Associate Director, CMC - Pharma Product Group

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.

Zenas BioPharma is a forward-thinking clinical-stage global biopharmaceutical company dedicated to leading the development and commercialization of groundbreaking therapies for patients suffering from autoimmune diseases. Our strategy leverages the expertise of our seasoned leadership team combined with a meticulous approach to the acquisition and development of product candidates that we believe will provide significant clinical advantages for patients with autoimmune disorders. Zenas is actively progressing two late-stage potential franchise molecules: obexelimab and orelabrutinib. Obexelimab—our flagship product candidate—is a bifunctional monoclonal antibody engineered to bind to both CD19 and FcγRIIb, which are extensively expressed across B cell lineages. This innovative approach aims to inhibit the activity of cells involved in various autoimmune diseases without depleting them. We are confident that obexelimab’s unique mechanism of action and its self-administered, subcutaneous injection regimen will effectively target the harmful role of B cells in chronic autoimmune conditions. Orelabrutinib is a potentially best-in-class, highly selective oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to address focal inflammation and disease progression in Multiple Sclerosis (MS). Our earlier-stage programs include a preclinical oral IL-17AA/AF inhibitor and a preclinical oral brain-penetrant TYK2 inhibitor.We are in search of exceptional talent who are passionate about making a difference in patients' lives and possess a proven track record in the global acquisition, development, and commercialization of pharmaceutical products. Joining our team offers the chance to thrive in a dynamic, fast-paced environment while contributing to our mission of becoming a global leader in immunology and autoimmune disease treatment. Our core values are Transparency, Relationships, Urgency, Excellence, and true Innovation!Position Summary:The Senior Director of Access Strategy & Patient Services will be pivotal in strategizing and leading our patient access initiatives, ensuring smooth operations for patient services to facilitate timely and appropriate access to Zenas BioPharma therapies. Reporting directly to the Vice President of U.S. Market Access, this role will oversee the development of the patient journey strategy, the HUB services model, affordability programs, and the onboarding processes for providers to help both patients and providers navigate access to therapy effectively.This role is crucial in establishing the patient access infrastructure ahead of significant product launches, operationalizing the patient support HUB, and designing prior authorization support systems to enhance patient access.

As the Director of Market Access Pricing & Analytics, you will play a pivotal role within our US Market Access team. This leadership position is essential for delivering impactful insights that shape our pricing, contracting, and reimbursement strategies. You will leverage advanced analytics, strategic acumen, and cross-functional collaboration to support key business decisions aimed at enhancing patient access. In this role, you will identify opportunities, evaluate risks, align stakeholders, and translate data into actionable strategies to achieve our market access objectives.

Join ServiceNow as the Director of Monetization Strategy, where you will spearhead innovative approaches to maximize our revenue streams and enhance customer satisfaction. In this pivotal role, you will collaborate with cross-functional teams to develop strategic frameworks and drive our monetization initiatives. Your expertise will ensure that our products not only meet market demands but also exceed our financial targets.

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.

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, 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.

Join Our Growth Team as a Strategy AssociateEvolv Technology is on the lookout for a dynamic and adaptable strategist to elevate our Growth Team. In this pivotal role, you will contribute to the advancement of Evolv by pinpointing new market opportunities, crafting plans for market entry and expansion, and spearheading strategic initiatives aimed at broadening our business footprint. A primary focus will be establishing a program that promotes the responsible adoption of cutting-edge safety technology across key sectors. Your responsibilities will include coordinating evidence development, securing third-party validation, stakeholder mapping, and engaging with standards organizations, all while cultivating trustworthy relationships with customers, industry associations, and research partners. This position demands structured thinking, exceptional writing and communication skills, along with the ability to navigate complex multi-stakeholder environments.Why Choose Evolv?At Evolv, we are dedicated to enhancing public safety through groundbreaking security technology. We value individuals who consistently do the right thing, prioritize people, take ownership, collaborate effectively, and embrace boldness and curiosity. Our comprehensive benefits package includes equity options, extensive health coverage, a 401(k) plan with matching contributions, flexible paid time off, tuition reimbursement, a quarterly well-being stipend, and access to mental wellness resources like Calm.Your Success Path:In your first 30 days, you will:Gain an understanding of our business across various vertical markets, assess the impact of our products on customers, and identify growth opportunities.Within 90 days, you will:Map the current landscape of federal and state regulations, best practices, mandates, and policies influencing weapons detection.Identify existing and forthcoming legislation and funding, along with approaches taken by other companies in the weapons detection sector.Select federal and state agencies, and formulate a tailored plan for Evolv, including specific agencies, messaging, and success metrics.By the end of 12 months, you will:Have a comprehensive understanding of the regulatory and funding landscape at the federal and state levels and a system in place for tracking and monitoring changes.Engage with targeted agencies to advance policy, best practices, and funding initiatives for weapons detection.Create a set of evidence-based outcomes from our products for customer use, and devise a strategy to develop additional proof points.

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics that aim to set a new standard for treating chronic skin conditions. The company’s mission centers on helping patients with diseases like plaque psoriasis achieve lasting relief and, in some cases, complete disease clearance with infrequent dosing, potentially just once or twice a year. Oruka’s pipeline features proprietary antibodies, engineered by Paragon Therapeutics, that target the underlying mechanisms of plaque psoriasis and other dermatologic and inflammatory disorders. More information is available at www.orukatx.com. Position Details Title: Associate Director of Clinical Operations Location: Waltham, Massachusetts (hybrid schedule: 3 days per week onsite) Role Overview Oruka Therapeutics seeks an Associate Director of Clinical Operations to manage all aspects of trial setup and execution. This role supports the Director of Clinical Operations within a designated therapeutic area and involves oversight of multiple studies. The position calls for someone who can balance strategic planning with hands-on involvement, ensuring clinical programs stay on schedule and within budget. The Associate Director will handle operational details, anticipate and address challenges, and implement solutions to keep trials moving forward. Success in this role requires integrity, practical judgment, and a strong commitment to study goals. The ability to shift between leadership and direct involvement, a true player/coach approach, is essential. This is a hands-on, collaborative role within a biotech setting that values adaptability and resourcefulness. The environment offers frequent opportunities for learning and growth alongside a team committed to a positive and inclusive culture.

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.

Who We Are: Cogent Biosciences is a leading biotechnology company publicly traded and dedicated to developing innovative precision therapies to address significant medical needs. Our flagship program, bezuclastinib, effectively targets exon 17 mutations in the KIT receptor tyrosine kinase, including the KIT D816V variant, which is linked to Systemic Mastocytosis and gastrointestinal stromal tumors (GIST). With encouraging data from multiple clinical trials, including APEX, SUMMIT, and PEAK, bezuclastinib demonstrates a strong safety profile and potential for positive patient outcomes. The Role: We are looking for compassionate and driven Patient Access Navigators to pioneer our Patient Services team. As a Patient Access Navigator, you will be instrumental in providing a comprehensive, patient-centered access experience throughout the prescription fulfillment process. You will manage the entire patient journey in your designated geographic area and collaborate closely with patients, caregivers, healthcare providers (HCPs), specialty pharmacies, and internal and external partners to ensure timely access to therapies and continuity of care. Although this role is primarily home-based with occasional office visits at our Waltham Headquarters (two days a week), you will be expected to support complex access, reimbursement, or care coordination needs as required. We seek team members who are empathetic, detail-oriented, and committed to operational excellence as we prepare for the launch of bezuclastinib.

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.

Who We Are:Cogent Biosciences is a publicly traded biotechnology firm dedicated to pioneering innovative precision therapies aimed at addressing diverse patient needs in the medical field. Our flagship program, bezuclastinib, is engineered to selectively and effectively inhibit exon 17 mutations present in the KIT receptor tyrosine kinase, notably including KIT D816V. This mutation is a primary driver of Systemic Mastocytosis, a rare and serious disease, while exon 17 mutations are also implicated in gastrointestinal stromal tumors (GIST), a cancer type reliant on aberrant KIT signaling. Bezuclastinib has demonstrated promising outcomes in early trials: APEX in AdvSM, SUMMIT in NonAdvSM, and PEAK in GIST, showcasing a favorable safety profile across more than 600 patients in both standalone and combination therapies.Position Overview:The National Account Director (NAD) is tasked with securing profitable coverage access with national payer organizations, including GPOs, PBMs, and major regional account clients.This role is pivotal in executing our Market Access objectives and strategies directed at the payer audience.The NAD will collaborate with various internal teams such as Market Access, Marketing, Commercial Operations, Sales, and Medical to align strategies with our key clients, ensuring optimal experiences for both patients and providers.Key Responsibilities:Implement tailored customer strategies that align with our overall product and business objectives.Communicate the value of our offerings by managing relationships with all customer stakeholders.Design and execute corporate strategies tailored to the market access payer landscape, maximizing Cogent's access and profitability.Lead discussions with key strategic accounts, including clinical and contracting negotiations as necessary.Stay informed on developments among government and private insurers to inform Market Access strategies, enabling proactive responses to market changes.Establish, nurture, and expand relationships with senior executives at key accounts.

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 seeking a dynamic and strategic leader to join our team as the Vice President of US Market Access. In this pivotal role, you will be responsible for developing and executing comprehensive market access strategies that ensure our innovative therapies reach the patients who need them. You will collaborate closely with cross-functional teams, including commercial, medical affairs, and regulatory, to optimize the market positioning and reimbursement landscape for our product portfolio.The ideal candidate will possess deep expertise in market access, payer strategy, and the pharmaceutical industry landscape. You will leverage your leadership skills to drive initiatives that enhance our market presence and ensure the successful launch of our products in the US market.