Director of Commercial Excellence

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…

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 us at Xometry as a Senior Analyst in Operational Excellence, where you will play a pivotal role in enhancing our operational processes. You will collaborate with cross-functional teams to identify areas for improvement, implement best practices, and drive continuous improvement initiatives. Your analytical skills will be crucial in interpreting data and providing actionable insights that will help optimize our operations and contribute to the overall success of the company.

Xometry (NASDAQ: XMTR) is at the forefront of innovation, bridging the gap between visionary thinkers and manufacturers capable of transforming ideas into reality. Our cutting-edge digital marketplace equips manufacturers with essential tools to expand their operations, while facilitating seamless access to global manufacturing capabilities for Fortune 1000 companies.We are currently in search of a dynamic and results-oriented Senior Operational Excellence Manager to become an integral part of our expanding team. This role is tailored for an analytical strategist and proactive executor, adept at scrutinizing operational and customer service data, pinpointing inefficiencies and performance gaps, and converting insights into tangible enhancements. In collaboration with cross-functional teams including Customer & Partner Support and Partner Network Management, you will spearhead scalable process improvements and establish standards that boost efficiency, elevate customer and partner satisfaction, and enhance financial outcomes.

The Medical Excellence Manager will play a pivotal role in overseeing Investigator Sponsored Studies (ISS), Managed Access Programs (MAP), and Post Trial Access (PTA) Programs. The successful candidate will be tasked with:Managing the ISS review and approval process, ensuring thorough proposal validation, coordination of reviews, and effective communication of decisions to stakeholders.Oversight of the MAP/PTA review and approval process, which includes coordinating case reviews, documenting decisions, and engaging with relevant parties.Acting as the global point of contact for ISS and MAP management concerning specified products, collaborating with cross-functional internal and external stakeholders.Maintaining detailed databases for ISS and MAP/PTA, meticulously tracking proposals, studies, and decisions along with necessary documentation.Facilitating contract development and negotiations between sponsors/requestors and Sobi, working closely with legal and other departments as necessary.Supporting supply chain setup in partnership with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs.Providing regular status updates on ISS and MAP/PTA programs to relevant teams and leadership.Monitoring milestone payments and reporting the ISS budget to budget owners.Coordinating with vendors for the setup and management of MAP and PTA programs as needed.

Join ServiceNow as a Senior Solution Consultant specializing in Commercial Growth. In this pivotal role, you will leverage your expertise to drive innovative solutions that enhance our clients' business processes. Collaborate with cross-functional teams to develop strategies that align with customer needs, ensuring the delivery of exceptional value and service.

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.

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.

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 while upholding scientific and regulatory standards.Key ResponsibilitiesDevelop and oversee statistical strategies for various clinical studies throughout all phases of development.Contribute to Clinical Development Plans and represent Biostatistics in cross-functional teams.Design clinical studies, author and review protocols and Statistical Analysis Plans (SAPs), and supervise interim and final analyses.Ensure the quality, accuracy, and reproducibility of statistical outputs in partnership with programming teams and CROs.Assist with regulatory submissions (including INDs, NDAs, BLAs, MAAs), including interactions with health authorities and integrated summaries (ISS/ISE).Oversee external vendors and mentor junior statisticians or contractors.Contribute to scholarly publications, conference presentations, and continuous improvement initiatives.

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.

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.