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Experience Level
Experience
Qualifications
We are looking for candidates with a robust background in pharmacovigilance or drug safety, ideally with a Master’s degree or higher in a relevant field. A minimum of 5 years of experience in the pharmaceutical industry is required, with a strong emphasis on regulatory compliance and reporting. You should possess excellent analytical skills, attention to detail, and the ability to work collaboratively in a fast-paced environment.
About the job
As the Associate Director of Pharmacovigilance, you will play a crucial role in ensuring the safety and efficacy of our pharmaceutical products. You will lead a team dedicated to monitoring and evaluating adverse drug reactions, while also collaborating closely with regulatory bodies to uphold our commitment to patient safety. Your expertise will contribute significantly to our ongoing efforts in drug development and post-marketing surveillance. Join us in making a difference in the lives of patients around the world.
About Deciphera Pharmaceuticals, Inc.
Deciphera Pharmaceuticals, Inc. is at the forefront of transforming the treatment landscape for patients with cancer. We focus on developing innovative therapies that target the underlying mechanisms of disease. Our commitment to scientific excellence and patient safety drives our work, and we are seeking passionate individuals to join our mission.
Join AbbVie as an Associate Director in our CMC-Pharma Product Group, where you will play a pivotal role in leading cross-functional teams to drive the development and manufacturing of high-quality pharmaceutical products. Your expertise will be crucial in ensuring compliance with regulatory standards and enhancing our product portfolio.
Join AbbVie as an Associate Director in Regulatory Affairs with a focus on Chemistry, Manufacturing, and Controls (CMC). In this pivotal role, you will lead cross-functional teams to ensure compliance with regulatory requirements while advancing our innovative therapies. As a leader, you will drive the development of CMC submission strategies, collaborate with internal and external stakeholders, and support the overall regulatory strategy for our product pipeline.
Full-time|$213K/yr - $286K/yr|Hybrid|Waltham, Massachusetts, United States
Join Our Mission:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing cutting-edge biologics aimed at revolutionizing the treatment of chronic skin diseases. Our commitment is to provide patients afflicted by conditions such as plaque psoriasis with unprecedented freedom by achieving significant disease clearance with infrequent dosing—sometimes as little as once or twice a year. We are advancing a proprietary pipeline of potentially best-in-class antibodies that target the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory ailments. Discover more about us at www.orukatx.com.As we expand our core team, we are looking for exceptional individuals who are not just seeking employment but are passionate about contributing to a broader cause. We value candidates who are eager to foster an inclusive and dynamic company culture.Position Overview:We are in search of a seasoned and motivated leader in regulatory CMC to shape our strategy and execution across various stages of biologics programs. In this role, you will be responsible for the development of high-quality regulatory CMC submissions and will provide guidance to cross-functional teams on global regulatory expectations appropriate for different phases. Ideal candidates will bring extensive expertise in biologics development and manufacturing, particularly in drug substance and product CMC submissions. You will play a crucial role in influencing program strategies, facilitating collaboration across CMC, QA, RA, Supply Chain, and external partners, and driving pivotal decisions that support our expanding biologics pipeline. This highly visible role involves ensuring compliance with FDA, EMA, ICH, and WHO guidelines while meeting corporate and program-level objectives.
We are seeking a skilled and experienced CMC Regulatory Affairs Manager to join our dynamic team. In this pivotal role, you will oversee the regulatory strategy and submissions related to Chemistry, Manufacturing, and Controls (CMC) for our biopharmaceutical products. Your expertise will ensure compliance with regulatory requirements and support the successful development of our innovative therapies.
Full-time|On-site|Waltham, Massachusetts, United States
Join ZoomInfo as the Director of Product Strategy, where you will lead our product vision and strategy to drive product innovation and customer satisfaction. You will collaborate with cross-functional teams to define and execute product roadmaps, ensuring alignment with business goals and market needs.
At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.
Zenas Bio Pharma is a pioneering clinical-stage biopharmaceutical company that aims to lead the way in the development and commercialization of life-changing therapies for patients suffering from autoimmune diseases. Our strategic approach leverages a seasoned leadership team and a meticulous candidate acquisition process to globally identify, acquire, and develop innovative products that can significantly improve the quality of life for individuals with autoimmune conditions. We are currently advancing two late-stage potential franchise molecules: obexelimab and orelabrutinib. Obexelimab is Zenas' flagship product, a bifunctional monoclonal antibody designed to target CD19 and FcγRIIb, which are key players in B-cell mediated autoimmune disorders, allowing us to inhibit harmful cellular activity without depleting these critical cells. We believe obexelimab's unique mechanism and its self-administered subcutaneous injection format may provide a comprehensive solution for chronic autoimmune diseases. Orelabrutinib, on the other hand, is a highly selective, CNS-penetrant oral Bruton’s Tyrosine Kinase (BTK) inhibitor, showing promise in managing inflammation and disease progression in Multiple Sclerosis (MS). Our portfolio also includes earlier stage programs featuring innovative oral inhibitors for IL-17AA/AF and TYK2.We are on the lookout for exceptional talent who share our dedication to patient care and have a proven history of successfully acquiring, developing, and commercializing pharmaceutical products worldwide. Join us in a dynamic and fast-paced environment where individual and collective success is paramount as we strive to establish ourselves as a global leader in immunology and autoimmune disease treatment, embodying our core values of Transparency, Relationships, Urgency, Excellence, and TRUE Innovation!Position Summary:The Director of Training is responsible for setting the vision, strategy, and execution of Zenas Bio Pharma's training initiatives. This role ensures that all commercial field-facing teams are thoroughly equipped with the necessary knowledge, skills, and competencies to excel in their roles. The Director will oversee the creation, integration, and ongoing enhancement of training frameworks, curricula, digital learning resources, and capability-building initiatives that facilitate both initial onboarding and continuous professional development across all commercial functions related to Account Management.The Director will also provide strategic oversight of vendors and training partners to guarantee consistency, quality, and alignment across the commercial field. Additionally, this position will involve collaboration with Commercial Leadership, Medical Leadership, Compliance, and various other functional teams to optimize training effectiveness.
Deciphera Pharmaceuticals is hiring a Director of New Product Planning in Waltham. This role is part of the Global Marketing Department and centers on guiding strategy and execution for new product initiatives. The Director will influence how new therapies progress from initial concept to market introduction, working to align efforts with company goals and a commitment to patient outcomes. What you will do Lead strategic planning for new product launches and related initiatives. Coordinate and guide cross-functional teams through all stages of the product development process. Drive projects that support Deciphera's objectives and contribute to advancing patient care.
As the Associate Director of Pharmacovigilance, you will play a crucial role in ensuring the safety and efficacy of our pharmaceutical products. You will lead a team dedicated to monitoring and evaluating adverse drug reactions, while also collaborating closely with regulatory bodies to uphold our commitment to patient safety. Your expertise will contribute significantly to our ongoing efforts in drug development and post-marketing surveillance. Join us in making a difference in the lives of patients around the world.
As the Associate Director of Access Strategy at Sobi, you will play a pivotal role in shaping the strategies that enhance patient access to our innovative therapies. This position requires a strategic thinker who is passionate about improving healthcare accessibility and is adept at navigating the complexities of the healthcare landscape. You will work closely with cross-functional teams to develop and implement access strategies that align with our organizational goals and promote patient-centric outcomes.
Deciphera Pharmaceuticals, Inc. is on the lookout for a seasoned Associate Director of Sales Operations to spearhead and enhance our field-facing operational strategies. This pivotal role will support the establishment of a high-performing Commercial field team, particularly focused on facilitating a successful brand launch. The successful candidate will ensure compliance, efficiency, and data-driven insights within field operations across our Hematology Franchise, playing a crucial role in ensuring operational readiness for product launches and ongoing excellence initiatives in the field.Key ResponsibilitiesFormulate and implement field operations strategies that align with both commercial and medical objectives.Manage field technology platforms including CRM systems, roster management, and reporting tools in collaboration with the IT department.Oversee territory design, roster management, and alignment processes to ensure compliance with coverage models.Coordinate onboarding operations with Training, HR, and Compliance teams.Direct the creation of field reports, dashboards, KPI tracking, and business insights.Ensure all field operations processes adhere to FDA, OIG, and corporate compliance standards.Lead continuous improvement initiatives aimed at enhancing scalability, efficiency, and quality.Collaborate effectively across functions including Sales, Marketing, Medical, Compliance, IT, HR, Legal, and Finance.
ServiceNow is hiring a Product Success Technical Director with a focus on CRM, based in Waltham. This leadership position plays a key role in helping customers achieve better results from their CRM products by combining technical expertise with a strong customer perspective. Role overview This role centers on improving product outcomes for customers. The director will use technical knowledge to address real-world challenges and ensure that solutions meet customer requirements. What you will do Lead efforts to enhance CRM product results for customers Translate technical insights into practical solutions tailored to customer needs Drive customer engagement and satisfaction through focused initiatives Requirements Extensive knowledge of CRM systems and technical best practices Skill in connecting technical details with customer needs Proven leadership in guiding teams and projects
Full-time|$182K/yr - $208K/yr|Hybrid|Waltham, Massachusetts, United States
Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.
Deciphera Pharmaceuticals is excited to invite applications for the role of Associate Director of Program Leadership & Management. In this pivotal position, you will provide exceptional leadership and strategic direction to our Development and Commercial Program Teams. Collaborating closely with the Program Lead, you will be instrumental in advancing programs from early to late-phase clinical development and lifecycle management. The ideal candidate will exhibit a comprehensive understanding of drug development, thrive in ambiguous situations, and possess outstanding communication skills to foster effective collaboration within program teams and across the organization.This role demands a high level of cross-functional teamwork, engaging with both internal and external partners. You will be responsible for leading daily program management activities, including the formulation and implementation of the program's Integrated Development Strategy. A deep understanding of overall program strategy and critical path activities, as well as risk identification and mitigation planning, is essential.Key ResponsibilitiesStrategic Partnership with the Program Lead (50%)Collaborate with the Program Lead to develop and execute strategic, integrated development plans through effective leadership of Program Teams.Provide clear guidance on product development requirements to align with the expectations of external customers and business stakeholders.Monitor program progress and related KPIs, identifying gaps and risks while offering strategic recommendations.Support the execution and ongoing reassessment of development strategies in line with the overall corporate strategy.Operational Excellence Across Program Teams (50%)Facilitate program team meetings to ensure productive and efficient discussions.Ensure timely and clear communication of program strategies and progress to relevant stakeholders.Coordinate the integration of sub-teams to enhance the effectiveness of Program Teams.
Full-time|$175K/yr - $200K/yr|Hybrid|Waltham, Massachusetts, United States
About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics aimed at revolutionizing the treatment of chronic skin disorders. Our mission is to empower patients suffering from conditions such as plaque psoriasis by providing opportunities for significant disease clearance with minimal dosing frequency, potentially just once or twice a year. Leveraging a unique portfolio of advanced antibodies engineered by Paragon Therapeutics, we target the fundamental mechanisms contributing to plaque psoriasis and other dermatologic and inflammatory conditions. Learn more about our vision at www.orukatx.com.As we expand our core team, we are seeking passionate professionals who aspire to be part of a transformative journey, not just a job. If you are eager to make a positive impact and contribute to a vibrant, inclusive company culture, we want to hear from you.Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)Location: Hybrid – Waltham, MA, with a requirement to be in-office 3 days a week.Position Overview:We are looking for a dynamic and skilled leader in Manufacturing Science and Technology (MSAT) to spearhead downstream late-stage and pivotal optimization, scale-up, and transfer of manufacturing processes. In this role, you will be responsible for process development, troubleshooting production challenges, data analysis, and ensuring adherence to regulatory standards to uphold product quality. The successful candidate will play a critical role in late-stage drug substance manufacturing and process validation activities to support BLA submissions. This position requires adaptability in a fast-paced environment, along with the ability to draft high-quality reports, finalize source documents, and actively participate in regulatory submissions. Join us as a vital member of a growing team dedicated to advancing best-in-class biotherapeutics.
The Associate Director of Financial Planning & Analysis at Crescent Biopharma is based in Waltham, MA. This role plays a key part in shaping financial planning at both the corporate and program levels, with a focus on budgeting and forecasting. Role overview This position partners with teams across the company, including R&D and Program Management. The Associate Director helps guide financial decisions that support Crescent Biopharma’s strategic goals and ongoing projects. What you will do Lead corporate and program-level budgeting and forecasting processes Collaborate with cross-functional teams to provide financial insight and analysis Support strategic planning by delivering accurate financial data and recommendations Location This role is located in Waltham, MA.
Are you looking for an opportunity to work closely with a single sponsor while benefiting from the stability and growth opportunities provided by a global CRO? Join our team at ClinChoice, where we believe it's the best of both worlds. ClinChoice is actively seeking an Associate Director of Statistical Programming for a permanent position in a hybrid work model. This role offers a unique chance to lead crucial statistical strategies within a vibrant and fast-paced environment. This position is hybrid, preferably requiring candidates to travel to our client’s location in Waltham, MA. We are looking for a seasoned Associate Director of Programming to spearhead programming initiatives, develop scalable processes, and guarantee the delivery of high-quality outputs for regulatory submissions.
Full-time|$181.6K/yr - $227K/yr|On-site|Waltham, MA
Zenas Bio is a pioneering clinical-stage global biopharmaceutical company dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune diseases. Our strategic approach is rooted in the expertise of our seasoned leadership team, combined with a rigorous methodology for acquiring and developing promising product candidates worldwide. We are advancing two late-stage molecules, obexelimab and orelabrutinib, which we believe have the potential to provide significant clinical benefits. Obexelimab, our flagship candidate, is a bifunctional monoclonal antibody targeting both CD19 and FcγRIIb, designed to inhibit the activity of B cells implicated in various autoimmune diseases while preserving them. The unique administration method of obexelimab as a self-injected subcutaneous treatment may effectively tackle the underlying mechanisms involved in chronic autoimmune conditions. Orelabrutinib stands out as a potentially best-in-class oral Bruton’s Tyrosine Kinase (BTK) inhibitor, offering a highly selective approach to managing CNS-penetrant inflammation and disease progression in Multiple Sclerosis (MS). Additionally, Zenas is developing early-stage candidates, including an innovative oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor, both showing promise in the field.We are in search of exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in the global acquisition, development, and commercialization of pharmaceutical products. Join our fast-paced environment where you will have the chance to grow both personally and professionally while contributing to our mission of leading the charge in immunology and autoimmune disease treatment, grounded in our core values of Transparency, Relationships, Urgency, Excellence, and TRUE Innovation!Territory: MidAtlantic (NY, NJ, PA, OH)Position Summary:The Associate Director, Medical Science Liaison (MSL) for Rheumatology at Zenas Bio serves as the field-based representative of our Medical Affairs team. MSLs are scientifically trained professionals with robust clinical and scientific backgrounds, committed to providing the healthcare community with balanced, scientifically rigorous information. This role reports directly to the Executive National Director of US MSLs.Key Responsibilities:Identify, establish, and nurture professional relationships with international, national, regional, and local key opinion leaders and allied healthcare professionals.
Full-time|On-site|Waltham, Massachusetts, United States
Join Acorn Product Development, a leading innovator in product design and engineering dedicated to enhancing global manufacturability. With offices strategically located in Silicon Valley, Boston, Denver, and China, we pride ourselves on our dynamic and collaborative environment.Every year, top-tier Fortune 100 and 500 companies, alongside exciting start-ups, engage Acorn to assist in the design of their latest product innovations. Our expertise spans across robotics, industrial applications, life sciences, medical devices, and consumer products.At Acorn, working as a Mechanical Engineer is not just a job; it's an opportunity to learn, grow, and make meaningful contributions within an exceptional team. If your background aligns with our needs, we are eager to connect! This is an onsite role based in our Waltham, MA office.
Full-time|$182K/yr - $240K/yr|Hybrid|Remote; Waltham, Massachusetts, United States
About Us:Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologic therapies aimed at transforming the treatment landscape for chronic skin conditions. Our mission is to empower individuals suffering from chronic skin diseases, such as plaque psoriasis, by providing unprecedented freedom from their ailments through treatments administered as infrequently as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies developed by Paragon Therapeutics, targeting the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory disorders. For more details, visit www.orukatx.comAs we fortify our core team, we are on the lookout for exceptional talent across various domains. We seek individuals who are not just looking for employment, but are eager to contribute to a larger purpose. If you are passionate about making a significant impact and are keen on fostering an engaged, inclusive, and positive workplace culture, we want to hear from you.Job Title: Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)Location: Hybrid – Waltham, MA. Candidates are expected in the office 3 days a week. Remote considerations may apply.Role Overview:The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities that support the development, validation, and lifecycle management of biologic drug products, particularly monoclonal antibodies. This position will oversee method validation and comparability initiatives essential for BLA/MAA submissions, process modifications, and commercial readiness, collaborating closely with CMC, Quality, Regulatory Affairs, and external partners.The ideal candidate is a proactive leader with extensive experience in analytical method validation, device functional testing, and regulatory frameworks for late-stage biologics. You will guide teams through intricate technical and compliance milestones, making this a highly visible role within the CMC team. Join our expanding organization and play a crucial part in supporting multiple programs’ analytical activities, facilitating the release of supplies for clinical trials, and preparing for commercialization in the US, Canada, and EU.
