Associate Director, CMC - Pharma Product Group

Role Overview AbbVie Inc. is hiring an Associate Director for the CMC - Pharma Product Group in Waltham. This leadership position guides pharmaceutical product development from early concept through commercialization. The Associate Director oversees cross-functional teams, ensuring projects meet quality standards and advance on schedule. Key Responsibilities Lead and coordinate teams across multiple functions to deliver pharmaceutical products. Drive product development activities from initial idea through market launch. Ensure delivery of high-quality products that meet regulatory and company standards.

AbbVie is seeking an accomplished Associate Director in Regulatory Affairs CMC to lead and oversee regulatory strategies for our product portfolio. In this role, you will be responsible for the preparation and submission of regulatory documents, ensuring compliance with evolving regulations and guidelines.You will collaborate with cross-functional teams, providing expertise in CMC (Chemistry, Manufacturing, and Controls) regulatory matters while driving initiatives that align with our company’s mission to advance patient care.The ideal candidate will possess a strong background in regulatory affairs within the pharmaceutical or biotechnology industry, with proven experience in product submissions to regulatory authorities.

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.

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.

The Associate Director of Commercial Effectiveness & Training will play a pivotal role in designing and delivering impactful training programs aimed at enhancing the knowledge and competencies of customer-facing teams, including Field Sales, Account Managers, and Infusion Educators. Reporting directly to the Director of Commercial Effectiveness & Training, this position is crucial in preparing Sobi for the anticipated product launch in 2026.Collaborating closely with Field Leadership, the Brand Team, and various cross-functional partners, the Associate Director will spearhead the planning and execution of onboarding training initiatives that equip teams for launch readiness and long-term success.Preference will be given to candidates based in the Boston area.Key Responsibilities:Coordinate and facilitate new hire training sessions, both virtual and in-person.Develop, implement, and facilitate training programs and workshops for National Sales and Plan of Action (POA) meetings as necessary.Identify learning gaps and collaborate with the Director of Commercial Effectiveness & Training to create effective content aimed at improving outcomes for our field teams.Oversee processes related to the Medical, Legal, and Regulatory review of training materials.Perform additional duties as assigned.

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.

Join Sobi as an Associate Director of Access Strategy, where you will play a critical role in shaping access strategy initiatives that enhance patient access to innovative therapies. Collaborate with cross-functional teams to develop comprehensive strategies that address barriers to access and ensure that patients receive the treatments they need. Your expertise will influence strategic decision-making and drive successful outcomes in the evolving healthcare landscape.

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.

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.

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.

Role Overview ServiceNow is seeking a Product Success Technical Director focused on CRM in Waltham. This leadership role centers on advancing product success for customers by aligning technical expertise with real-world needs. The position calls for a strong mix of technical understanding and customer focus. What You Will Do Lead efforts to improve CRM product outcomes for customers Translate technical insights into practical solutions that address customer requirements Drive customer engagement and satisfaction through targeted initiatives What Matters for Success Deep knowledge of CRM systems and technical best practices Ability to connect technical details with customer needs Strong leadership in guiding teams and initiatives

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.

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.

About Crescent Biopharma Crescent Biopharma focuses on developing oncology therapies aimed at improving outcomes for cancer patients. The company’s clinical-stage pipeline includes a PD-1 x VEGF bispecific antibody and advanced antibody-drug conjugates. By working across multiple therapeutic approaches and known targets, Crescent Biopharma advances treatments for solid tumors, both as standalone options and in combination regimens. Learn more at www.crescentbiopharma.com, or connect on LinkedIn and Twitter. Role Overview: Associate Director of Financial Planning & Analysis Based in Waltham, MA, the Associate Director of Financial Planning & Analysis (FP&A) supports both corporate and program-level financial planning, budgeting, and forecasting. This position works closely with teams such as R&D and Program Management to help guide financial decisions and support the company’s strategic direction.

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.

Deciphera Pharmaceuticals is looking for a dynamic and strategically minded Associate Director of Global Site Contracts, Budgets, and Payments to spearhead our global site contracting and investigator grant initiatives across our clinical programs. This pivotal role is essential for ensuring the timely initiation and execution of studies by providing finalized site agreements, budgets, and payment plans that are in sync with corporate and program timelines. Key Responsibilities:Act as the go-to expert and primary point of escalation for global site contracts, budgets, and payments.Lead the creation of investigator grant budgets, payment terms, and contracting strategies.Manage contract tracking, documentation, and compliance within our internal systems and with external partners.Offer oversight and support to study teams and CROs during feasibility, startup, maintenance, and closeout phases.Collaborate across functions with Clinical Operations, Legal, Compliance, Finance, and CROs to facilitate efficient study startup and lifecycle execution.Participate in bid defenses, joint operating committees (JOCs), kickoff meetings, and other program discussions.Drive department initiatives, implement process enhancements, and mentor team members.Willingness to travel up to 25% as required.

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.