Director of Legal Compliance

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 d…

Deciphera Pharmaceuticals, Inc. is on the hunt for an accomplished Senior Director of Legal Counsel to join our dynamic team in Waltham, MA. In this pivotal role, you will provide strategic legal guidance in drafting, negotiating, and interpreting both general and complex corporate agreements across various functions such as Research & Discovery, Commercial, Licensing and Distribution, Supply Chain, Tech Ops, Clinical, IT, and Facilities. You will lead the Contracts Team and collaborate closely with the General Counsel on a range of high-impact legal projects and initiatives.We are looking for a proactive and collaborative attorney specializing in life sciences, eager to contribute to the growth of our fast-paced global organization. This position requires effective collaboration with our European colleagues and our Japanese parent company, making cross-cultural communication skills essential for managing strategic initiatives across multiple countries and affiliates.Key Responsibilities:Contracting Oversight and Negotiation (50%):Lead, mentor, and develop a skilled Contracts Team while supporting their professional growth.Act as a primary legal advisor to business teams, overseeing the negotiation of routine and complex contracts within diverse, cross-functional teams.Serve as the principal negotiator for critical and sophisticated agreements.Drive Contracting Best Practices (20%):Establish, maintain, and optimize efficient contract operations and drive continuous improvement.Foster collaborative relationships with stakeholders and the Contracts Team to effectively address challenges and seize opportunities.Legal Strategy and Leadership (30%):Provide comprehensive legal support across the organization, addressing various matters including development strategy, regulatory activities, and HR processes while identifying complex legal and compliance issues.Proactively manage cross-border communication regarding legal operations and strategic projects, building collaborative relationships with Japanese counterparts.Encourage a positive team culture aligned with Deciphera’s core values of PATHS.Manage additional legal projects and responsibilities as required.Other duties and responsibilities as assigned.

The Director of Product Counsel within the Legal and Compliance department acts as a crucial strategic ally, delivering insightful and practical legal guidance to the Commercial, Medical Affairs, Market Access, and Patient Support teams for assigned products. This position is designed for a subject matter expert in U.S. healthcare laws, FDA promotional regulations, and industry codes. The Director ensures compliance and readiness for product launches while supporting ongoing commercialization and medical activities. Partnering closely with the Compliance team, this role aims to maintain a robust U.S. compliance program that aligns with the company’s core values, providing advisory services, training, and policy development to cross-functional teams.Key ResponsibilitiesCommercial & Medical Affairs Legal Support (75%)Act as the primary legal partner and subject matter expert for commercial and medical teams on established and forthcoming products.Offer pragmatic legal advice on launch strategies, disease awareness initiatives, marketing campaigns, patient programs, advisory boards, and other business activities related to assigned products.Serve as the Legal representative on various committees including the Promotional Review Committee and Medical Review Committee for established and launching products.Advise market access teams on pricing, reimbursement, distribution, and contracting structures; counsel on payer engagement matters including PIE and FDAMA 114; draft and oversee the development of market access and patient support agreements; provide legal guidance to patient support teams concerning hub services.Compliance Program Support (15%)Consult with commercial, medical, and advocacy teams regarding compliance obligations.Collaborate with the Compliance team to evolve the U.S. compliance program to ensure it remains appropriately sized and in alignment with company values.Design and deliver training on compliance responsibilities, ethics, policies, and procedures.Assist in the development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes.Cross-Functional Legal Support (10%)Facilitate legal support as a collaborative partner with business and Legal and Compliance colleagues.Other duties as assigned.

Join our dynamic legal team as a Contracts Administrator / Legal Associate, where your expertise will play a vital role in ensuring compliance and managing contracts effectively. You will work closely with various departments to facilitate contract review, negotiation, and execution while maintaining the highest standards of accuracy and efficiency.

Join Sobi as a Senior Manager of Ethics and Compliance in Waltham, MA, where you will play a pivotal role in enhancing our ethical standards and compliance protocols. You will lead initiatives to ensure our operations align with legal regulations and internal policies, fostering a culture of integrity and accountability. This is an exciting opportunity to influence and shape compliance practices within a dynamic organization.

Deciphera Pharmaceuticals, Inc. is on the lookout for a Senior Manager of Cybersecurity and Compliance to spearhead the development, implementation, and ongoing management of our cybersecurity, risk management, and compliance initiatives. This pivotal role will protect our global IT infrastructure, cloud environments, and SaaS applications while ensuring adherence to regulatory and industry standards in both the U.S. and Europe.In this leadership position, you will collaborate closely with IT, Quality, Legal, Privacy, and various business stakeholders to enhance our security posture, manage enterprise risks, and guarantee audit preparedness. Additionally, you will play a significant role in supporting global system integration efforts with our parent company in Japan.Key Responsibilities:Direct the cybersecurity strategy, governance, and enterprise security programs across infrastructure, cloud, and SaaS environments.Ensure compliance with essential regulatory and industry standards such as SOX, FDA, GxP, HIPAA, GDPR, NIST, and ISO 27001, and support internal and external audits.Oversee enterprise risk management, incident response planning, vulnerability management, and security operations collaborating with infrastructure teams.Manage security assessments and ongoing monitoring of third-party and SaaS vendors.Develop and maintain robust business continuity and disaster recovery (BC/DR) strategies.Foster a culture of security awareness, reporting, and continuous enhancement of cybersecurity maturity across the organization.

About Us:At Oruka Therapeutics (Nasdaq: ORKA), we are pioneering innovative biologics aimed at transforming the treatment landscape for chronic skin disorders. Our mission is to empower individuals battling chronic skin conditions, such as plaque psoriasis, by providing them with the utmost freedom from their ailments, achieving significant disease clearance through infrequent dosing, potentially just once or twice yearly. Our proprietary collection of antibodies, meticulously crafted by Paragon Therapeutics, targets the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory conditions. To learn more, visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas—individuals who seek more than just employment, but rather a chance to be part of something transformative. We value passion for making a difference and contributions to fostering an engaged, inclusive, and positive workplace culture.Job Title: Director of Clinical Quality AssuranceLocation: Remote; candidates located in the Waltham, MA area are preferred.Role Overview:The Director of Clinical Quality Assurance will provide strategic leadership and oversight for Oruka's clinical development initiatives, focusing primarily on Good Clinical Practice (GCP) and associated quality systems that support clinical trials. This role will establish, enhance, and oversee clinical quality processes appropriate to each phase, ensuring comprehensive supervision of clinical trial execution and vendor performance while preparing for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.This position will collaborate closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure compliance with GCP, relevant global regulations, internal procedures, and protocol requirements throughout the clinical trial lifecycle. The Director of Clinical QA will proactively contribute quality insights, support continuous improvement initiatives, and help cultivate a quality-centric culture as the organization progresses with its pipeline.Key Responsibilities:Clinical Quality Oversight: Ensure compliance with GCP and applicable regulatory requirements for new and ongoing clinical studies.

Location: Waltham, MA (hybrid) ERGO NEXT is dedicated to empowering entrepreneurs to succeed. We achieve this by offering the only technology-driven, full-stack provider of small business insurance in the industry, revolutionizing the entire value chain and enhancing the customer experience. In essence, wherever small businesses flourish, ERGO NEXT is present. Since our inception in 2016, we have aided hundreds of thousands of small business clients across the United States in obtaining swift, tailored, and affordable coverage. With backing from industry pioneers in both insurance and technology, we are poised for further growth — and that’s where you come in. The Senior Manager of Employee Relations & HR Compliance will spearhead our global employee relations and human resources compliance programs, ensuring a consistent, equitable, and legally compliant methodology. This role uniquely combines strategic employee relations leadership with extensive compliance knowledge—offering guidance, structure, and proactive risk management throughout the organization. This position will report directly to the Head of Global Center of Excellence and will collaborate closely with Legal, People Operations, HR Business Partners, and business leadership.

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 the dynamic team at Buyers Edge Platform as a Corporate Counsel, where you will play a pivotal role in providing legal guidance and support across various business functions. In this position, you will leverage your legal expertise to navigate complex legal issues, ensuring compliance with regulations while enabling strategic business initiatives.

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.