Associate Director, Pharmacovigilance Scientist

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.

Join Deciphera Pharmaceuticals as a Medical Director of Pharmacovigilance, where you will play a pivotal role in ensuring the safety of our products. Reporting directly to the Senior Medical Director, this position is based in our Waltham office and is integral to our commitment to patient safety.As a Medical Director, you will oversee global pharmacovigilance activities for both marketed and investigational products. Your responsibilities will include the comprehensive review and analysis of safety data, identification of safety signals, and management of the benefit-risk profile for assigned compounds. You will keep senior management informed about safety issues and may represent Deciphera at various internal and external meetings.The ideal candidate will thrive in an entrepreneurial environment and demonstrate the flexibility to contribute to the safety understanding of our compounds throughout their lifecycle. You will engage with multiple levels of management and play a critical role in advancing our pharmacovigilance initiatives.Key Responsibilities:Lead ongoing safety surveillance, benefit-risk assessments, and risk management for assigned products.Provide pharmacovigilance expertise to support decision-making based on risk/benefit evaluations and data analysis.Conduct medical reviews of adverse event reports for both marketed and investigational products, ensuring adherence to procedures and timelines.Ensure consistent and high-quality medical interpretation in adverse event case assessments.Support cross-functional teams with protocol-related medical guidance, including safety topics and patient eligibility considerations.Contribute to the development of protocols, Investigative Drug Brochures, Informed Consent Forms, and Case Report Forms.Review trial-related adverse events and ensure consistency in assessment.Participate in team meetings and vendor discussions as necessary.Support audits and inspections as a subject matter expert for assigned programs.Provide training to team members and vendors regarding product safety and medical review processes.Complete tasks in a timely manner, notifying relevant parties of any necessary changes.Engage in scientific literature review for periodic safety reports and signal detection.

We are seeking a passionate and detail-oriented Associate Research Scientist to join our innovative team at mindlance2. In this role, you will contribute to groundbreaking research initiatives, collaborating with a team of experts to drive scientific discovery.

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.

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.

Biocytogen Boston Corp is on the lookout for a dynamic and skilled Pharmacology Scientist or Senior Scientist to enhance our preclinical research capabilities in both in vivo and in vitro settings. Our focus spans across immunology, immuno-oncology, metabolic diseases, and neurology. This position is perfect for individuals with extensive knowledge in pharmacological studies, disease model development, and cell-based assays who are excited about assessing innovative therapeutic agents for our clients.The right candidate will play a vital role in our growing CRO team, engaging in experimental work as well as strategic project management to support our biotech and pharmaceutical collaborators.Key ResponsibilitiesIn Vivo PharmacologyDesign and create animal models, conducting in vivo experiments to assess the biological effectiveness of new therapeutic compounds.Lead in vivo service projects and preclinical studies, serving as Project Manager or Study Director.Conduct animal handling, tumor inoculation, drug administration via various routes, blood and tissue collection, tumor measurements, and PK/PD studies.Develop and execute internal model-building projects while characterizing diverse humanized mouse models.Provide troubleshooting support and technical mentorship to junior team members.Work closely with the BD/Sales team to strategize client project planning and technical discussions.Deliver presentations of project outcomes to clients and internal stakeholders; draft comprehensive scientific reports and summaries.Guide and support the development of junior research associates.In Vitro and Ex Vivo PharmacologyIndependently establish, validate, and execute a wide variety of in vitro and ex vivo assays, which include:Immune cell profiling from blood and tissues.Functional assays utilizing primary cells (T cells, NK cells, macrophages).Cytokine profiling, cytotoxicity, and apoptosis assays.Innovate new assay technologies by reviewing scientific literature and adapting methodologies from partnerships and internal collaborations.Perform flow cytometry (FACS), ELISA, Western blot, qRT-PCR, and multiplex cytokine analyses.Contribute to the design and execution of in vivo pharmacology studies from an in vitro perspective.Present research results in internal meetings and contribute to external scientific discussions.

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.

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.

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.

Join the innovative team at Biocytogen, where we are dedicated to advancing the field of antibody drug development. We are actively seeking talented and driven scientists to enhance our antibody discovery team. This pivotal role focuses on optimizing therapeutic antibody binders derived from our cutting-edge RenBiologics program, which boasts a comprehensive library of therapeutic antibodies targeting a vast array of druggable genes. The ideal candidate will apply state-of-the-art antibody engineering methods to enhance binding affinity, specificity, stability, and therapeutic efficacy. Your contributions will play a vital role in the development of antibodies across multiple therapeutic domains, including immuno-oncology, inflammatory and autoimmune disorders, neurology, cardiovascular diseases, and metabolic conditions.

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.

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.

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics for chronic skin conditions. The company’s mission centers on helping patients with diseases like plaque psoriasis achieve lasting relief, aiming for high rates of disease clearance with infrequent dosing, sometimes just once or twice a year. Oruka’s portfolio features proprietary antibodies from Paragon Therapeutics that target the underlying mechanisms of plaque psoriasis and other dermatologic or inflammatory disorders. More information is available at www.orukatx.com. Role Overview: Scientist/Senior Scientist, Upstream Process Development & Manufacturing (Biologics) Oruka Therapeutics is hiring a Scientist or Senior Scientist to support upstream manufacturing operations in Waltham, Massachusetts. This position focuses on process development and the delivery of clinical trial materials produced at Contract Development and Manufacturing Organizations (CDMOs). The role works closely with the CMC team and collaborates with colleagues in downstream processing, analytical development, drug product, Quality Assurance, regulatory affairs, and program management. This position contributes to CMC strategy and supports the development of biotherapeutics in an innovative and growing team environment.

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.

Join our dynamic team at Artech Information Systems LLC as a Scientist II, where your expertise will contribute to cutting-edge research and innovation. We are seeking a detail-oriented and motivated individual to engage in scientific projects that push the boundaries of technology and discovery.