaders (KOLs), Digital Opinion Leaders (DOLs), Payers/Access Stakeholders, Academic/Integrated Health Systems, Patients/Caregivers, and Patient Advocacy Groups. The role is accountable for establishing the governance, process clarity, and technological infrastructure necessary to ensure coordinated, high-value, and non-transactional interactions across all functional areas, distinguishing tactics based on the asset lifecycle stage (Early vs. In-line). This position reports directly to the Executive Director of External Engagement and Field Excellence.
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**Key Responsibilities:**
**Strategic Governance and Accountability**
+ Establish clear accountability and process ownership for all external expert engagement activities, defining roles and responsibilities across the Medical Affairs (GMA) function to address the current pain point of limited clarity on accountabilities and responsibilities.
+ Develop and implement a standardized global strategy for external engagement that distinctly tailors objectives based on asset lifecycle (e.g., Early Asset engagement must focus on obtaining input from KOLs and Payers on trial design and clinical/economic value).
**System and Data Management**
+ Coordinate with stakeholder engagement liaisons (from GMA, Commercial, Clinical Development, Market Access, Patient Advocacy and Stakeholder Management, Corporate Communications, and Government Affairs) and IT to migrate multiple, overlapping stakeholder lists.
+ Drive process adherence for the consistent upkeep and governance of the centralized external stakeholder list, ensuring the database accurately tracks engagement across all categories of stakeholders (e.g., Patients/Caregivers, Academic Systems, Digital Opinion Leaders).
+ Champion the use of the centralized system to track all medical expert interactions, contact attempts, and strategic insights captured.
**Coordination and Best Practices**
+ Facilitate connections between the designated primary stakeholder lead contact and any internal team member seeking subsequent outreach to prevent multiple concurrent communications and requests.
+ Encourage and mandate best practices for GMA preparation before any stakeholder outreach, ensuring all engagement is high-quality and strategically aligned.
+ Partner with the Training team to develop standardized training and resources for internal teams on proper engagement protocols, compliance guidelines, and use of the centralized Veeva system, highlighting the specific goals for engaging each stakeholder group.
+ Collaborate with Global Training Lead to coordinate any needed training on external engagement processes and/or capabilities.
+ Consider technology and AI to support workflow improvement.
**Qualifications:**
**Education and Experience:**
+ Advanced scientific or clinical degree is required (PharmD, MD, PhD, or equivalent).
+ Minimum of 8 - 10 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 5 years in Global Medical Affairs, Strategic Operations, or an equivalent function focused on External Expert/KOL Engagement.
+ Proven experience in designing, implementing, and managing global engagement processes across multiple therapeutic areas and across different asset lifecycle stages.
+ Demonstrated success in leading a complex cross-functional project (e.g., system migration, process standardization) involving IT and multiple business units.
**Skills and Competencies:**
+ Exceptional ability to drive process governance and change management across a global matrix organization.
+ Superior Stakeholder Management and influencing skills, capable of gaining consensus and driving compliance among diverse functional leaders (Commercial, Clinical, Global Medical Affairs).
+ Strong technological acumen with proven experience working with Veeva or similar management platforms for centralized data management.
+ Excellent communication and presentation skills, with the ability to articulate the strategic value of coordinated external engagement to senior executive leadership.
+ Motivated and solution-oriented, with a clear focus on simplifying complex processes for end-users.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Director, Regulatory Affairs - Clinical Strategy
Director of strategy job in Raleigh, NC
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As 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. For more information, visit ****************
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief 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. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities. The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.
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
Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports
CORE Responsibilities
Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2) NDA submissions
Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths
Qualifications and Education Requirements
10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
Bachelor's degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)
#LI-Hybrid
Physical & Mental Requirements:
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to sit for long periods of time
While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
May occasionally climb stairs and/or ride elevators
The employee must occasionally lift and/or move up to 25 pounds
Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
Other miscellaneous job duties as required
Benefits We Offer:
Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
Fuel Your Success: *
Sales Only*
- We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *
Excludes Sales, Manufacturing, and some Operations positions*
Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.
Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here.
The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
Auto-ApplyAssociate Director/Director Strategy, Real World Evidence and Late Phase
Director of strategy job in Morrisville, NC
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* We 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.
* We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Responsibilities
* Act as a SME in RW study design and strategy across Syneos Health
* Develop innovative Real World Data (RWD)-based solutions
* Enhance growth, identify opportunities, and drive sales for the RWLP Business Unit.
* Work with current and potential clients to identify their RWE needs and serve as liaison between sponsor and internal Syneos teams.
* Work closely with RWLP operations teams to determine project delivery requirements and ensure customer satisfaction post-delivery. Work closely with Business Development to identify and generate early engagement and potential sales opportunities and continuously manage sales enablement collateral,
* Serve as go-to point person both internally and externally for resolution of conflicts, setting proper expectations, escalation, etc. Document all contacts in Salesforce for tracking and metrics.
* Provide accountability, preparation and leadership for customer ballparks, Request for Information (RFIs), Request for Proposals (RFPs), presentations, proposal defenses and bid defense meetings (BDMs)
* Analyze department sales data and overall opportunities and present to leadership.
* Coordinate the necessary medical/scientific input from outside experts/consultants/advisors.
* Represent Syneos Health by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and publishing scientific or industry related articles
* Participate in the development of Standard Operating Procedures (SOPs), medical/scientific tools, training, staffing requirements, etc. where required.
* Identify and oversee the delivery of RWLP vendor/partner services, focusing on the development and integration of service offerings that best align with operational needs.
* Contribute account-level insights to identify and address operational risks and areas for process improvement within the RWLP Business Unit .
* May travel up to 40% of the time.
* Lead or actively participate in departmental, project, leadership, and other initiatives.
QUALIFICATION REQUIREMENTS (please indicate if 'preferred')
* BA/BS in the life sciences, nursing degree, or equivalent education or equivalent related experience, with experience in the development of scientific studies and data analysis. PhD preferred.
* Strong methodologic background across various RW study designs and methods
* Strong RWD background and knowledge of US and ex-US RWD sources and their fitness for different study types
* Background in senior-level role in pharma or CRO preferred (but not required); therapeutic expertise in Oncology, Cell & Gene Therapy, Rare Disease, Genomics, or Immunology preferred
* Must have spent some time actively managing clinical and RW research projects across functional areas.
* Thorough knowledge of Regulatory requirements andthe clinical development process
* Flexibility, the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines, and deliver high quality work in a dynamic environment is essential.
* Requires strong presentation, documentation, interpersonal skills, and a team-oriented approach.
* Exceptional influencing and networking skills
* Must be comfortable in a customer-facing role while also able to provide technical expertise.
* Minimum of five (5) to seven (7) years of RWLP Experience in a CRO, pharmaceutical, or Biotechnology Company for Director (more experience required for Senior Director role)
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
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Additional Information
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
JOB SUMMARY The Associate Director/Director, Real World Evidence (RWE) Strategy will serve as a Subject Matter Expert (SME) of the RWE domain and will develop Real World (RW) solutions for our clients in partnership with the Syneos Health RW and Late Phase (RWLP) operations team, Epidemiology team, and other SMEs. The primary responsibility of this role is to proactively engage with sponsors and external partners to drive new business--with the overarching goal of achieving target revenue and profitability for the LP Business Unit while exceeding customer expectations. This role is characterized by high client interaction, emphasizing the importance of cultivating strong client relationships.
Senior Brand Manager -MMC
Director of strategy job in Greensboro, NC
**City** Greensboro **Role Type** Permanent **WHO WE ARE** ITG Brands is the third-largest tobacco company in the USA with offerings of some of the most well-known cigarette, cigar, and e-vapor brands. As a member of the globally recognized Imperial Brands PLC family, we are a forward-thinking partner with operational integrity.
ITG Brands is committed to putting consumers at the center of what we do, while creating an innovative workplace where inclusion, creativity, and bold thinking drive progress. This empowers us to bring our true selves to work, to collaborate more effectively through showing our passion and being confident to bring new ideas to the table.
We are not afraid to seize opportunities and make things happen - both individually and collaboratively. We strive to exceed expectations by seeing things differently and doing things differently. This truly is a place where we all share a challenger mindset which drives our success.
**What You Will Do**
- JOB SUMMARY
Drive development and execution of dynamic and creative brand marketing programs, ensuring assigned brand(s) achieve corporate volume and brand contribution objectives by coordinating with brand management and working cross-functionally with key business areas. Serve as primary source for all matters pertaining to assigned brand(s), brand consumers, competition, and the marketplace. Champion innovation in the coordination of brand(s) volume forecast and updates and skillfully monitor the success of brand(s) performance against plan. Uphold Company culture and values, lead by example to instill behaviors in day-to-day operations and empower team members.
- WHAT YOU WILL DO
_(This list is not exhaustive and may be supplemented as necessary by the Company)_
+ Understand the target consumer and consumer journey. Craft well-reasoned creative briefs for agency partners centered on insights and brand objectives. Deliver effective and persuasive consumer communications for the assigned brand portfolio(s), working with internal and external partners to ensure creative objectives that drive purchase intent and appeal are met.
+ Ensure that the product blends for all brand packing styles are competitive in the marketplace by working with multiple business areas to test products against action standards, recommending changes to Leadership, as needed.
+ Work with category leader to develop short term tactical plans and long-term strategic plans to align brand(s) objectives to overall business objectives.
+ Brief and guide creative executions for brand(s). Recommend business building programs to Leadership by identifying opportunities that will generate incremental volume for the company. Review all executions with Leadership and ensure revisions to all consumer communications are accurate and deadlines met.
+ Provide input on the development of the marketing plans and execution by identifying the key issues and strategies for the plan and overseeing the implementation of the plan. Recommend adjustments to the plan based on volume, share and profit performance objectives, changes in competitive activities or overall changes in the marketplace.
+ Develop the annual volume budget for brand(s) by analyzing sales and competitive trends. Monitor industry trends, brand performance trends and competitive influences and recommend changes to volume forecasts based on actual sales volume performance compared to the budget and the production forecast. Monitor brand spending to ensure it does not exceed plan by analyzing actual costs versus the budget and recommending adjustments.
+ Build collaborative relationships with cross-functional teams and agency partners to develop brand-building strategies, campaigns, initiatives, activations, and events to ensure alignment with short and long term commercial, category, and brand plan objectives while integrating US requirements, and insights to execute against defined global initiatives.
+ Perform other job-related duties as assigned.
**Qualifications**
- REQUIRED MINIMUM QUALIFICATIONS:
Education and Experience:
+ Bachelor's degree in business administration, Marketing, or related field of study
+ 8+ years relevant work experience in Brand Marketing, Consumer Marketing (D2C), Performance Marketing, Customer Marketing (B2B), etc.
+ In lieu of Bachelor's degree, 10+ years of relevant work experience
+ Experience in consumer-packaged goods company, creative agency, etc.
+ Must be 21 years of age or older
Knowledge of:
+ Advanced proficiency with Microsoft Office (Outlook, Word, Excel, & PowerPoint) and Microsoft Teams
+ Regulated products such as alcohol, tobacco, energy drinks, etc.
+ Consumer packaged goods
+ Consumer marketing
Skilled in:
+ Verbal and written communication
+ Attention to detail
+ Problem/situation analysis
+ Effective time and task management
+ Multitasking capabilities
+ Flexibility and adaptability
+ Project management
Ability to:
+ Strategically plan and implement comprehensive marketing programs
+ Dissect business practices and needs to develop and communicate ideas
+ Communicate to a broad and diverse audience
+ Maintain effective working relationships
+ Demonstrate critical thinking
+ Prioritize assignments, workload, and manage time accordingly
+ Work with business partners in different time zones
+ Travel domestically
- PREFERRED QUALIFICATIONS:
Education and Experience:
+ Master's degree in Business Administration, Marketing, or related field of study
+ 2+ years of supervisory experience
**Work Environment and Physical Demand**
+ Requires moderate physical effort. Occasionally lifts or moves objects up to 10 lbs.
+ Walks, sits, or stands for extended periods
+ Requires prolonged machine operation including vehicle, computer, and keyboard equipment
_This is intended to be generic in nature and describe the essential functions of the job. It is not necessarily an exhaustive list of all duties and responsibilities. The essential duties, functions and responsibilities, and overtime eligibility may vary based on the specific tasks assigned to the position._
**What We Offer**
- Competitive benefits package that includes medical/dental/vision/life insurance/disability plans
- Dollar for dollar 401k match up to 6% and 5% annual company contribution
- 15 Company-paid holidays
- Generous paid time off
- Employee recognition and discount programs
- Education assistance
- Employee referral bonus program
- Hybrid workplace - remote / in office
- Summer hours
- Casual dress policy Monday through Friday
**Applicant Information**
This describes the essential functions of the job at the time the was created, but it is not an exhaustive list of tasks, duties and responsibilities. In addition, the position may evolve or change over time and such changes may not be reflected in the job description until it is next updated.
**ITG Brands and ITG Cigars provides equal employment opportunities.** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. If you have a concern about discrimination in the application or hiring process or you need an accommodation based on religion, disability or pregnancy in the application or hiring process, please contact us at ******************************* .
**SHARE THIS JOB**
The posting for the position for which you are applying highlights key aspects of the position only. It is not a complete description of the position.
All candidates must consent to an independent investigation of their background, references, past employment, education, criminal record, and drug screening. Results of such background checks will be reviewed on a case-by-case basis, giving consideration to the nature of the information reported and its relevance to the specific job being sought before a decision is made using this information.
ITG Brands and ITG Cigars provides equal employment opportunities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. If you have a concern about discrimination in the application or hiring process or you need an accommodation based on religion, disability or pregnancy in the application or hiring process, please contact us at ******************************* (Talen%74Acquisition%40%69t%67b%72ands.%63om) .
We collect personal information from you in connection with your application for employment with ITG Brands or ITG Cigars. For more information, please see our Privacy Policy (****************************************** . If you are a job applicant from California, additional information can be found on our California Applicant Privacy Notice (******************************************************* . If you have questions, contact us atprivacy@itgbrands.com (priv%61%63y@i%74gb%72ands.co%6D) .
Director, Data Analytics
Director of strategy job in Raleigh, NC
Drives data analytics and optimization of Light and Wonder's Charitable gaming business - Grover Gaming. This role will work directly with the Grover Gaming leadership to maximize game performance for our customers through the use of data and analytics. Responsible for identifying, developing and executing on all opportunities for all areas of data analytics (game performance, product, market/census, etc.) to ensure the business is equipped to make informed, data-based decisions.
Essential Job Functions:
Lead and build out the Data Analytics function to develop new data sources, produce new analysis, and provide forward-looking guidance to our internal and external customers.
Develop an analytically driven optimization program that proactively manages Grover Gaming game performance across all customers.
Manages a data analyst to help support the broader business in all data analytics objectives.
Assist in the development of a funnel management process where applicable, to help drive visibility and facilitate a monthly budget/recurring forecast updates.
Provide input as necessary into all forecasting processes based on market trends, customer feedback, game performance, appropriate level of discounting and donations at the customer level.
Research competitor pricing, performance and product lines.
Create executive level presentations and customer-facing materials that clearly outlines key product strategies, customer pitches, and KPI updates (as needed)
Build productive collaboration and communication.
Learn all portfolio products at a detailed level.
Understand regional market dynamics and competitive products.
Travel to markets as needed.
Qualifications:
Training and/or Experience
Technical skills
Databases/ Programming Languages: Python, SQL, SAS
Machine Learning Techniques: Classification, Regression, Time Series, Clustering
Cloud/ Dev Ops: AWS Lambda, S3, Athena
BI/ Visualization Tools: Tableau, QuickSight
Ability to effectively work with cross-functional teams
Possess excellent analytical, strategic, and presentation skills
Experience in working with big data environments and multiple databases
Experience in financial modeling and analysis
Strong ability to mine data and compile the information into actionable insights
Knowledge of the Gaming Industry and regulations preferred
Strong problem-solving skills
Knowledge, Skills and Abilities:
Possesses high integrity and exceptional work ethic.
Fosters mutual trust and respect and is an excellent team player.
Focused on team success. Works well in a team environment.
Assists team members in all areas to achieve success and retrospectively provides feedback for continuous improvement.
Possess the ability to identify, analyze, and resolve problems logically and systematically meets challenges consistently and confidently with energy and drive.
Motivated by results, urgency and personal commitment.
Able to work effectively in a highly complex matrix environment, with a proven ability to influence without formal authority and achieve results through people.
Understands the link between excellence in data acquisition/warehousing/insights, and how to leverage this as a competitive advantage in the marketplace.
Applies effective communication techniques, engages in focused dialogue, and demonstrates good listening skills.
Strong interpersonal and relationship-building skills.
Possess strong leadership capabilities and skilled in driving development of employees.
Outstanding oral, written and communication skills with the ability to present to small and large groups including Global Executives and deal with unexpected questions and challenges while presenting.
Excellent and proven project management skills.
Education:
Masters' Degree in Analytics, Statistics, Mathematics or Business Related
7-10 Years of experience in the Gaming Industry, Finance, Sales, Consumer products
Physical Requirements:
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand, walk, bend, use hands, operate a computer, and have specific vision abilities to include close and distance vision, and ability to adjust focus working with computer and business equipment.
Work Conditions:
The work conditions are representative and typical of similar jobs in comparable organizations
We are Grover Gaming!
At Grover Gaming, we build entertainment experiences that excite and inspire. From innovative electronic games to mission-driven partnerships, our work powers charitable gaming across the country, helping nonprofits fund the causes that matter most. We believe in doing what you love and doing it with purpose. Our team of innovators, creators, and problem-solvers is shaping the future of charitable gaming. Together, we are building more than games, we are #playingitforward by building community, impact, and opportunity.
Why Grover Gaming?
• Join a passionate team in one of the most exciting sectors of the gaming industry
• Be part of a mission-driven organization that supports charitable causes
• Competitive salary and benefits
• Opportunities for advancement and growth
• A culture built on innovation, integrity, and service
Don't meet every requirement? Studies show that women and people of color are less likely to apply for jobs unless they meet every single qualification. At Grover Gaming, we know that creativity, passion, and different perspectives are what make our games and impact truly special. We welcome people from all backgrounds and experiences. If this role excites you but your experience doesn't match every qualification, we still want to hear from you. You could be exactly the teammate we need!
#LI-AM1
Qualifications
Light & Wonder is an Equal Opportunity Employer and does not discriminate against applicants due to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. If you'd like more information about your equal employment opportunity rights as an applicant under the law, please click here for EEOC Poster.
Auto-ApplyDirector, Data Analytics
Director of strategy job in Raleigh, NC
Drives data analytics and optimization of Light and Wonder's Charitable gaming business - Grover Gaming. This role will work directly with the Grover Gaming leadership to maximize game performance for our customers through the use of data and analytics. Responsible for identifying, developing and executing on all opportunities for all areas of data analytics (game performance, product, market/census, etc.) to ensure the business is equipped to make informed, data-based decisions.
Essential Job Functions:
* Lead and build out the Data Analytics function to develop new data sources, produce new analysis, and provide forward-looking guidance to our internal and external customers.
* Develop an analytically driven optimization program that proactively manages Grover Gaming game performance across all customers.
* Manages a data analyst to help support the broader business in all data analytics objectives.
* Assist in the development of a funnel management process where applicable, to help drive visibility and facilitate a monthly budget/recurring forecast updates.
* Provide input as necessary into all forecasting processes based on market trends, customer feedback, game performance, appropriate level of discounting and donations at the customer level.
* Research competitor pricing, performance and product lines.
* Create executive level presentations and customer-facing materials that clearly outlines key product strategies, customer pitches, and KPI updates (as needed)
* Build productive collaboration and communication.
* Learn all portfolio products at a detailed level.
* Understand regional market dynamics and competitive products.
* Travel to markets as needed.
Qualifications:
Training and/or Experience
* Technical skills
* Databases/ Programming Languages: Python, SQL, SAS
* Machine Learning Techniques: Classification, Regression, Time Series, Clustering
* Cloud/ Dev Ops: AWS Lambda, S3, Athena
* BI/ Visualization Tools: Tableau, QuickSight
* Ability to effectively work with cross-functional teams
* Possess excellent analytical, strategic, and presentation skills
* Experience in working with big data environments and multiple databases
* Experience in financial modeling and analysis
* Strong ability to mine data and compile the information into actionable insights
* Knowledge of the Gaming Industry and regulations preferred
* Strong problem-solving skills
Knowledge, Skills and Abilities:
* Possesses high integrity and exceptional work ethic.
* Fosters mutual trust and respect and is an excellent team player.
* Focused on team success. Works well in a team environment.
* Assists team members in all areas to achieve success and retrospectively provides feedback for continuous improvement.
* Possess the ability to identify, analyze, and resolve problems logically and systematically meets challenges consistently and confidently with energy and drive.
* Motivated by results, urgency and personal commitment.
* Able to work effectively in a highly complex matrix environment, with a proven ability to influence without formal authority and achieve results through people.
* Understands the link between excellence in data acquisition/warehousing/insights, and how to leverage this as a competitive advantage in the marketplace.
* Applies effective communication techniques, engages in focused dialogue, and demonstrates good listening skills.
* Strong interpersonal and relationship-building skills.
* Possess strong leadership capabilities and skilled in driving development of employees.
* Outstanding oral, written and communication skills with the ability to present to small and large groups including Global Executives and deal with unexpected questions and challenges while presenting.
* Excellent and proven project management skills.
Education:
* Masters' Degree in Analytics, Statistics, Mathematics or Business Related
* 7-10 Years of experience in the Gaming Industry, Finance, Sales, Consumer products
Physical Requirements:
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand, walk, bend, use hands, operate a computer, and have specific vision abilities to include close and distance vision, and ability to adjust focus working with computer and business equipment.
Work Conditions:
* The work conditions are representative and typical of similar jobs in comparable organizations
We are Grover Gaming!
At Grover Gaming, we build entertainment experiences that excite and inspire. From innovative electronic games to mission-driven partnerships, our work powers charitable gaming across the country, helping nonprofits fund the causes that matter most. We believe in doing what you love and doing it with purpose. Our team of innovators, creators, and problem-solvers is shaping the future of charitable gaming. Together, we are building more than games, we are #playingitforward by building community, impact, and opportunity.
Why Grover Gaming?
* Join a passionate team in one of the most exciting sectors of the gaming industry
* Be part of a mission-driven organization that supports charitable causes
* Competitive salary and benefits
* Opportunities for advancement and growth
* A culture built on innovation, integrity, and service
Don't meet every requirement? Studies show that women and people of color are less likely to apply for jobs unless they meet every single qualification. At Grover Gaming, we know that creativity, passion, and different perspectives are what make our games and impact truly special. We welcome people from all backgrounds and experiences. If this role excites you but your experience doesn't match every qualification, we still want to hear from you. You could be exactly the teammate we need!
#LI-AM1
Qualifications
Light & Wonder is an Equal Opportunity Employer and does not discriminate against applicants due to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. If you'd like more information about your equal employment opportunity rights as an applicant under the law, please click here for EEOC Poster.
Director Reporting & Data Analysis-Cost of Care Analytics
Director of strategy job in Durham, NC
Director, Reporting & Data Analysis - Cost of Care Analytics Location: This role requires associates to be in-office 3 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. Alternate locations may be considered.
Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law.
The Director of Reporting & Data Analysis-Cost of Care Analytics is a strategic leader responsible for advancing analytics capabilities to drive insights and decisions that improve cost of care performance. This role oversees a high-performing analytics organization, aligning resources, tools, and methodologies to deliver actionable intelligence that supports both business unit objectives and enterprise-wide healthcare affordability strategies.
How You Will Make an Impact
* Provides visionary leadership in building and motivating a data-driven analytics team focused on cost of care insights.
* Directs the development of advanced reporting, analytics, and forecasting to identify key cost drivers, efficiency opportunities, and performance improvement levers.
* Partners with senior business leaders to translate analytics into strategy, ensuring insights directly inform cost management, operational decision-making, and value-based initiatives.
* Develops organizational capabilities through coaching, training, and effective talent development practices.
* Ensures accuracy, timeliness, and relevance of analytics deliverables across all supported business areas.
* Builds strong relationships with stakeholders at all levels, serving as a trusted advisor on cost-of-care performance and analytics.
* Manages fiscal responsibilities for assigned budgets, ensuring efficient use of resources.
* Establishes and enforces consistent policies, practices, and methodologies for reporting and data analysis.
* Leads cross-functional project management efforts, ensuring seamless collaboration across finance, clinical, and business teams.
* Communicates complex technical and analytical findings in clear, actionable, business terms.
Minimum Qualifications:
* Requires a BA/BS degree and a minimum of 10 years of experience leading project teams, or any combination of education and experience, which would provide an equivalent background.
Preferred Skills, Capabilities, and Experience:
* Deep knowledge of information management technologies and modern analytics platforms.
* Demonstrated track record of developing and executing analytics strategies that impact cost of care or financial performance.
* Experience leading multi-disciplinary teams and managing large, complex data initiatives.
* Strong understanding of healthcare economics, medical cost drivers, and affordability levers.
* Proven ability to influence and collaborate with executive leaders and external partners.
* Exceptional communication skills, including facilitation, consultation, and executive-level storytelling.
* Prior leadership in an analytics, finance, or healthcare environment with demonstrated impact on organizational performance.
* Actuarial, Economics or Finance background preferred.
* Experience Identifying medical cost drivers and mitigation factors.
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.
Auto-ApplyDirector, R&D Analytical Sciences
Director of strategy job in Durham, NC
Job Purpose: This position contributes to the Company's success by providing oversight and execution of method development, validation and formulation support for the development of topical drug products.
Summary of Key Responsibilities: • Lead and provide primary oversight for execution of analytical method development, validation and formulation development support
• Manage multiple projects simultaneously and communicate with study sponsors and business partners
• Review and approve project timelines, cost and resource assumptions
• Provide technical expertise for method development/validation efforts of multiple projects and perform high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards
• Coordinate with other departments to optimize resources, streamline laboratory functions and operations and improve quality
• Coordinate with Quality Assurance Department to identify, initiate and implement corrective and preventive actions
• Approve protocols, instrument qualification protocols, pharmaceutical development reports, SOPs, etc.
• Lead, review and trend laboratory investigations
• Maintain a GMP-compliant analytical laboratory and safe working environment
• Outline career paths for all team members by establishing goals, providing feedback, mentoring and training
Required Qualifications and Skills:
• B.S. / M.S. in chemistry, pharmaceutical sciences, or related discipline with at least 15 years' related experience, 7-10 years' related experience preferred
• Demonstrated management and leadership experience with a specific focus on driving projects to deliverables and growing revenue
• Experience with method development for semi-solid products preferred
• Experience in topical product development/GMP laboratory setting preferred
• CRO experience preferred
• Demonstrated experience developing and validating assay methods using HPLC
• Working knowledge of regulatory requirements including cGMP, FDA, CFRs, ICH and USP
• Technically capable of determining the root cause of a problem, offering potential solutions and working with others to correct the problem
• Works toward common goals by supporting, encouraging and sharing information with colleagues, both internal and external
• Able to confer with others to reach a resolution, exploring alternatives and positions to attain outcomes that gain the support and acceptance of all parties
• Responds to changing needs of the business, and personally identifies and champions new ideas for improvement and growth
• Speaks writes, listens and presents information in a logical and articulate manner
• Strong technical writing skills
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
Auto-ApplyRates and Regulatory Strategy Manager
Director of strategy job in Raleigh, NC
Important Application Submission Information In order to ensure your application is successfully received before the job posting expires, please submit your application by 11:59 PM on Tuesday, January 6, 2026 More than a career - a chance to make a difference in people's lives.
Build an exciting, rewarding career with us - help us make a difference for millions of people every day. Consider joining the Duke Energy team, where you'll find a friendly work environment, opportunities for growth and development, recognition for your work, and competitive pay and benefits.
Position Summary
Able to lead major work streams and keep process on track to successful completion (i.e. rider filings, rate cases, etc) in regulatory filings. Able to provide guidance to others (both internal and external to the group), teach and develop other employees, and delegate work as appropriate. Building leadership qualities across multiple disciplines and departments effectively. Has a grasp on industry issues and emerging rules and proactively addresses how these issues may affect regulatory processes and suggests proper ratemaking treatment. Develops good working relationships and develops strong relationships with internal and external customer groups (including regulators). Proficient in conflict management. Listens attentively and able to communicate both orally and in written form proficiently. Able to present ideas and concepts clearly to broad groups. Capable of providing live testimony in front of utilities commissioners and parties intervening in various proceedings.
Responsibilities
* Annual fuel rider filings & supporting other recovery mechanisms (e.g., special contracts, development of recovery strategy for new programs)
* Developing testimony to support annual fuel rider filings in North Carolina and South Carolina
* Responding to a large volume of data requests from outside parties to support the annual fuel rider filings
* Reviewing monthly fuel filing information prepared by other team member(s)
* Regulatory filings, compliance activities and shared service rate work
* Regulatory strategy analysis, reporting and support
* Leading and resolving strategic company or jurisdictional initiatives
* Ability to perform detailed analysis and provide high-quality filings with attention to detail
* Ability to grasp the big picture and reach appropriate conclusions from detailed analysis
* Ability to communicate complex concepts clearly and concisely for management
* Ability to deal with ambiguity
* Ability to reach compromise with others, both internal and external
* Ability to develop strong rapport with regulators
Basic/Required Qualifications
* Bachelors degree in Business, Finance, Mathematics, Accounting or other related degree AND eight (8) years minimum required related work experience
Additional Preferred Qualifications
* Certified Management Accountant
* Certified Public Accountant
* Chartered Financial Analyst
* Employees at this level are able to perform proficiently at the Lead Rates & Regulatory Strategy Analyst requirements and is demonstrating the ability to perform at the Rates & Regulatory Strategy Manager requirements.
Working Conditions
* Hybrid Mobility Classification - Work will be performed from both remote and onsite locations after the onboarding period. However, hybrid employees should live within a reasonable daily commute to a Duke Energy facility
* 3 days in office; flexible
#LI-VF1
#LI-Hybrid
Travel Requirements
5-15%
Relocation Assistance Provided (as applicable)
No
Represented/Union Position
No
Visa Sponsored Position
No
Please note that in order to be considered for this position, you must possess all of the basic/required qualifications.
Privacy
Do Not Sell My Personal Information (CA)
Terms of Use
Accessibility
Auto-ApplyPrivate Client Banker - Oberlin Rd - Raleigh, NC
Director of strategy job in Raleigh, NC
You have a passion for taking care of our customers and employees and making them feel welcomed and valued by building lasting relationships, doing the right thing, exceeding expectations and having a strong commitment to diversity and inclusion. Here at Chase, you will have the opportunity to help people experience our Customer Promise -- helping people make the most of their money so they can make the most of their lives by providing education and advice tailored to suit their financial needs.
As a Private Client Banker in Branch Banking, you are the main point of contact for a select group of Chase's affluent clients as well as other customers in the Branch. You will manage their complete banking relationship across the company, utilizing a proactive and disciplined approach to generate growth in their balances. You will help acquire new clients by actively soliciting referrals and developing internal and external sources.
Job responsibilities
Shares the value of Chase Private Client with clients that may be eligible
Actively manages their banking relationship through an advice-based approach, ensuring each client receives the best products and services for their needs
Partners with Specialists (Private Client Advisors, Mortgage Bankers and Business Relationship Managers) to connect customers to experts who can help them with specialized financial needs
Makes lives of clients more convenient by sharing and setting up self-service options to access their accounts 24 hours a day/ 7 days a week
Adheres to policies, procedures, and regulatory banking requirements
Required qualifications, capabilities, and skills
Demonstrated success using a value-added, relationship-oriented approach to acquire and deepen client relationships
1+ year Branch Banking Banker or equivalent experience in financial services, with verifiable success in new client acquisition, cultivating, and maintaining customer relationships and revenue generation
Beginning Oct. 1, 2018, if you are not currently registered, the Securities Industry Essential (SIE) exam, FINRA Series 6/7, state registration (including 63 or 66 if required) and Life licenses are required - or must be successfully completed within 180 days of starting the role
Compliance with Dodd Frank/Truth in Lending Act*
High school degree, GED, or foreign equivalent
Adherence to policies, procedures, and regulatory banking requirements
Ability to work branch hours, including weekends and some evenings
Preferred qualifications, capabilities, and skills
Excellent communication skills
College degree or military equivalent
Experience cultivating relationships with affluent clients
Strong team orientation with a commitment of long-term career with the firm
Dodd Frank/Truth in Lending Act
This position is subject to the Dodd Frank/Truth in Lending Act qualification requirements for Loan Originators. As such, an employment offer for this position is contingent on JPMC's review of your criminal conviction history, credit report, information available through NMLS, and any other information relevant to a determination by JPMC that you demonstrate financial responsibility, good character, and general fitness for the position. Note that any felony conviction within the last seven years will disqualify you from consideration for this position. Your continued employment in this position would be contingent upon compliance with Truth in Lending Act/Dodd Frank Loan Originator requirements.
In addition, this position requires National Mortgage Licensing System and Registry (NMLS) registration under the SAFE Act of 2008. As such, upon active employment with JPMorgan Chase, you will be required to either register on NMLS, or to update your existing registration as necessary to grant access to and reflect your employment with JPMorgan Chase. Your continued employment in this position with JPMorgan Chase is contingent upon compliance with the SAFE Act, including successful registration immediately after your start date, and timely completion of annual renewal and required updates thereafter.
Any information obtained during the registration, update, and renewal processes or through NMLS notifications may impact your employment with the firm. Any of the completed information you provide during the Chase on-line application process may be transferred, on your behalf, to NMLS by JPMorgan Chase. Please carefully review the information you provide to Chase for accuracy and consistency and with any current NMLS record, if applicable, before submitting. Further information about NMLS and registration requirements of registration can be found at: **************************************************************************
Auto-ApplyProgram Manager - Strategic Planning & Execution - GMPD
Director of strategy job in Raleigh, NC
In Cardinal Health Medical Segment, we're developing innovative products and services that are mission critical to healthcare. To enable this mission, the Program Manager, Strategic Planning and Execution - Global Medical Products & Distribution (GMPD) will be responsible for leading disciplined strategic planning process across the segment, bringing to bear both thought and project/program leadership to create momentum and enable action.
This position reports to the Sr. Director, Strategic Planning - GMPD. The GMPD Strategy & Business Development team develops segment strategy, manages business analytics, and executes strategic plans for both organic and inorganic growth.
This role is ideal for a strategic thinker with strong project management skills, experience in healthcare, and the ability to lead cross-functional teams and deliver complex initiatives. Communication, collaboration, curiosity, and analytical rigor are key to success.
**Responsibilities**
+ **Strategic** **Planning** **and** **Execution** : Assists with long-term and annual strategic planning, tracks quarterly objectives, and manages key projects across business, finance, IT, and other areas. Communicates effectively with cross-functional teams in a matrixed environment.
+ **Program** **and** **Project** **Management** : Leadership of cross-functional teams with meticulous attention to detail and expertise in developing processes and systems for delivering complex, multi-modal solutions with consistent quality. Recognizes key project milestones, interdependencies, tasks, and limitations within large and intricate programs and projects.
+ Manage multiple projects, prioritize tasks, and meet deadlines through effective project management, problem solving, conflict resolution, and stakeholder communication.
+ Collaborate with internal and external partners to mobilize teams and ensure timely project delivery.
+ Identify and resolve issues, develop risk mitigation strategies, and escalate appropriately for successful execution.
+ **Analytical** **Rigor** : Bring structure to problems and intellectual leadership to problem solving; synthesize insights from analysis and ensure credible, actionable recommendations
+ **Financial** **Acumen** : Responsible for budgeting and capital allocation in the context of program management and strategic planning to maximize shareholder value. General understanding of financial performance metrics (i.e. P&L)
+ **Communications** **skills** : Develop rapport and credibility across the organization, promote ideas and proposals persuasively; proactively build clear, concise, strategic presentations/materials.
+ Strong communicator at all organizational levels.
+ Skilled at presenting to executives and handling sensitive information.
+ Anticipates stakeholder needs and clearly conveys program updates and answers anticipatory and impromptu questions.
**Qualifications**
+ Bachelor's degree in related field preferred
+ PMP (Project Management Professional ) Certification a plus
+ 8+ years related work experience preferred
+ Understanding and evidence of employing standard project management tools and approaches across a wide variety of scenarios
+ Knowledge of the healthcare industry
+ Strategic thinker and communicator
+ Cross-functional and cultural champion
+ Strong influence, facilitation, and problem-solving skills
+ Demonstrated strong planning and organizational skills
+ Ability to travel 15%
**Anticipated salary range:** $105,100 - $150,100
**Bonus eligible:** Yes
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with my FlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 12/31/25 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_\#LI-JB1_
_\#LI-Remote_
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (***************************************************************************************************************************
Director, Channel & Alliances
Director of strategy job in Raleigh, NC
Job Description
Who We Are:
Bandwidth, a prior "Best of EC" award winner, is a global software company that helps enterprises deliver exceptional experiences through voice, messaging, and emergency services. Reaching 65+ countries and over 90 percent of the global economy, we're the only provider offering an owned communications cloud that delivers advanced automation, AI integrations, global reach, and premium human support. Bandwidth is trusted for mission-critical communications by the Global 2000, hyperscalers, and SaaS builders!
At Bandwidth, your music matters when you are part of the BAND. We celebrate differences and encourage BANDmates to be their authentic selves. #jointheband
What We Are Looking For:
The Director, Channel & Alliances is responsible for the revenue attainment (sales), coordination, and management of a portion of BAND's Channel Partner Relationships. The company, along with the Director will determine a set of specific strategic partnerships, to build, nurture, and grow market share, that contributes to the company revenue goals, profit, and overall solution positioning for its clients. Partnerships will require frequent checkpoints to insure product compatibility, vision, "fit", and overall value contribution toward the company strategic vision. Emphasis will be on growing business market share and revenue generated from each partnership in support of achieving the company's annual goals (quota) within a given timeframe.
What You'll Do:
Execute tactical and strategic consultative sales initiatives and account plans for existing and new "Sell With" Channel Partnerships in order to achieve the revenue targets as directed by the Business.
Establish and maintain a high level of positive and effective relationships with key partnership contacts and their account and sales teams to enhance sales opportunities and industry "reach".
Through development of the partnership, build a consistent pipeline of partner-referred opportunities during any given quarter and align with the Account Executive team to work those opportunities.
Identify and effectively demonstrate the BAND Products as they relates to the Partner's solutions in order to drive forward a "win together" approach.
Partner with Marketing on coordinating events that can directly or indirectly drive join revenue.
Maintain constant awareness of prospective new/innovative partnership opportunities in various UCaaS and CCaaS market segments, competitor activities, and problems within assigned portfolio base, recognize trends that develop, and make appropriate strategic and tactical sales/marketing recommendations.
Travel, and meet as necessary to maintain a presence with partners, enhance relationship opportunities, attend trade shows, user group events, etc. on a consistent timetable or schedule.
What You Need:
Bachelor's degree or equivalent
Candidates should have a minimum of 5+ years in Channel-driven Sales working with MSPs, SIs, VARs, etc.
Ability to own partnerships operating in a fast-paced, technology environment, responsible for a quota or MBO incentive system.
A proven track record of sales accomplishments and/or above quota achievement
Deep working knowledge of the Telecom Industry Go-to-Market via Channel Partners to unlock direct-to-Enterprise Sales
Strong tolerance for ambiguity; ability to focus and execute in a rapidly changing environment, take charge and make things happen.
The Whole Person Promise:
At Bandwidth, we're pretty proud of our corporate culture, which is rooted in our "Whole Person Promise." We promise all employees that they can have meaningful work AND a full life, and we provide a work environment geared toward enriching your body, mind, and spirit. How do we do that? Well…
100% company-paid Medical, Vision, & Dental coverage for you and your family with low deductibles and low out-of-pocket expenses.
All new hires receive four weeks of PTO.
PTO Embargo. When you take time off (of any kind!) you're embargoed from working. Bandmates and managers are not allowed to interrupt your PTO - not even with email.
Additional PTO can be earned throughout the year through volunteer hours and Bandwidth challenges.
"Mahalo moments" program grants additional time off for life's most important moments like graduations, buying a first home, getting married, wedding anniversaries (every five years), and the birth of a grandchild.
90-Minute Workout Lunches and unlimited meetings with our very own nutritionist.
Are you excited about the position and its responsibilities, but not sure if you're 100% qualified? Do you feel you can work to help us crush the mission? If you answered 'yes' to both of these questions, we encourage you to apply! You won't want to miss the opportunity to be a part of the BAND.
Applicant Privacy Notice
Senior Director, Product Marketing Operations and Competitive Intelligence
Director of strategy job in Raleigh, NC
PagerDuty, Inc. (NYSE:PD) is a global leader in digital operations management. Trusted by nearly half of both the Fortune 500 and the Forbes AI 50, as well as approximately two-thirds of the Fortune 100, PagerDuty is essential for delivering always-on digital experiences to modern businesses.
Join us. (******************************* At PagerDuty, you'll tackle complex problems, collaborate with kind and ambitious people, and help build a more equitable world-all in a flexible, award-winning workplace.
We are seeking a seasoned and insightful people leader to establish and spearhead our Product Marketing Operations and Competitive Intelligence function, reporting directly to the VP, Product Marketing. In this pivotal role, you will lead a dedicated team, driving both major and minor product launches, cultivating robust competitive intelligence, and consistently reporting on progress across all initiatives.
Specifically, evolve, establish and execute product marketing programs and operations related to GTM readiness, to include:
+ **Product Launch process** - Establish, document and maintain product market launch framework, operating model and launch calendar that aligns with development and the field.
+ **Product Launch management** - organize and execute critical product launches, driving the planning and execution of launch activities, events/webinars and ensuring alignment and readiness across all marketing work streams, while coordinating overall readiness with development and field teams.
+ **Competitive Intelligence** - manage a team that builds and runs a competitive intel program that serves as the internal authority on competitive dynamics, equipping sales teams with sharp differentiation, timely insights and effective strategies to win.
+ **Repeatable sales plays** - partner with PMMs, Field, and Enablement stakeholders to define, build and deliver repeatable sales motions to drive annual operating targets (pipeline, billings, net-new logos).
+ **PMM Planning and Coordination** - organize and drive quarterly and yearly planning and operating plans for product marketing, including reporting results to key stakeholders; organize and drive PMM all-hands and leadership meetings and related presentations.
+ **Standards, Best Practices and Consistency** - drives the establishment of consistent templates, frameworks, and constructs for use across the team.
+ **Portfolio-level content and enablement** - drive the planning, delivery and quality of content for any cross-product activity, such as launch content, major event session tracks, and product marketing related enablement programs for sales revenue achievement.
**Basic Qualifications:**
+ 10+ years of experience in B2B marketing, market research, or a related field.
+ 5+ years' experience leading a marketing function, or similar, used to managing multiple projects at one time within established timelines.
+ Proficient in planning and project management skills.
+ Ability to handle individual contributor and detail-oriented responsibilities in addition to people management responsibilities such as guiding, performance managing and mentoring a team.
+ Strong analytical skills and experience in quantitative and qualitative research methods, translating complex data into actionable insights.
+ Delivers results efficiently with a high sense of urgency when applicable.
+ Excellent communication and presentation skills, both written and verbal.
+ Ability to build strong partnerships at all levels of leadership and manage by influence.
+ Seamlessly negotiates and manages conflict.
**Preferred Qualifications:**
+ Experience in high growth companies
+ Software/SaaS/B2B technology industry experience is preferred.
+ Experience in product marketing, specifically experience in managing launches at scale
The base salary range for this position is 180,000 - 304,000 USD. This role may also be eligible for bonus, commission, equity, and/or benefits.
Our base salary ranges are determined by role, level, and location. The range, which is subject to change based on primary work location, reflects the minimum and maximum base salary we expect to pay newly hired employees for the position. Within the range, we determine pay for an individual based on a number of factors including market location, job-related knowledge, skills/competencies and experience.
Your recruiter can share more about the specific offerings for this role, as well as the salary range for your primary work location during the hiring process.
**Hesitant to apply?**
We encourage you to submit your resume even if you don't meet every requirement. We value potential and consider each candidate's full professional story. Whether you're exploring a career change or taking your next step, we look forward to reviewing your application. If this just isn't the right role or time - sign up for job alerts (**************************************** !
**Where we work**
PagerDuty operates a hybrid work model with offices (**************************************** in 8 major cities: Atlanta, Lisbon, London, San Francisco, Santiago, Sydney, Tokyo, and Toronto. While we offer flexibility within our established locations, we **cannot** employ candidates residing in:
**Location restrictions:**
**Australia:** Northern Territory, Queensland, South Australia, Tasmania, Western Australia
**Canada:** Alberta, Manitoba, Newfoundland, Northwest Territories, Nunavut, PEI, Quebec, Saskatchewan, Yukon
**United States:** Alaska, Hawaii, Iowa, Louisiana, Mississippi, Nebraska, New Mexico, Oklahoma, Rhode Island, South Dakota, West Virginia, Wyoming
_Candidates must reside in an eligible location, which vary by role._
**How we work**
Our values (************************************** guide how we support customers, collaborate with colleagues, develop products, and foster a culture of belonging. They define not just our actions, but what it means to be Dutonian.
People Leaders at PagerDuty are responsible for creating high performance environments that drive accountability. PagerDuty has four key dimensions that define our Leadership Impact: Lead Self, Lead the Team, Lead the Business, and Lead the Future. Each dimension has three associated competencies to give leaders a shared language for guiding their development, career, promotion, and succession planning discussions. Our Manager Expectations serve as a practical guide for managers to understand their responsibilities, prioritize their efforts, and drive engagement and performance.
**What we offer**
As a global organization, our total rewards approach is competitive with industry standards and aligned with local laws and regulations. Learn more, including country-specific offerings, on our benefits site (********************************************** .
**Your package may include:**
+ Competitive salary
+ Comprehensive benefits package
+ Flexible work arrangements
+ Company equity*
+ ESPP (Employee Stock Purchase Program)*
+ Retirement or pension plan*
+ Generous paid vacation time
+ Paid holidays and sick leave
+ Dutonian Wellness Days & HibernationDuty - companywide paid days off in addition to PTO
+ Paid parental leave: 22 weeks for pregnant parent, 12 weeks for non-pregnant parent (some countries have longer leave standards and we comply with local laws)*
+ Paid volunteer time off: 20 hours per year
+ Company-wide hack weeks
+ Mental wellness programs
*Eligibility may vary by role, region, and tenure
**About PagerDuty**
PagerDuty, Inc. (NYSE:PD) is a global leader in digital operations management. The PagerDuty Operations Cloud is an AI-powered platform that empowers business resilience and drives operational efficiency for enterprises. With a generative AI assistant at its core, PagerDuty empowers teams to detect and resolve issues in real time, orchestrate complex workflows, and drive continuous improvement across their digital operations. Trusted by nearly half of both the Fortune 500 and the Forbes AI 50, as well as approximately two-thirds of the Fortune 100, PagerDuty is essential for delivering always-on digital experiences to modern businesses
PagerDuty is Great Place to Work-certified, a Fortune Best Workplace for Millennials, a Fortune Best Medium Workplace, a Fortune Best Workplace in Technology, and a top rated product on TrustRadius and G2.
Go behind-the-scenes on our careers site (*********************************** and @pagerduty on Instagram.
**Additional Information**
PagerDuty is an equal opportunity employer. PagerDuty does not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, parental status, veteran status, or disability status. Your privacy is important to us. By submitting an application, you confirm that you have read and understand PagerDuty's Privacy Policy (****************************************** .
PagerDuty is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application process. Should you require accommodation, please email accommodation@pagerduty.com and we will work with you to meet your accessibility needs.
PagerDuty uses the E-Verify employment verification program.
Senior Director, Facilities & Engineering
Director of strategy job in Durham, NC
The Senior Director, Facilities and Engineering is responsible for the building and equipment and system performance of a cGMP manufacturing facility. The Senior Director leads, manages, and coaches engineering, validation, maintenance, and capital project staff to ensure equipment and systems are designed, installed, and consistently perform as intended when needed. S/He develops an engaged, high performing team that demonstrates KBI core values with a culture of safety and quality.
The Senior Director develops strategies, processes, systems, procedures, and metrics to achieve a high level of facility and equipment availability, reliability, and performance. S/He monitors equipment work orders, change controls, qualification status, and readiness. Manages facility and engineering processes associated with new product introductions. The Senior Director is responsible for developing and implementing strategies, methods, and procedures for new and existing facilities and equipment.
The Senior Director works to ensure alignment and coordinates with other site functions such as Finance, Manufacturing, MS&T, QC Analytical/Laboratories, and Quality Assurance. Leads efforts of the organization across functional boundaries and works with peers across a matrixed organization. Represents the functional area to clients, auditors, and inspectors.
Oversees engineering support for multiple systems, processes, or areas. Develops subject matter experts in several areas. Applies advanced approaches to develop and implement strategies, technologies, or other major improvements. Directs, reviews, and approves engineering documents. Support monthly reports covering overall status, key issues, and performance KPI's.
Responsible for directing, developing, and implementing the necessary controls and systems for the Plant Engineering, Facilities, Maintenance and Calibration, Validation and CAPEX project functions.
Staff will provide technical decision-making regarding project implementation strategies as well as requirements for projects and change controls. This includes drafting and owning risk assessments, plans, and procedures. Staff will be responsible for reviewing and approving team member's work.
Staff member will be expected to provide exceptional customer service to internal and external clients. Staff must have the ability to interface effectively with personnel across quality, validation, maintenance, and other technical disciplines.
Responsibilities
Directs engineering, validation, capital project, and maintenance activities for the site. Oversee corrective and preventative maintenance and repair of facilities, utilities, and equipment. Direct implementation of improvements to reduce failures and errors. Oversees multiple capital projects and operational improvement projects, DEVs, CAPAs, and/or Change Controls while ensuring their success in meeting their respective objectives. Represent the Facilities & Engineering activities during client audits and regulatory inspections.
Ensures engineering, maintenance, and calibration procedures and systems are in a state of compliance and control. Establish and maintain a system of metrics and reporting to evaluate the effectiveness of facility and maintenance activities.
Responsible for the employment, employee motivation, counseling, discipline, and changes in status of employees supervised. Responsible for team building, organizational development, training.
Development, strategy, planning, and execution related to drive improvements and achievement of objectives and goals.
Resource planning and performance management including coaching, mentoring, development, and discipline.
Minimum Requirements
The requirements listed below are intended to show the base level minimum competencies/skills required to achieve each job level within the job function. These competencies/skills are only part of the evaluation process for advancement within the job function but server as a road map for potential advancement. Other factors in the evaluation process for advancement include things such as impact, leadership qualities, experience, education, business needs, etc. These factors are documented through the evaluation process and 1:1 with manager.
Knowledge, Skills, Abilities
Minimum of Bachelor's degree in an engineering discipline (mechanical, electrical, chemical, biomechanical). Minimum 15 years engineering experience with minimum of 10 years in biotech industry and 5 years management experience
Established expertise and knowledge of biopharmaceutical manufacturing, good engineering practices, and equipment design and qualification. Strong technical writing and communication skills.
Ability to use negotiation skills drive to resolution on critical issues. Ability to summarize complex issues and present to executive management.
A broad understanding of applicable codes, and in depth working knowledge of cGMP requirements and regulations.
Demonstrated track record in the following key areas:
Strong orientation for quality and customer service
High level of integrity and personal responsibility
Communication skills within all levels of an organization
Ability to align growth requirements and profit objectives
Risk assessment and risk management
Project management including project delivery under aggressive timelines
Staff development and coaching
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Auto-ApplyAssociate Director for Digital Strategy
Director of strategy job in Raleigh, NC
Join the NC State University Libraries and help us create adventurous, innovative services and library spaces that delight students, faculty, and researchers. The award-winning James B. Hunt Jr. Library on NC State's Centennial Campus, offers access to advanced technologies that are enabling revolutionary ways to see and use information. Capturing NC State's spirit of innovation in education and research, the Hunt Library is recognized as one of the world's most creative and inspirational learning and collaborative spaces and a model for "the library of the future." The D. H. Hill Jr. Library, serving the main campus, combines the best of tradition and innovation, housing special collections and a beautiful gallery alongside vibrant, experiential spaces for making, digital media creation, data analysis and visualization, and collaboration. Three branch libraries focus on design, natural resources, and veterinary medicine.
Wolfpack Perks and Benefits
As a Pack member, you belong here, and can enjoy exclusive perks designed to enhance your personal and professional well-being. As you consider this opportunity, we encourage you to review our Employee Value Proposition and learn more about what makes NC State the best place to learn and work for everyone.
What we offer:
* Medical, Dental, and Vision
* Flexible Spending Account
* Retirement Programs
* Disability Plans
* Life Insurance
* Accident Plan
* Paid Time Off and Other Leave Programs
* 12 Holidays Each Year
* Tuition and Academic Assistance
* And so much more!
Attain Work-life balance with our Childcare benefits, Wellness & Recreation Membership, and Wellness Programs that aim to build a thriving wolfpack community.
Disclaimer: Perks and Benefit eligibility is based on Part-Time or Full-Time Employment status. Eligibility and Employer Sponsored Plans can be found within each of the links offered.
Essential Job Duties
The NC State University Libraries invites applications and nominations for the position of Associate Director for Digital Strategy. The Digital Strategy division includes four departments: Data Science Services (DSS), Digital Library Initiatives (DLI), Information Technology (IT), and the Research Facilitation Service (RFS). Division staff play essential roles in providing technology-rich research services and environments that enable students, faculty, staff, and researchers to discover, create, and share new knowledge and develop multidisciplinary solutions to current and emerging challenges.
Data Science Services (7 FTE) provides consultations, instruction, computing resources, and software support for a wide range of data lifecycle activities, including data collection, discovery, evaluation, management, modeling, analysis, visualization, and metadata creation. The department manages the Hunt Library Dataspace and the Hill Library Data Experience Lab, and collaborates closely with the university's Data Science and AI Academy.
Digital Library Initiatives (12 FTE) applies systems analysis, design, service development, and software development skills to create and enhance a broad range of digital library products and services. DLI develops and supports the core systems that provide access to the Libraries' print and electronic resources, including SirsiDynix Symphony (migrating to Ex Libris' Alma in 2026), ILLiad, EZproxy, and the CORAL electronic resources management system, plus additional open source and locally developed applications.
Information Technology (18 FTE) defines technology requirements for library initiatives and develops infrastructure to support the Libraries' ambitious technology agenda. Staff design and support the Libraries' technology-rich spaces; purchase, install, and maintain hardware and software to serve staff and patron computing needs; and investigate and recommend emerging systems and tools.
The Research Facilitation Service (3 Libraries FTE) is a joint endeavor of the Libraries, the Office of Information Technology, and the Office of Research Innovation. It provides a single point of contact for research computing and data management questions and consultation, strengthens communication among university service providers, and supports continuous assessment of researcher needs.
Responsibilities
The Associate Director for Digital Strategy provides vision and leadership for the division, helping to position the Libraries as a leader in advancing learning, research, and engagement at the university and to achieve the goals of the Libraries' Strategic Plan. They lead the division and collaborate with colleagues across the organization in developing, managing, and maintaining an innovative, flexible, and reliable digital environment that enables access to research collections; a robust data, computing, and software infrastructure; and user-centered services. The position works closely with university partners, including the Office of Information Technology, Distance Education and Learning Technology Applications (DELTA), Office of Research and Innovation, and the Data Science and AI Academy, and participates in the university's collaborative IT governance structure. The incumbent represents the Libraries in the Triangle Research Libraries Network, Coalition for Networked Information, Digital Library Federation, and other regional and national forums and initiatives. As a member of the Libraries' senior administrative team, they participate in library planning, policy development, resource allocation, and personnel management. Librarians are expected to be active professionally and to contribute to developments in the field. The position reports to the Senior Vice Provost & Director of Libraries.
Other Responsibilities
Other duties as assigned.
Qualifications
Minimum Education and Experience
* ALA-accredited MLS, MIS, or equivalent advanced degree
Other Required Qualifications
* Significant and progressively responsible, relevant professional experience
* Significant management and leadership experience, including budget and personnel management
* Demonstrated knowledge of current technological trends and issues in higher education as they inform the library's role at a forward-looking research university
* Demonstrated knowledge and expertise in one or more areas of the division's portfolio
* Ability to develop and articulate a vision for the Libraries' digital strategy and services and to engage others in its success
* Demonstrated ability to make connections between library and university initiatives and to develop partnerships to advance them
* Ability to foster an environment of belonging and well-being
* Ability to communicate clearly and knowledgeably
* Demonstrated record of ongoing professional development
Preferred Qualifications
N/A
Required License(s) or Certification(s)
N/A
Valid NC Driver's License required No Commercial Driver's License required No
Director, Consumer Insights & UXR
Director of strategy job in Cary, NC
WHAT MAKES US EPIC? At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually stunning interactive experiences, we're always innovating.
Being Epic means being a part of a team that continually strives to do right by our community and users. We're constantly innovating to raise the bar of engine and game development.
UX RESEARCH
What We Do
Our team of UX researchers provide rigorous research support and insights for all of our games and products. Our goal is to be the voice of our players and users, and help the designer-intended experience for them be realized.
What You'll Do
As the Director, Consumer & UXR, you will be responsible for leading, growing, and championing a team made up of three main teams, each with their own manager: the User Experience Research Team, the User Experience Data Research Team, and the User Experience Playtest Research Team. Via your experience and deep methodological understanding you will lead these teams in producing the highest quality and actionable research possible.
In this role, you will
* Leading the User Experience Research team in creating accurate, legally compliant, quick, and actionable research insights for all products at Epic
* Guiding the methodology and processes of the User Experience Research team, including growing the capabilities and skills of the team, while also reviewing and being deeply aware of the Insights coming from your team. You should be the methodology expert for user/player research at the company as well as knowing about past, current, and future research and insights
* Being involved in and improving peer review and research design, analysis, and visualization across the team
* Representing and championing the data of your team and User Research processes and value across Epic and at the highest levels of the company
* Maintaining, building, and growing relationships within the company with partners and senior leaders
* Working closely with other leaders in Insights and Product management to build a complete picture of players and users
* Legal compliance tasks around data collection and storage that you can also communicate within the team
What we're looking for
* 8+ years of leadership experience
* 9+ years of User Experience Research experience in the games industry
* You are a research methodology expert (UX Research, survey design, and analysis) and live and breathe how to design research to get high quality accurate and actionable insights quickly. You are a scientist that cares deeply that research is carried out correctly
* Excellent communication and interpersonal skills. You can deliver information about where things are not working in a way that is not only direct, understood, and actionable, but is also empathic and understands the challenges that designs and developers are facing. Your team's Insights must also be heard at and understood at the highest levels of the company.
* A passion for games and understanding the experiences of game players. You must deeply understand the gaming space
* Experience working with the legal requirements around personal information and research
* Experience in writing and reviewing detailed reports and presenting data findings/analysis at all levels
* SQL and/or Tableau experience
* Market Research/Consumer Insights Experience
* Unreal Engine Experience
EPIC JOB + EPIC BENEFITS = EPIC LIFE
Our intent is to cover all things that are medically necessary and improve the quality of life. We pay 100% of the premiums for both you and your dependents. Our coverage includes Medical, Dental, a Vision HRA, Long Term Disability, Life Insurance & a 401k with competitive match. We also offer a robust mental well-being program through Modern Health, which provides free therapy and coaching for employees & dependents. Throughout the year we celebrate our employees with events and company-wide paid breaks. We offer unlimited PTO and sick time and recognize individuals for 7 years of employment with a paid sabbatical.
ABOUT US
Epic Games spans across 25 countries with 46 studios and 4,500+ employees globally. For over 25 years, we've been making award-winning games and engine technology that empowers others to make visually stunning games and 3D content that bring environments to life like never before. Epic's award-winning Unreal Engine technology not only provides game developers the ability to build high-fidelity, interactive experiences for PC, console, mobile, and VR, it is also a tool being embraced by content creators across a variety of industries such as media and entertainment, automotive, and architectural design. As we continue to build our Engine technology and develop remarkable games, we strive to build teams of world-class talent.
Like what you hear? Come be a part of something Epic!
Epic Games deeply values diverse teams and an inclusive work culture, and we are proud to be an Equal Opportunity employer. Learn more about our Equal Employment Opportunity (EEO) Policy here.
Note to Recruitment Agencies: Epic does not accept any unsolicited resumes or approaches from any unauthorized third party (including recruitment or placement agencies) (i.e., a third party with whom we do not have a negotiated and validly executed agreement). We will not pay any fees to any unauthorized third party. Further details on these matters can be found here.
Auto-ApplyDirector, Market Access Strategy, Access Optimization Lead - Specialty
Director of strategy job in Durham, NC
Site Name: USA - Pennsylvania - Philadelphia, Durham Blackwell Street Reporting to the Senior Director Market Access Strategy, Access Optimization - Specialty, the Director, Market Access Strategy, Access Optimization Lead - Specialty is responsible for creating and owning the holistic Market Access (MA) strategies and tactics for all payers, institutional, pricing/contracting, patient services and trade/channel customer segments (e.g. Commercial, Medicaid, Medicare, hospital, IDN/health systems, wholesalers, specialty pharmacies/distributors, etc.).
This Director is responsible for creating the market access strategy to support access across the access landscape, identifying customer & competitive insights, and evolving the value proposition and supporting deliverables accordingly to ensure optimal impact and utility. The Director will own the development of near-term, mid-term and long-term Market Access strategies in collaboration with GSK stakeholders including pricing/contracting, channel strategy, payer strategy, patient services, MA field-based teams, MA Marketing, MA strategic analytics, brand marketing teams, brand analytics, pipeline strategy, and customer-facing teams. The Director will be responsible for delivering the strategic tradeoffs of access investments across access functions in support of brand objectives.
This role will be responsible for supporting established and soon to be launched specialty products in GSK's Respiratory hepatology portfolio and will require experience with both payers and health systems.
This Director will sit on the Integrated Brand Commercialization Team (IBCT) for their asset(s) and directly influence the market access strategy and execution of the access/launch plan, playing a part in its' performance management.
This role will provide YOU with the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
* Create and own near/mid/long term access strategies for brand and therapeutic areas at channel level focused on optimizing access through strategic tradeoffs of resources and activities inclusive of forecast and Gross-to-Net tradeoffs across pricing, payer, provider, patient access, pharmacy and distribution needs.
* Evolve market access strategies over time through monitoring of access environment and competitive landscape and coordinate cross functionally to ensure alignment.
* Drive cross functional access strategy synergies with broader brand strategy at IBCT level inclusive of customer perspective and evolving access and environmental considerations.
* Deliver key access insights to brand leadership cultivated through close collaboration of field facing and in house market access colleagues and reciprocate brand insights to market access partners.
* Own market access component of brand level strategic plans and ops plan, ensuring alignment to brand objectives as well as near/mid/long term market access objectives.
* Lead Market Access focused collaborative efforts with brand, global, finance, and others in support of best-in-class launch strategy development for new to market brands and new indications.
* Partner closely with Value Evidence & Outcomes (aka HEOR) and Access Optimization Marketing, Analytics & Strategy team to ensure value prop and customer materials are in alignment to brand and market access strategies and developed in a timely matter to support organizational needs and potential launches.
* Deliver critical brand and Access Optimization needs to business partners in a timely fashion to ensure value prop, customer material development, and field priorities are in line with brand objectives.
* Develop access journey for brands, highlighting critical access components including pricing/contracting, channel strategy, payer strategy, patient services, enterprise strategy, etc.
* Create and manage insights-based tactical plans across key customer segments to prioritize efforts that deliver business impact and utilize resources efficiently.
* Partner in the development of the end-to-end customer facing and multichannel marketing promotional interventions for payers, channel partners, customer-facing teams (includes account manager promotional materials, value propositions, e-tactics, leave-behinds, etc.) - from opportunity identification to training and implementation guides.
* Collaborate in the development of access and customer materials for field use including those related to patient services (HUB), Payers, SGPOs, Population Based Decision Making, etc.
* Partner with brand team and matrix stakeholders to identify brand-specific opportunities and ensure a clear understanding of the competitive access environment.
* Support insights development including conducting primary market research to support the market access strategy and tactical planning.
* Monitor & synthesize syndicated market research and external issues impacting pharmaceutical delivery and reimbursement including industry trends, public policy, and competitive landscape.
* Support the evolution of the payer value proposition across payer segments including short-term delivery of in-market payer promotional tactics and long-term influencing of evidence generation planning.
* Monitor the external environment and ensure timely stakeholder (both home office and customer-facing) communications that clearly inform and offer strategic guidance where appropriate in response to competitive market events and changes.
* Partner with cross-functional Business Unit teams to understand key brand objectives and to ensure market access strategy is properly considered and implemented.
Why you?
Basic Qualifications:
We are looking for professionals with the required skills to achieve our goals:
* Bachelor's degree
* 3 years or more experience in market access or comparable biopharma area with a focus on payer strategy/marketing, account management or GPOs
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Master's degree
* Demonstrated experience in US healthcare strategic and analytic mindset/ market dynamics / payer landscape / account management.
* Demonstrated experience in developing Payer and segment specific marketing insights and incorporating the payer into the brand/strategic planning process.
* Demonstrated experience in specialty, oncology, rare disease, and / or cell & gene therapy product experience.
* Previous branded product launch experience
* Previous experience in the access and reimbursement of specialty or oncology products, including hub support, pharmacy benefit model, buy and bill model, specialty pharmacy, and working with account management, patient support / field reimbursement teams.
* Experience managing tradeoffs between business initiatives within a finite budget and recommending courses of action to leadership.
* Ability to combine data analysis with qualitative insights to identify and explain market access, brand and above-brand drivers of business performance.
* Excellent communication (written, verbal and presentation), interpersonal influencing and prioritization skills required with proven ability to influence across matrixed organizations including influencing without authority.
* Proven ability to operate independently and handle multiple projects with a high degree of initiative including project planning and prioritization of competing demands.
* Basic understanding of corporate finance fundamentals (gross & net sales, P&L inputs, gross margin, COGs, working capital, etc.)
* Experience developing and managing promotional budgets.
* Experience managing third-party vendors.
* Proven ability to develop and maintain trusted relationships with internal partners and effectively work well in teams.
#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ************************ where you can also request a call.
Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive
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Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************
Auto-ApplyDirector, Regulatory Affairs - Clinical Strategy
Director of strategy job in Raleigh, NC
Job Description
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As 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. For more information, visit ****************
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief 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. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities. The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.
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
Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports
CORE Responsibilities
Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2) NDA submissions
Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths
Qualifications and Education Requirements
10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
Bachelor's degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)
#LI-Hybrid
Physical & Mental Requirements:
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to sit for long periods of time
While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
May occasionally climb stairs and/or ride elevators
The employee must occasionally lift and/or move up to 25 pounds
Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
Other miscellaneous job duties as required
Benefits We Offer:
Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
Fuel Your Success: *
Sales Only*
- We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *
Excludes Sales, Manufacturing, and some Operations positions*
Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.
Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
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