Director of Biostatistics

We are in search of a highly skilled Director of Biostatistics to take on the role of Study Statistician across several drug development programs. This pivotal position will involve crafting statistical strategies from the early stages of development through to regulatory submissions, collaborating cross-functionally to facilitate data-driven decision-making…

Zenas is a pioneering biopharmaceutical company at the clinical stage, dedicated to leading the charge in developing and commercializing groundbreaking therapies for patients suffering from autoimmune diseases. Our strategic approach combines a highly experienced leadership team with a rigorous methodology for acquiring and developing product candidates worldwide, ensuring that we deliver exceptional clinical benefits to patients. We are currently advancing two late-stage candidates: obexelimab and orelabrutinib. Obexelimab is our flagship product, a bifunctional monoclonal antibody engineered to bind CD19 and FcγRIIb, prevalent across B cell lineages, to inhibit the activity of cells associated with various autoimmune diseases without causing depletion. We believe that the unique mechanism of action of obexelimab, along with its self-administered subcutaneous injection regimen, positions it to effectively combat the pathogenic role of B cells in chronic autoimmune disorders. On the other hand, orelabrutinib is a potentially best-in-class, highly selective oral Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to penetrate the CNS and address localized inflammation and disease progression in Multiple Sclerosis (MS). Additionally, Zenas is pursuing earlier stage programs, including a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor.We are in search of exceptional talent who share our unwavering commitment to improving patient outcomes and possess a proven track record in global product acquisition, development, and commercialization. Our team enjoys a dynamic and fast-paced learning environment, where individual and organizational success is paramount as we strive to establish ourselves as a global leader in immunology and autoimmune disease therapies. We embody our core values of Transparency, Relationships, Urgency, Excellence, and Innovation – TRUE Innovation!Position Summary:The Associate Director of Biostatistics will spearhead the development and execution of statistical methodologies for our global clinical programs. This role involves project leadership and providing technical statistical support. The position reports directly to the Senior Director of Biostatistics.Key Responsibilities:Lead the development and execution of all statistical components for one or more clinical development programs, including contributions to study design, analysis planning, presentation and interpretation of study results, authorship of clinical study reports, regulatory submissions, and publications.Review or author statistical analysis sections of protocols...

Zenas is at the forefront of biopharmaceutical innovation, dedicated to transforming the lives of patients with autoimmune diseases. Our strategy fuses the expertise of our seasoned leadership team with a meticulous process for sourcing and developing product candidates that promise enhanced clinical outcomes for those affected by these conditions. Currently, we are progressing two late-stage flagship molecules: obexelimab and orelabrutinib. Obexelimab, our lead candidate, is a bifunctional monoclonal antibody crafted to target both CD19 and FcγRIIb, effectively modulating B cell lineage activity linked to various autoimmune diseases, all while preserving cell integrity. We believe that the unique mechanism of obexelimab, combined with its self-administered subcutaneous delivery, positions it as a transformative solution for chronic autoimmune conditions. Orelabrutinib, on the other hand, is a promising, highly selective oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Additionally, our early-stage programs feature a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor, both demonstrating potential for best-in-class status.We are eager to attract exceptional talent who share our passion for patient care and possess a proven track record in global product acquisition, development, and commercialization. At Zenas, our colleagues thrive in a dynamic learning environment where both personal and organizational accomplishments flourish as we strive to establish ourselves as a leader in immunology and autoimmune disease treatment, driven by our core values of Transparency, Relationships, Urgency, Excellence, and true Innovation!Position Summary:The Head of Biostatistics will assume a pivotal leadership role within the Biostatistics function, spearheading statistical strategy and oversight for all clinical programs and studies. This individual will manage and mentor the biostatistics and statistical programming team, collaborating closely with cross-functional departments such as clinical development, clinical operations, clinical pharmacology, pharmacovigilance, regulatory affairs, and project management to ensure alignment of statistical elements with the overarching program strategy. Furthermore, the Head of Biostatistics will engage with regulatory bodies and oversee the preparation of statistical components for protocols, clinical study reports, and regulatory submissions.

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologic therapies for chronic skin diseases, with a focus on achieving complete disease clearance for patients with conditions like plaque psoriasis. The company’s antibody portfolio, created in partnership with Paragon Therapeutics, targets the underlying mechanisms of dermatologic and inflammatory diseases. Oruka’s goal is to offer patients long-lasting relief, potentially with just one or two treatments per year. Learn more at www.orukatx.com. Position Details Title: Director/Senior Medical Director, Clinical Development (Multiple openings) Location: Remote or hybrid. For those near Waltham, MA or Menlo Park, CA, hybrid work is available (3 days per week in office). Role Overview The Director or Senior Medical Director, Clinical Development, leads and supports clinical trials across Oruka’s pipeline. This role shapes clinical study design, oversees trial execution, and interprets data to validate product safety and efficacy. Collaboration with internal teams and external partners is central, ensuring clinical activities align with regulatory, scientific, and business goals. Main Responsibilities Clinical Trial Design and Oversight: Help develop clinical trial protocols, including patient selection, study endpoints, and data collection plans. Oversee the conduct of clinical trials at study sites, ensuring adherence to protocols and Good Clinical Practice (GCP) standards. Review and interpret trial data to evaluate the safety and efficacy of investigational products.

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.

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.

Role Overview Crescent Biopharma seeks a Director or Senior Director of Clinical Business Operations in Waltham, MA. This leader guides clinical operations strategy and oversees a team dedicated to the execution of clinical trials. The role involves close collaboration with multiple departments to keep projects on track and compliant with regulatory standards. Key Responsibilities Shape and refine clinical operations strategy Lead and mentor the clinical business operations team Work cross-functionally to support clinical trial execution Optimize processes and manage operational resources Maintain compliance with all relevant regulatory requirements

AbbVie is seeking a highly skilled and experienced Scientific Director or Medical Director to lead our Medical Affairs team specializing in Oncology, specifically focusing on Ovarian Solid Tumor. In this pivotal role, you will be responsible for driving strategic initiatives, providing medical insights, and collaborating with cross-functional teams to enhance patient outcomes through innovative therapies.

Role Overview Sobi is hiring a Director of HOVA to guide the strategic and operational direction of HOVA projects in Waltham. This leader will shape priorities, manage execution, and ensure projects support Sobi’s mission to improve healthcare outcomes. Key Responsibilities Oversee HOVA project strategy and daily operations Align initiatives with company goals and mission Promote collaboration across teams and departments Support growth and strengthen Sobi’s position in the market

Join Deciphera Pharmaceuticals as the Director of Legal Compliance, where you will play a pivotal role in ensuring the integrity and compliance of our legal operations. You will lead initiatives that uphold our commitment to ethical standards while navigating the complex regulatory landscape of the pharmaceutical industry.Your responsibilities will include developing and implementing compliance programs, conducting audits, and providing guidance on legal matters. You will work closely with various departments to promote a culture of compliance and minimize legal risks.

Xometry (NASDAQ: XMTR) is at the forefront of transforming the manufacturing landscape by linking visionary thinkers with the manufacturers capable of actualizing their concepts. Our digital marketplace equips manufacturers with essential tools for growth while simplifying the process for buyers from Fortune 1000 companies to access global manufacturing capabilities.We are currently looking for a Director of Category Management based in Boston or Maryland/DC/North Virginia to strategically enhance our CNC and Tooling division. You will play a pivotal role in defining the category's strategic direction, solving complex challenges, and executing tactical plans while overseeing crucial business metrics. As a Category Manager, exceptional negotiation skills and cross-functional project management abilities are vital.Xometry stands as a leading AI-driven marketplace for on-demand manufacturing, connecting clients with a nationwide network of qualified suppliers. Our platform optimizes custom parts production through cutting-edge technologies such as CNC machining, 3D printing, sheet metal fabrication, and injection molding. By utilizing proprietary pricing algorithms, real-time capacity insights, and extensive manufacturing knowledge, we provide faster lead times, competitive pricing, and scalable production solutions for diverse industries including aerospace, automotive, medical, and consumer products.

Crescent Biopharma is dedicated to transforming the oncology landscape by developing cutting-edge therapies for cancer patients. Our clinical-stage pipeline boasts innovative programs, including a PD-1 x VEGF bispecific antibody and advanced antibody-drug conjugates. By harnessing multiple therapeutic modalities and targeting established pathways, we strive to expedite the delivery of potentially groundbreaking treatments, whether as standalone therapies or in combination regimens aimed at various solid tumors. To learn more about our initiatives, visit www.crescentbiopharma.com and connect with us on LinkedIn and Twitter.

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.

Crescent Biopharma is on a mission to revolutionize oncology care by developing cutting-edge therapies for cancer patients. Our innovative clinical pipeline includes a leading PD-1 x VEGF bispecific antibody and a suite of novel antibody-drug conjugates. By harnessing diverse modalities and established targets, we aim to expedite the development of potentially transformative treatments, either as standalone therapies or in combination regimens, for various solid tumors. To learn more, visit www.crescentbiopharma.com and follow us on LinkedIn.

ElevateBio is a pioneering technology company dedicated to advancing the biotechnology landscape. We empower our partners to unlock the full potential of their therapies, guiding them from initial design through to successful commercialization. Our unique blend of innovative technologies, comprehensive services, and top-tier manufacturing expertise allows us to expedite the development of advanced therapies with remarkable efficiency.About ElevateBioAs a leader in the biotech industry, ElevateBio integrates cutting-edge technologies and unparalleled services to enhance the therapeutic development journey. Our mission is to transform the potential of therapies into reality, ensuring faster and more effective solutions for patients worldwide.The Role:We are in search of a dynamic and results-oriented Director of Commercial Excellence to spearhead the optimization of our comprehensive commercial operations. Reporting directly to the Chief Commercial Officer, this pivotal role is responsible for enhancing sales effectiveness, refining go-to-market strategies, and fostering alignment among sales, marketing, and cross-functional teams. The ideal candidate will possess strong analytical skills, operational leadership experience, and a fervent commitment to developing scalable processes, high-performing teams, and data-informed strategies.Key Responsibilities:Design and continuously refine the end-to-end sales process to boost efficiency and expedite the sales cycle, incorporating innovative solutions such as AI-driven proposal generation.Lead the strategy for our commercial technology stack, taking full ownership of the CRM system to ensure data integrity, user engagement, and system enhancements that align with sales and marketing goals.Transform raw CRM data into actionable insights, crafting informative dashboards and reports that track sales performance trends, enable accurate forecasting, and provide strategic recommendations to senior management.Develop and implement a comprehensive onboarding program for all new sales and commercial team members, instilling our company culture, values, and core sales methodologies from the outset.Establish and promote an ongoing learning initiative for the commercial team, providing regular training on new product features, evolving value propositions, competitive landscape, and best practices.Oversee the planning and execution of strategic Go-to-Market (GTM) initiatives, ensuring seamless collaboration between a well-equipped sales team, marketing, and product development to maximize market impact.

Xometry (NASDAQ: XMTR) is at the forefront of innovation, connecting visionary individuals with the manufacturers who can transform their concepts into reality. Our digital marketplace equips manufacturers with essential resources for growth while facilitating access to global manufacturing capabilities for Fortune 1000 companies.As the Director of Marketplace Marketing, you will play a pivotal role in shaping and executing go-to-market strategies for two vital segments of Xometry’s operations: enhancing growth within the U.S. Marketplace (Buyer-focused) and expanding our Global Partner network (Supplier-focused). This position requires a strategic thinker and hands-on leader who can set a compelling vision while actively participating in the execution of impactful marketing initiatives.Your role will center on grounding marketing activities in genuine market insights and maintaining a disciplined focus on return on investment (ROI). You will ensure that buyer acquisition strategies and partner engagement programs are informed by real-world feedback, optimized for measurable performance, and drive significant business results.

As the Director of Brand Leadership at Deciphera Pharmaceuticals, you will play a pivotal role in shaping the marketing strategies within our Hematology portfolio. Reporting directly to the VP of Marketing, Sales, and Commercial Training, you will spearhead a dynamic Marketing Team focused on crafting and executing innovative brand strategies.Key ResponsibilitiesFormulating a Comprehensive Strategic Brand Plan (50%)Collaborate with cross-functional teams to design an all-encompassing pre-launch and launch strategy.Create robust brand strategies and promotional plans targeting both healthcare professionals (HCPs) and patients across various platforms.Lead the Launch Readiness initiatives in a cross-functional capacity.Inspire and mobilize the entire commercial team and cross-functional partners to ensure alignment with our commercial strategy and to execute impactful customer outreach aligned with brand objectives.Manage the Product Marketing Team (40%)Ensure cohesive marketing strategies across all marketing colleagues to meet brand objectives effectively.Supervise one direct report to drive commercial success for the product while providing coaching and mentorship to develop our future talent in the Hematology Franchise.Serve as the Commercial Representative for Product Life Cycle Management (10%)Work in tandem with product program teams and Medical Affairs to contribute insights on studies, publications, and the identification and engagement of Key Opinion Leaders (KOLs).Additional duties and responsibilities as assigned

Who We Are:Cogent Biosciences is a pioneering biotechnology firm dedicated to creating innovative precision therapies aimed at addressing a wide array of unmet medical needs. Our flagship program, bezuclastinib, is engineered to selectively and effectively inhibit exon 17 mutations within the KIT receptor tyrosine kinase, including the KIT D816V mutation, which plays a critical role in a rare and severe condition known as Systemic Mastocytosis. Additionally, exon 17 mutations are prevalent in patients with gastrointestinal stromal tumors (GIST), a cancer type that significantly relies on oncogenic KIT signaling. Bezuclastinib has shown promising initial results across three clinical trials: APEX in AdvSM, SUMMIT in NonAdvSM, and PEAK in GIST, demonstrating an encouraging safety profile in over 600 patients with both single-agent and combination dosing.The Role: As Cogent Biosciences gears up for its inaugural commercial launch, we are in search of a proactive and driven Director of IT Business Partner to oversee Commercial, Medical Affairs, and Corporate Applications. In this strategic and hands-on role, you will work closely with cross-functional business leaders and teams to document and implement the technology roadmap for these sectors. You will be instrumental in supporting various existing and new system implementations in our dynamic environment.This position reports directly to the Vice President of Information Technology and is classified as a hybrid role; candidates should be located near our Waltham, MA office.

Role Overview ZoomInfo is seeking a Director of Financial Planning & Analysis to join our team in Bethesda, MD; Vancouver, WA; or Waltham, MA. This position is central to our transformation of finance into a strategic partner for the business. With automated planning frameworks and advanced AI systems handling routine work, this role centers on providing insights, anticipating challenges, and influencing decisions across the company. The Director of FP&A will develop financial systems, oversee budgeting and forecasting for Cost of Sales, G&A, R&D, and key GM business models, and build strong financial partnerships. This person will work closely with the Executive Leadership Team (ELT) and their counterparts, combining analytical skills with strategic thinking. The position reports to the Senior Vice President of Strategic Finance and manages one direct report. What You Will Do Lead the Annual Operating Plan (AOP) and monthly/quarterly forecasts for assigned functions, preparing detailed budgets and executive-level presentations. Serve as a trusted financial partner to functional leaders, proactively identifying risks, opportunities, and strategic implications to help prevent surprises. Conduct monthly business reviews with variance analyses and clear, actionable perspectives. Build dynamic financial models for headcount, operational expenditures, and unit economics. Support GM-level business modeling, including investment evaluations and scenario planning. Collaborate with Sales Finance, Corporate Finance, Accounting, Procurement, and HR to improve record-keeping and connect operational drivers to financial results. Develop systems and processes using agentic workflows and AI tools to automate repetitive tasks. Mentor one direct report, upholding high standards of rigor and collaboration. Act as a leader and culture ambassador within the FP&A team, working with peers to refine and improve processes. Reporting Structure This role reports to the Senior Vice President of Strategic Finance and supervises one direct report. Locations Bethesda, Maryland, United States Vancouver, Washington, United States Waltham, Massachusetts, United States

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics for chronic skin conditions, with a focus on achieving strong disease clearance through infrequent dosing, sometimes as little as once or twice per year. The company’s pipeline includes antibodies engineered by Paragon Therapeutics that target the underlying mechanisms of plaque psoriasis and other dermatological and inflammatory diseases. Learn more at www.orukatx.com. Role Overview Title: Director / Senior Director, Regulatory Affairs Strategy Location: Hybrid preferred (Menlo Park, CA or Waltham, MA). Remote considered. This position serves as Global Regulatory Lead for one or more development programs and reports directly to the Vice President of Regulatory Affairs. The Director/Senior Director will define and execute regulatory strategies to support the global advancement of Oruka’s biologics, with a focus on immunology and dermatology programs. What You Will Do Lead regulatory strategy for assigned programs, translating product goals into actionable development and registration plans. Drive key regulatory milestones and oversee major submissions. Represent Oruka in interactions with health authorities. Identify regulatory risks and opportunities in alignment with company objectives. Collaborate across functions to ensure high-quality, timely global development of the portfolio. What Sets This Role Apart This is a visible leadership role with influence over the regulatory direction of programs aiming for infrequent dosing, strong efficacy, and lasting results in psoriasis and related conditions. The position offers the chance to shape strategies for a pipeline of engineered antibodies intended to change how chronic skin diseases are treated.