Director, Pharmaceutical Global Advertising & Promotion
King of Prussia, PA jobs
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Director, Global Advertising and Promotion? The job is in our King of Prussia, PA office or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will report to the Executive Director, Head, Global Labeling & Labeling Data Strategy.
The Director, Global Advertising and Promotion is responsible for developing and overseeing the regulatory strategy and compliance of promotional and non-promotional with a global focus. This role ensures that all advertising, promotional, and external communications activities for markets ex-US comply with applicable regulations, guidelines, and company policies. The incumbent will provide leadership across regions (e.g., EU, APAC, LATAM) and collaborate with cross-functional partners including Marketing, Legal, Medical Affairs, and Commercial to drive compliant and innovative messaging that satisfies regulatory requirements while meeting strategic corporate and business objectives.
Main Responsibilities & Accountabilities
•Strategic Leadership:
Provide global oversight, leadership and direction to develop and execute global regulatory ad/promo strategies to support product commercialization, lifecycle management, and expansion into new markets.•Regulatory Review & Compliance:
Participate in the review and approval process for promotional and non-promotional materials (e.g., websites, social media, HCP/patient brochures, press releases) for consistency with local and international regulatory requirements (e.g., EMA, PMDA).•Regulatory Authority Interaction:
Serve as the primary point of contact with regulatory bodies on advertising and promotion matters, including submission of materials to Health Authorities, responding to inquiries, and managing enforcement risk.•Cross-functional Collaboration:
Partner with Legal, Compliance, Medical, and Commercial teams to ensure accurate and balanced content in alignment with product labeling and company strategy.•Policy and SOP Development:
Lead the development and implementation of global policies, standard operating procedures (SOPs), and training programs for advertising and promotional review processes.•Team Leadership:
Build and manage a high-performing global ad/promo team of reviewers. Provide mentorship, professional development, and performance management.•Risk Assessment:
Identify and mitigate regulatory risks in promotional materials and campaigns. Provide guidance during concept development and campaign planning phases.•Innovation Enablement:
Support the integration of digital and emerging media in advertising strategies while maintaining compliance.
Qualifications & Experience Requirements
Bachelor's degree required.•8+ years of Regulatory Affairs experience, with at least 6+ years specifically in advertising and promotion within the pharmaceutical, biotechnology, or healthcare industry.•In-depth knowledge of global regulatory requirements and guidances (e.g., EMA, Health Canada).•Experience with regulatory submissions for promotional materials •Proven leadership skills in managing teams, projects, and cross-functional collaborations.#LI-HYBRIDOur Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
Senior Director, Client Service
New York, NY jobs
We go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. To start a career that is out of the ordinary, please apply...Job Details
Job Title: Senior Director, Client Service, Media
Job Location: Hybrid- Atlanta, Boston, Chicago, New York City, Norwalk
About the role
The Senior Director role is a strategic leadership position responsible for overseeing a portfolio of high-value accounts and guiding strategic account teams. This individual acts as a senior advisor to executive-level stakeholders, influencing investment decisions and driving multi-year growth plans. The role combines deep expertise in media research and analytics with executive engagement and commercial accountability.
Primary Responsibilities
Oversee a portfolio of high-value accounts; manage and lead small portfolio teams or strategic account teams to deliver exceptional client outcomes.
Serve as a senior advisor to executive-level stakeholders; influence strategic investment decisions through evidence-based insights.
Accountable for retention of portfolio and responsible for multi-year growth plans, cross-sell strategies, and achievement of significant revenue targets.
Lead executive-level research initiatives; synthesize primary, secondary, and advanced analytics into actionable narratives for senior decision-making.
Optimize resource allocation and deliver operational efficiency across portfolio teams; shape best practices for quality delivery at scale.
Represent Kantar in industry forums and enterprise-wide initiatives; champion innovation in media analytics and cross-platform measurement.
Develop and nurture high-performing teams by identifying, mentoring, and advancing top talent through a culture of continuous learning and collaboration.
Essential Knowledge & Experience
7+ years in media research, analytics, or consulting with proven success in executive-level engagement.
Expertise in digital ecosystems, cross-platform measurement methodologies, creative quality, and/or placement and audience insights.
Strong command of advanced research techniques, including attribution, ROI modeling, and audience segmentation.
Advanced ability to synthesize complex data into compelling narratives for executive audiences.
Proven ability to shape strategic investment decisions and drive commercial outcomes.
Track record of delivering multi-year growth plans and achieving significant revenue targets for an account portfolio.
Demonstrated success in managing senior client relationships and leading high-performing teams, including direct management of a team of 3 or more professionals.
Ability to navigate fast-paced agency or complex client environments, balancing strategic depth with delivery efficiency.
Bachelor's degree in market research/marketing or related social science and analytic subject areas. Masters preferred
Location
New York, World Trade CenterUnited States of America
Kantar Rewards Statement
At Kantar we have an integrated way of rewarding our people based around a simple, clear and consistent set of principles. Our approach helps to ensure we are market competitive and also to support a pay for performance culture, where your reward and career progression opportunities are linked to what you deliver.
We go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. Apply for a career that's out of the ordinary and join us.
We want to create an equality of opportunity in a fair and supportive working environment where people feel included, accepted and are allowed to flourish in a space where their mental health and well being is taken into consideration.
We want to create a more diverse community to expand our talent pool, be locally representative, drive diversity of thinking and better commercial outcomes.
Kantar is the world's leading data, insights and consulting company. We understand more about how people think, feel, shop, share, vote and view than anyone else. Combining our expertise in human understanding with advanced technologies, Kantar's 30,000 people help the world's leading organisations succeed and grow.
Director/Senior Director, Analytical Development
New York, NY jobs
Head of Analytical Development: NYC
We are seeking a Director or Senior Director of Analytical Development to lead and expand the analytical development function. This individual will play a pivotal role in supporting late-stage programs, ensuring robust analytical strategies for drug substance and drug product, and driving method development, validation, and transfer activities.
This is a hands-on leadership role for someone who thrives in a dynamic environment, enjoys rolling up their sleeves, and is committed to building best-in-class analytical capabilities. The ideal candidate will be comfortable commuting to the New York site four days per week and collaborating cross-functionally with CMC, Quality, and external partners.
Key Responsibilities
Lead the Analytical Development team responsible for method development, qualification, validation, and transfer for drug substance and drug product.
Develop and implement analytical strategies to support late-stage development, scale-up, and commercialization.
Oversee characterization studies, stability programs, and specification setting in alignment with regulatory requirements.
Partner closely with Process Development, Quality, and Regulatory teams to ensure seamless integration of analytical deliverables.
Manage relationships with CDMOs and external testing labs, ensuring timelines and quality standards are met.
Provide technical leadership and mentorship to a growing team, fostering a culture of scientific excellence and accountability.
Contribute to regulatory submissions (IND, NDA) and represent Analytical Development in health authority interactions as needed.
Qualifications
Ph.D. or M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
10+ years of experience in analytical development within the biotech or pharmaceutical industry, with a strong focus on small molecule late-stage development and commercialization.
Proven track record of leadership in method development, validation, and transfer for complex modalities (biologics experience strongly preferred).
Deep understanding of ICH guidelines, regulatory expectations, and CMC requirements for global filings.
Excellent communication and collaboration skills; ability to work effectively in a fast-paced, matrixed environment.
Willingness and ability to be onsite in New York 4 days per week.
Why Join?
Opportunity to shape analytical strategy for a late-stage pipeline with high-impact programs.
Work in a well-funded biotech with strong pharma partnerships and a clear path to commercialization.
Collaborative, science-driven culture where your contributions make a tangible difference.
Director, Global Market Access
Boston, MA jobs
Greater Boston or Greater Philadelphia (on-site 3 days a week)
A Specialty Pharmaceutical company in a hyper-growth mode with a recent, successful US launch is seeking an experienced Global Market Access individual to join their team in preparation for their global launch. This position will be crucial in driving both the strategic and operational aspects of market access strategy, pricing, payer acceptance, and strategic payer market research to drive patient outcomes on an international scale.
Responsibilities:
Develop and execute global market access and payer strategies by designing integrated approaches, aligning with lifecycle management, and ensuring pricing, access, and funding objectives are met across regions.
Lead comprehensive market/payer research including analog assessments, health technology appraisal outcomes, and burden-of-disease analysis to inform pricing estimates, evidence packages, and target product profiles.
Support strategic decision-making for portfolio and pipeline by providing insights on market access potential, shaping value propositions, and proactively mitigating risks from evolving policy reforms and competitive landscapes.
Drive cross-functional collaboration with multiple teams, including HEOR, Marketing, Medical Affairs, Public Affairs, and regional teams to ensure robust value propositions and alignment with global brand strategies.
Enable global implementation and capability building through market access strategy training, ensuring consistency and readiness across all teams.
Qualifications:
12+ years relevant experience in the pharmaceutical industry, and requiring 6+ years in Global Market Access, preferably with direct exposure to European Markets.
Proven track record in shaping strategies for patient access, pricing, and reimbursement while anticipating industry trends and market dynamic.
Strong analytical and financial skills combined with the ability to communicate effectively through presentations and stakeholder engagement at senior levels.
Looking for someone with an entrepreneurial mindset who is ready to drive impact and accomplish objectives swiftly and urgently.
Must be able to travel up to 30%
If you are ready to take the next step with a fast-paced, growing pharma with an exciting product and pipeline, this could be a great fit. Unlock your next career achievement by applying here, and a dedicated recruiter will be in touch!
Vice President of Site Operations
Cedar Rapids, IA jobs
JRS Pharma LP is seeking an experienced Vice President of Site Operations to lead our Cedar Rapids, Iowa manufacturing facility-one of the core production sites within our U.S. footprint. This senior leadership role is critical to driving operational excellence, ensuring consistent product quality, strengthening site performance, and aligning day-to-day operations with our long-term business strategy.
The VP of Site Operations will oversee all facets of site execution, including manufacturing, maintenance, engineering, quality partnership, supply chain coordination, safety culture, and talent development. This role works cross-functionally with corporate leadership in Patterson, NY and Holzmühle, Germany, ensuring the Cedar Rapids site operates with the highest standards of efficiency, cGMP compliance, and continuous improvement.
As part of a collaborative, fast-paced, and solutions-driven leadership team, you will shape the operational strategy, steward organizational culture, and ensure the site is positioned for sustainable growth and customer value. At JRS Pharma, you will have the opportunity to make a significant impact on operational performance, global alignment, and the future of our North American manufacturing network. If you are results-oriented, energized by developing people and processes, and motivated to lead a high-performing manufacturing site, we want you on our team.
JRS Pharma is a critical manufacturer of excipient products to the branded and generic drug, over-the-counter, and nutritional supplement industries. We offer a complete portfolio of formulation solutions for the global life science industry supported by Quality manufacturing and strong technical support. At JRS Pharma, we are dedicated to delivering sustainable and reliable products that meet the highest standards of performance and consistency. We prioritize employee safety and professional development, fostering a family culture of care and responsibility. Through strong corporate governance and a commitment to long-term security and stability, we build lasting partnership with our employees, customers, suppliers, and communities.
JRS Pharma is division of the JRS Group. Founded in 1878, the JRS Group has over 140 years of history and services numerous industries across all major markets through extensive manufacturing operations, sales offices and R&D centers.
Position Summary:
The Vice President of Site Operations is responsible for driving operational excellence, meeting budgeted manufacturing output, overall site budget and managing supporting departments for the Cedar Rapids production facilities. The departments include the operational plants, maintenance, integration, warehouse, administration and safety. These responsibilities will be carried out in a manner that maintains the standards of the plants in accordance with Good Manufacturing Practices in a safe, efficient manner to produce Quality products.
Essential Duties and Responsibilities:
Direct and manage overall site operations including safety, environmental, production, maintenance, warehousing, administration, corporate support, and customer relations.
Guarantee on-time supply of “right the first time” Quality product.
Develop and implement continuous process improvement to reduce cost, downtime, and inefficiencies across departments at the site.
Coordinate site activities through planning with Headquarters, NY business offices, and plant departmental managers to ensure all manufacturing objectives are accomplished in a timely and cost-effective manner.
Partner closely with Finance to ensure site operations meet budgetary goals, cost-control targets, and capital project requirements.
Ensure strong collaboration with HR on workforce planning, organizational development, employee engagement, and succession planning.
Provide leadership and direction to develop personnel and to accomplish company goals and objectives.
Actively participate in proactive Human Resource resolutions as well as hiring, disciplinary actions, terminations, and transfers of personnel.
Provide leadership support during customer audits and ensure timely corrective and preventative action follow-up.
Partner with Quality and Technical Operations to maintain and advance compliance with FDA, GMP, and other regulatory guidelines.
Assure compliance with OSHA, environmental, and safety requirements.
Maintain consistent collaboration and communication with Headquarters to align employee HR strategy. financial budget, sales needs, customer service, and global supply-chain priorities.
Represent the site in corporate and global forums, ensuring transparency and alignment with global leadership priorities.
Champion a culture of accountability, collaboration, and innovation across all levels of the organization.
Execute other responsibilities and projects as required.
Education and/or Work Experience Requirements:
BS or Masters in Science, Engineering or related subject
Working knowledge of FDA regulations, GMP and ISO 9000 guidelines
8-15 years' experience in leadership of manufacturing operations
Experience with budgets and capital projects required
Extensive experience in working with stakeholders to create hiring strategies to develop quality teams.
Experience in Managing Manufacturing Operations
Must be knowledgeable about industry trends, best practices, and change management
Experience in operations/maintenance involving fine chemicals or pharmaceutical manufacturing environment
Physical Requirements:
Exhibit leadership and strong interpersonal skills; be capable of assuming responsibility for and managing diverse tasks.
Ability to travel as needed
Director of Marketing & Customer Analytics
Dallas, TX jobs
Reports to: Director of Planning & Analysis
Shop Avara is seeking a strategic and hands on-leader as our Director of Marketing and Customer Analytics to lead data-driven insights that fuel growth of our brand. This role will be the go-to partner for the Marketing and E-commerce teams - helping the organization deeply understand customer behavior, campaign performance, attribution, and lifetime value. You will blend analytical rigor with business understanding, turning complex data into actionable findings that can allow the marketing team to optimize acquisition, retention, and engagement. The ideal candidate thrives in a fast paced, entrepreneurial environment and is passionate about using data to unlock profitable customer growth and brand potential.
Key Responsibilities
Customer & Audience Insights
Lead deep understanding of who our current customer is - their motivations, preferences, purchase drivers, and behavioral patterns.
Own customer segmentation and profiling to identify high-value audiences and behavioral patterns.
Analyze customer acquisition, retention, repeat purchase, and churn dynamics across channels.
Build and maintain dashboards tracking customer KPIs (LTV, CAC, retention rate, frequency, AOV).
Partner with the Marketing and E-commerce teams to inform targeting, personalization, and lifecycle strategies.
Marketing Performance Analysis
Lead measurement and reporting of marketing campaign performance across paid, owned, and earned channels.
Build and refine marketing attribution models to assess ROI and inform budget allocation.
Identify drivers of traffic, conversion, and engagement to optimize channel strategy and creative direction.
E-commerce & Digital Analytics
Collaborate with the E-commerce team to monitor site performance, conversion funnel, and customer journey metrics.
Conduct deep-dive analyses on site behavior to identify conversion opportunities and UX improvements.
Partner on A/B testing strategy and post-campaign performance evaluations.
Data Infrastructure & Tooling
Work with Data Engineering partners to ensure data pipelines, tagging, and integrations are optimized for marketing measurement.
Define data requirements and metrics for new marketing channels, campaigns, and customer programs.
Implement and manage analytics tools and visualization platforms (e.g., GA4, Looker, Amplitude, or similar).
Cross-Functional Partnership
Work closely with FP&A to align marketing performance insights with financial outcomes (CAC, payback, contribution margin).
Collaborate cross functionally on insights that inform product development and brand storytelling.
Present findings and strategic recommendations to cross functional partners and leadership in a clear, compelling, and actionable way.
Associate Director Regulatory Strategy
Boston, MA jobs
Title: Associate Director of Regulatory Strategy
A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development.
Key Responsibilities
Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning.
Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters.
Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor.
Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements.
Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities.
Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation.
Qualifications
Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development.
Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies).
Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).
Familiarity with 505(b)(2) development strategies or innovative delivery platforms.
Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas.
Proven track record of successful interactions with the FDA and/or global regulatory agencies.
Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.
Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.
Associate Director, HCP Marketing, Rare Disease
Cambridge, MA jobs
Ipsen's Rare Disease franchise has been expanding through both organic growth and acquisitions. From a marketing standpoint, there is a critical need for excellence in strategic planning and in execution to clearly define how we will best drive education of appropriate healthcare providers, deliver successful launches, and win in highly competitive spaces.
The Associate Director, HCP Marketing, PBC is a key role on the Rare Disease Commercial Team and will report to the Iqirvo Brand Lead. The AD will support US marketing initiatives and key promotional activities to help the Rare team achieve near-term revenue goals and support the ongoing successful launch of Iqirvo. Responsibilities will encompass traditional HCP marketing including brand planning, development of materials and messages for multichannel engagement focused on congresses, advisory boards, peer to peer educational programs and KOL engagements. The role will include execution of both personal and non-personal promotional tactics.
The AD will collaborate with the Thought Leader Engagement Team, Field leadership, Sales training, Medical Affairs, Legal & Business Ethics to execute tactics focused on HCP Marketing.
Main Responsibilities & Job Expectations:
Core Marketing Activities
Lead key initiatives to implement tactical HCP Marketing plan
Development & execution congress marketing plans & materials
Speaker bureau content strategy, training, execution & ongoing management
Advisory board planning and execution
Amplify peer to peer messaging through multichannel engagement tactics
Develop and monitor KPIs for brand tactical plan and communicate performance vs leading and lagging indicator to Rare disease leadership
Contribute to Brand Planning and Tactical Plan development for Iqirvo
Ensure compliant execution of all promotional activities
Collaborate with:
Rare disease field leadership to provide support with sales force execution and gain feedback and insights to adjust and enhance materials / messages
Other brands teams within marketing to ensure cohesive delivery of portfolio strategy and unified external voice to customers
Thought Leader Liaison team & Sales Leadership on marketing material development, execution and performance
Promotional review committee to ensure compliant development of field resources in line with the strategy
Business ethics & legal team to ensure compliant development and implementation of projects
Cross Functional Collaboration & Stakeholder Management:
Incorporate insights from primary and secondary research into development of field promotional tactics
Share leadership responsibilities for regular cross-functional meetings including congress planning, bureau operations and brand team meetings
Work with advanced analytics to ensure appropriate understanding and implementation of brand strategy.
Knowledge, Abilities & Experience:
BA/BS is required: PharmD or MBA preferred
At least 10 years of experience in commercial pharmaceutical roles, with a minimum of 5 years in marketing
Successful launch experience in the rare of specialty categories, hepatology would be a strong plus
Excellent leadership, strategic planning, and project management skills
Proven track record of developing and executing successful healthcare professional (HCP)marketing strategies
Strong understanding of the rare disease landscape and patient needs
Excellent communication and interpersonal skills along with the ability to influence others
Ability to work with multiple internal cross-functional teams and successfully manage multiple projects simultaneously
Strong analytical skills with the ability to interpret data and make informed decisions
Knowledge of the AMA, ACCME, PhRMA and FDA regulations associated with promotion and industry-supported scientific education activities
Able to work from our Cambridge, MA HQ on a hybrid model including 2-3 days in office
Willingness to travel, including international, when needed
The annual base salary range for this position is $151,500 to $222,000
This job is eligible to participate in our short-term incentives program. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
Marketing Director
Raleigh, NC jobs
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.
Executive Director, Global Marketing Strategy and Operations
Philadelphia, PA jobs
Executive Director, Global Marketing Strategy & Operations
Location: Philadelphia, PA or Boston, MA (**Candidate must reside within 50 miles of either location with 3 days on-site required)
EPM Scientific is partnered with a rapidly growing, Commercial-Stage biopharma to hire an Executive Director of Global Marketing Strategy and Operations. This individual would play a key role in leading market strategy on a local and global scale as the company prepares for a global launch.
If you have an entrepreneurial spirit and thrive in a fast-paced environment with hyper-intense growth, this could be the opportunity for you!
Responsibilities:
Drive operational excellence and guide global brand and asset planning
Partner cross-functionally with commercial operations to develop streamlined strategy for new products
Execute early brand strategy to optimize go-to-market initiatives for both commercialized and pipeline products
Lead Promotional Review Committee (PRC)
Lead key U.S. marketing programs in partnership with HCP and DTC teams
Qualifications:
Bachelor's degree required, advanced degree (MBA, etc.) preferred
20+ years minimum experience required within marketing, commercial strategy, brand planning, marketing operations, new product planning, etc. within the pharmaceutical industry
Previous successful product launch experience required
Excellent team leadership experience and ability to lead by example
Skilled in resource planning, operational execution, and performance mgmt.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Director GHEOR
Conshohocken, PA jobs
Director of Global Health Economics and Outcomes Research
EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets.
Responsibilities:
Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management.
Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication.
Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement.
Provide strategic input into clinical trial design to inform payer and regulatory decisions.
Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs.
Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation.
Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives.
Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget.
Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives.
Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements.
Uphold the highest ethical standards in all external engagements.
Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed.
Requirements:
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Desired Skills and Experience
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Director GHEOR
Philadelphia, PA jobs
Director of Global Health Economics and Outcomes Research
EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets.
Responsibilities:
Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management.
Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication.
Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement.
Provide strategic input into clinical trial design to inform payer and regulatory decisions.
Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs.
Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation.
Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives.
Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget.
Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives.
Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements.
Uphold the highest ethical standards in all external engagements.
Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed.
Requirements:
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Desired Skills and Experience
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Leadership Management Program
Houston, TX jobs
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Senior Operations Management Trainee (Senior OMT)
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
Equal Employment Opportunity
Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth.
Our growth is your bright future.
Opportunities to grow as a leader are within your reach. With the incredible growth of 220+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference.
A typical day for you may include:
Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities.
Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees.
Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers.
Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management.
Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production.
Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend.
REQUIRED QUALIFICATIONS:
3-5 years of experience leading medium to large teams (20+ direct reports)
Up to 90-100% travel during the Trainee Program
Ability to walk and/or stand for the entire work shift
Willingness to travel and work at various BioLife locations across the country
Ability to work evenings, weekends, and holidays
Have a valid driver's license for the entire duration of the program
Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
Fine motor coordination, depth perception, and ability to hear equipment from a distance
Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
PREFERRED QUALIFICATIONS:
Associates or Bachelor's Degree
Experience working with SOPs, GDP, GMP, CLIA, and the FDA
Experience working in a highly regulated or high-volume retail environment
Excellent interpersonal, organizational, technical, and leadership skills
Equal Employment Opportunity
#LI-Remote
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
California - Virtual
U.S. Base Salary Range:
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsCalifornia - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
Yes
Associate Director- Field Access Management CRM Strategy and Operations Lead
Upper Gwynedd, PA jobs
Field Engagement Capabilities (FEC)
Associate Director (Band 400) - Field Access Management CRM Strategy and Operations Lead
The Field Access Management CRM Strategy and Operations Lead, reporting to the US Director of Field Engagement Capabilities, is responsible for defining and executing the strategic roadmap for the Field Access Management (FAM) CRM. This leader will ensure CRM capabilities are fully operational and aligned with priority business needs.
Serving as a cross-functional liaison, the FAM CRM Strategy and Operations Lead collaborate with technical teams, customer-facing operations, compliance, and external partners to drive seamless CRM enhancements, operational readiness, and digital enablement. The role combines strategic planning, agile execution, stakeholder engagement, and platform optimization to advance CRM effectiveness and customer engagement.
By leveraging a deep understanding of customer-facing functions, this leader partners with stakeholders across business and technical teams to evolve the strategic customer engagement model. As the CRM business owner, the Lead directly supports the transformation to a bi-directional engagement approach through CRM capabilities and processes.
Key Responsibilities
Define and communicate a clear strategic vision and roadmap for FAM CRM that aligns with enterprise objectives, enhances user experience, and leverages market best practices.
Serve as primary relationship lead for FAM CRM partner.
Maintain and execute the strategic FAM CRM roadmap, continually identifying opportunities for enhancement by following market trends and partnering with internal stakeholders and users to ensure business needs are met.
Ensure CRM capabilities function as intended and related business processes are executed to maximize capability realization.
Align processes with compliance requirements and prepare for core strategic platform upgrades from a business perspective.
Triage and resolve operational issues to meet business needs.
Manage CRM demand planning across all business units.
Develop and implement measurement plans to assess success.
Engage with legal, compliance, and other relevant bodies to ensure alignment on new customer interaction approaches.
Communicate with senior business leadership to align strategies, share progress, and mitigate risks.
Partner with technical and strategic stakeholders to implement CRM capabilities.
Qualifications
Education: BS/BA degree required.
Experience: Minimum of 5 years in Sales/Marketing Operations, IT, field sales, field access, or account management. Proven experience as a product owner, CRM manager, or in a similar enterprise-wide solution role.
Expertise: In-depth knowledge of Field Access CRM platforms, agile and scrum methodologies, program/project management, capability implementation, and business process design.
Skills: Strategic thinking, business acumen, and the ability to connect CRM functionality to broader business strategy and customer experience. Strong verbal and written communication skills, with the capacity to translate technical concepts for non-technical stakeholders. Demonstrated cross-functional collaboration, negotiation, and influence skills. Proficient in data analysis for CRM insights and data-driven decision-making.
Leadership Competencies
Strategic Planning: Guide team success using adaptable methods to build, motivate, and lead toward shared goals.
Business Savvy: Leverage organizational and industry insights to identify trends and evaluate business practices and changes.
Decision Making: Apply analytical skills to interpret information, evaluate alternatives, and make timely, effective decisions.
Execution Excellence: Focus on results and compliance, set ambitious goals, measure progress, and ensure accountability.
Change Catalyst: Lead and facilitate change, encourage adoption of improved approaches, and drive acceptance of change within the organization.
Required Skills:
Account Management, Account Management, Adaptability, Advertising Campaign Development, Agile Methodology, Business Acumen, Business Management, Business Processes, Business Process Management (BPM), Business Strategies, Business Thinking, Company Due Diligence, Creative Campaign Development, Customer Engagement, Decision Making, Digital Analytics, Marketing, Marketing Budget Management, Marketing Strategy Implementation, Market Research, Market Trends, People Leadership, Pharmaceutical Industry, Pricing Strategies, Principles of Marketing {+ 5 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$139,600.00 - $219,700.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at *******************************************************
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
12/10/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Auto-ApplySenior Director, Global Clinical Development - Nephrology & Immunology
Washington, DC jobs
**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.
**Culture**
As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.
Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.
**Pipeline**
Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.
You can learn more about Otsuka by clicking here! (*******************************************
****
**Position Summary**
Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings.
**Key Job Responsibilities**
+ Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
+ Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
+ Serve as the medical lead and subject matter expert for assigned indications.
+ Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes.
+ Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
+ Collaborate with regulatory affairs on interactions with global health authorities.
+ Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
+ Lead clinical discussions with KOLs and advisory boards.
+ Develop clinical documents including medical monitoring plans, asset development plans
+ Contribute to development of publication plans and review scientific manuscripts for publications.
+ Mentor and provide leadership to junior team members within the organization.
+ Support business development activities through medical due diligence and evaluation of external opportunities.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet company
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
+ Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
+ An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including:
+ Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
+ Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
+ Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
**Physical Demands and Work Environment**
+ Travel (~30-35%)
+ See document Physical Demands and Work Environment for further requirements.
**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 $245,454.00 - Maximum $381,110.00, 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.
Senior Director, Global Quality Solutions
Washington, DC jobs
- Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality's processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams.
- The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes.
- The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art data insights.
- The Sr. Director brings industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver a strategic roadmap that will bring and maintain Otsuka's Quality Knowledge and Document Management practices to a best in class - digitalized landscape.
Key job responsibilities
- Develop a roadmap to drive Knowledge Management to an automated, digitized and ever-green environment
- digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive.
- Applying technology intelligence and understanding of the process enhancement requirements, determine opportunities for optimization of existing systems and identifying the need for new solutions
- Addressing digitization of paper documents across the ecosystem of GQ to enable e-archiving and e- access and retrievability.
- Design and employ a digital and automated GQ work flow across the enterprise of the GQ business function.
- Drive a culture of Quality Innovation awareness
- Benchmarking external opportunities and innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology to drive optimal operational efficiency and effectiveness.
- Collaborate with external parties to understand the current industry landscape and endorse/apply best in class practices and solutions to Otsuka GQ system portfolio and business operations.
- Lead the design and execution of complex GQ optimization initiatives; including - detailed program planning, well-defined business cases, clear value proposition, the management of applicable collaborators and identification/leveraging of applicable external expertise.
- Evaluate, measure and document time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time.
- Identify and pursue opportunities through internal and external collaborations to optimize Knowledge and Document Management, GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities.
- Travel (approximately 10-25%)
Qualifications
- Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 5 years of applicable health care, technology or industry is experience strongly preferred.
- Advanced analytic skills, and general understanding of the drug development and regulatory process.
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to credibly, knowledgeably and effectively represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka's partners and clinical trial personnel.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka's competitive edge.
- Ability to work effectively in a matrixed, multi-cultural, collaborative and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
**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 $205,368.00 - Maximum $307,050.00, 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.
Senior Director, Field Force Operations
Boston, MA jobs
Vertex is seeking an experienced commercial leader to lead North America's Field Operations team. The Senior Director, Field Force Operations will partner with Business Unit leaders and cross-functional stakeholders to enable and support all of North America's commercial field forces. This role reports to the Executive Director, North America Commercial Operations & Insight Analytics.
Key Duties & Responsibilities
* Develops and implements industry best practices for sales force field enablement for launch and in-line brands
* Lead a team of field operations personnel and contingent workers
* Responsible for providing input into the field incentive compensation (IC) design with BU stakeholders. Manage the administration of the field IC program (i.e. IC reports for field teams, HQ dashboards, etc.), prepare and coordinate IC payments, ensure IC plans are compliant in aligned to Vertex principles, perform periodic IC plan "health checks," maintain detailed set of IC documentation and business rules, etc.
* Establishes and maintains field force sizing, territory alignments and HCP targeting
* Designs and maintains field sales force and field sales management reporting dashboards, including but not limited to product sales tracking, incentive compensation, and field activities
* Designs and maintains the customer relationship marketing tool and partner with cross-functional stakeholders to maximize efficiency and utility and seamless customer interactions
* Manages the vehicle fleet program for all field base personnel (including non-sales personnel)
* Manages the field sales force credentialling program
* Manages the product sampling program in line with industry policies and regulations governing sample accountability
* Build a strategy to strengthen and build Vertex's external footprint across therapeutic areas within the current/future portfolio
* Ability to support multiple sales teams across small molecule and gene therapy disease areas
* Plan for scaling and growth of the North America commercial organization to match increasing number of indications and launches
* Key member of cross-functional team to design and implement incentive compensation program including measurement components, quotas, award programs and contests
* Collaborates with information technology team (DTE) and Business Information teams to oversee construction/management of data infrastructure and ongoing enhancements based on business needs; establishing policies and procedures to maintain integrity of data and ensure compliance with PDMA, AMA, and other regulations
* Ensures data integrity of external and internal data sources used to support Sales, Marketing, Market Access, and Medical Affairs groups
* Designs, documents, and maintains policies and procedures for areas of responsibility
* Manages vendors and services within assigned budgets that enable the field force readiness to be more effective while ensuring quality deliverables
* Manages team members to ensure career development and quality field enablement related deliverables
* Completion of ad-hoc projects and analysis relating to Field Operations group responsibilities
Required Education and Experience
* Bachelor's degree (BS/BA in Business/Finance, Mathematics, Sciences or equivalent, etc.)
* Typically requires 10 + years of pharmaceutical/biotech/consulting industry experience in related area of responsibility and 5 years of supervisory / management experience, or the equivalent combination of education and experience
Required Knowledge/Skills
* Experience in managing projects related to pharmaceutical/biotech sales force sizing, field force reporting, data management, and incentive compensation
* Excellent project management and interpersonal/communication skills in leading and directing teams to achieve project objectives and goals within assigned timelines
* Understands and adheres to policies that regulate pharmaceutical Sample Accountability
* Thorough understanding of sales data tracking systems, processes, and methodologies
* Highly effective presentation skills, written and verbal communication skills
* Strong analytical skills, demonstrated by the ability to identify and understand complex issues and problems within product sales and prescriber information data sets
* Demonstrated ability to work independently and manage multiple projects that require collaboration across functional areas
* Team player able to develop rapport and credibility with field and home office personnel including management
* Experience with CRM systems (i.e. Veeva, Salesforce.com, etc.)
* Experience with IQVIA DDD and Xponent data sets
* Experience in Specialty Pharmacy data sets
* Knowledge of Patient level de-deidentified data sets
Pay Range:
$223,200 - $334,800
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyBusiness Unit Director
Philadelphia, PA jobs
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Objective:**
Develop the customer relationship through Customer Focused teams of dedicated employees to provide an 'industry leading customer experience'. Develop specific customer strategies with the Account Executive and monitor attainment of projects and goals. Provide leadership and direction to the teams to ensure the groups are performing within prescribed timelines and budget. Collaborate with other BUD's and internal departments to ensure the use of best practices within appropriate guidelines.
**Essential Duties & Responsibilities:**
+ Interact with other business units and functional departments to define production plans, yearly goals and budgets.
+ Establish business unit and individual goals and objectives in alignment with site goals and customer requirements.
+ Primary customer contact for business and relationship issues.
+ Manage short-term and long-term customer forecasts.
+ Quarterly customer meetings/business reviews: accountable for meeting, success, develop agenda, coordinate meeting details with customer and PCI internal staff, lead the organization in detail preparation, lead meetings, insure professional follow-up on all open items
+ Oversee business and quality issues.
+ Manage customer visits to PCI.
+ Adherence to PCI and cGMP policies, procedures, rules and regulations.
+ Attendance to work is an essential function of this job.
+ Other duties as assigned by Supervisor/Manager.
**Core Attributes:**
+ Act as a positive role model that accomplishes and supports management objectives and diversity.
+ Assists in diffusing conflicting situations. Communicates clear directions and holds employees accountable.
+ Celebrates and rewards significant achievements of others.
+ Builds trusting coaching relationships.
+ Helps people assess their skills and identify development objectives.
+ Ensure annual performance reviews are written for each employee within reporting structure. Complete and submit documentation, as necessary, for any required human resource actions.
**Supervisory Responsibilities:**
+ Supervise approximately two or more associates within the Project Management function.
+ Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
+ Responsibilities include interviewing, hiring, and training employees; staffing, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
**Qualifications:**
This position requires a history of project accomplishments and demonstrated leadership excellence preferably as a project manager at PCI. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Minimum four years' experience in the pharmaceutical and/or packaging industry or a related field, with a history of project accomplishment and leadership excellence in the project management arena. Preferred packaging and/or pharmaceutical experience.
+ Bachelor's or Master's degree from four-year college or university; Packaging Science degree preferred.
+ Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project, and a working knowledge of GMPs.
+ Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
+ Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
+ Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
+ Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
**\#LI-JM1**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Director, R&D Data Stewardship
Pennsylvania jobs
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
We are looking for a Director R&D Data Stewardship to join the team.
Main Responsibilities:
Lead the implementation of data management frameworks, standards and best practices across selected R&D domains (e.g., Research, Clinical, Safety, Regulatory)
Coordinate with data owners, enterprise governance and Data Excellence/TES teams to ensure consistent data definitions, quality rules and metadata management.
Manage adoption of data standards, ontologies and controlled vocabularies across R&D data platforms & scientific systems.
Support integration of data management principles into data platforms and workflows in partnership with IT and platform teams.
Manage external stakeholders and partners to ensure data quality, compliance to standards, and adherence to contract & data-sharing agreements.
Monitor data stewardship KPIs and data quality metrics, lead remediation and optimization efforts.
Mentor data stewards and contribute to training and change management activities.
Promote data management as a foundational capability across the R&D organization.
Skills & Qualifications:
Bachelor's or Master's degree in Life Sciences, Information Science or related field.
10+ years of experience in data stewardship, data governance or data management in Biomedical R&D.
Experience managing data across Research, Clinical, Safety, and/or Regulatory domains, with deep understanding of data standards, governance frameworks, compliance requirements, and cross-functional data integration.
knowledge of FAIR data principles and regulatory requirements.
Working knowledge of data governance tools (e.g., CENtree, Collibra, Informatica, Alation).
Experience with cloud data infrastructure and scientific data systems (ELN, CTMS, CDMS, Safety DB, RIM)
Strong stakeholder engagement and project leadership skills.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
Auto-ApplyDirector of External Research & Development
Washington, DC jobs
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Director of External Research & Development -** **Technology Business Development**
**What you will do**
Let's do this! Let's change the world! In this vital role you as the Business Development Director within the External R&D Technology group, this role is responsible for leading Amgen's search and evaluation, as well as negotiate and execute on certain transactions, for external partnerships focusing on small molecule drug discovery, as well as technologies that support oncology therapeutic area. Collaborating with cross-functional teams to ensure alignment with the business's broader goals will also be a critical part of your role.
The successful candidate will contribute to and execute on Amgen's external strategy and develop and nurture a global network of key industry and academic contacts to ensure robust communication of ideas, interests and information between the external community and internal groups.
The role requires proactive efforts to manage the search and identification of opportunities through networking and reviews of the external landscape and prioritizing based on Amgen's R&D strategy. The role includes leading the technical evaluations of opportunities by creating and managing cross-functional review teams, providing recommendations based on robust scientific and drug industry knowledge, and ensuring appropriate and efficient decision-making processes. This person will ensure efficient reviews and engage in business negotiations, and working with the legal team to execute contractual agreements for certain projects. The candidate will be responsible for leading strategic discussions and presentations, collaborating closely with senior management, R&D, and other functions to develop a set of priorities for collaboration, license, or M&A of external innovation. The Director of External Research & Development - Technology Business Development will also be expected to contribute in search and evaluation and transactions for technology areas outside of small molecule drug discovery and oncology, as needs arise, as well as mentor others and present himself/herself as a thoughtful and respected professional to both internal colleagues and external parties.
It's highly preferred that this role be located at an Amgen Research hub in either South San Francisco, CA or Thousand Oaks, CA to match most of our research teams.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Director of External Research & Development - Technology Business Development will have these qualifications.
**Basic Qualifications:**
Doctorate degree in a scientific field & 4 years of experience in drug development industry and/or biopharma business development
**Or**
Master's degree in a scientific field & 7 years of experience in drug development industry and/or biopharma business development
**Or**
Bachelor's degree in a scientific field & 9 years of experience in R&D and/or biopharma business development
**Preferred Qualifications:**
+ Doctorate in scientific field, with strong knowledge in discovery and technology platforms
+ 4+ years of management and/or leadership experience in business and drug development activities, and strong technical R&D experience along with business development and licensing experience.
+ Strong leadership, scientific, organizational, communication, and project management skills and ability to manage multiple projects simultaneously.
+ Excellent presentation skills. Effective communication skills pertaining to scientific and business development. Must demonstrate ability to foresee and solve problems, and prioritize and meet deadlines. Strong team player, experience in successfully managing direct reports and a demonstrated ability to interface effectively with all-levels of staff across differing functional expertise.
+ Demonstrated ability to create and establish relationships with internal and external parties.
+ Professional demeanor with strong decision making
+ Be able to work independently, manage large cross functional teams, and mentor individuals.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Application deadline**
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.