Medical Director of Pharmacovigilance

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 pharmacovigilan…

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.

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.

Sobi is seeking a Senior Medical Director of Rheumatology to join the Medical Affairs team in Waltham. This role centers on setting direction for rheumatology initiatives and collaborating with leading experts in the field. Key responsibilities Shape the medical strategy for rheumatology within Medical Affairs Guide research efforts to support new and ongoing projects Work closely with top professionals in rheumatology to advance patient care Impact The Senior Medical Director will play a central role in improving patient outcomes and supporting the development of new treatments in rheumatology. Location This position is based in Waltham.

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 OverviewWe are on the lookout for a highly motivated and strategic Medical Director, Clinical Development to spearhead our clinical development initiatives across various early- and late-stage programs. This essential position presents a unique opportunity to influence clinical strategy, act as a medical monitor, and work collaboratively across departments to ensure successful execution. The role also involves mentoring clinical scientists and contributing to business development and process enhancements as per organizational needs.Primary ResponsibilitiesLeadership in Clinical Development (75%)Direct clinical strategy and oversee execution for multiple programs; serve as the medical monitor while managing study-level activities.Collaborate with clinical science and safety teams to conduct data reviews; author clinical and regulatory documents, including protocols, Investigator's Brochures (IBs), and Investigational New Drug applications (INDs).Engage with Key Opinion Leaders (KOLs), facilitate advisory boards and steering committees, and support scientific publications.Present findings to executive leadership and contribute to the scientific and commercial progress of our pipeline assets.Cross-Functional Collaboration & Organizational Contribution (25%)Work collaboratively across functions to ensure alignment, effective communication, and operational excellence across teams, as well as between Ono and Deciphera.Provide clinical insights for target assessments, business development activities, and strategic initiatives.Support Medical Affairs and act as a clinical liaison for study sites and internal stakeholders.Take part in continuous improvement initiatives and promote a culture of collaboration within the company.

Deciphera Pharmaceuticals is seeking a highly skilled and experienced Senior Medical Director of Clinical Development to lead our clinical research initiatives. In this pivotal role, you will oversee the design and execution of clinical trials and collaborate closely with cross-functional teams to advance our innovative therapies. The ideal candidate will have a deep understanding of clinical development processes and a proven track record in leading successful trials.

Zenas is a pioneering clinical-stage global biopharmaceutical firm devoted to leading the way in the development and commercialization of groundbreaking therapies for patients suffering from autoimmune diseases. Our strategic approach integrates our seasoned leadership with a meticulous product acquisition strategy to identify, acquire, and develop product candidates worldwide that can deliver exceptional clinical benefits to those affected by autoimmune conditions. Currently, Zenas is propelling two advanced-stage potential franchise products, obexelimab and orelabrutinib. Obexelimab, our flagship candidate, is a bifunctional monoclonal antibody engineered to bind to both CD19 and FcγRIIb—markers prevalent across B cell lineages—to modulate the activity of cells involved in various autoimmune disorders without causing depletion. We believe that obexelimab's innovative mechanism of action and its self-administered subcutaneous injection regimen can effectively target the pathogenic roles of B cell lineages in chronic autoimmune diseases. Orelabrutinib is an orally administered, highly selective CNS-penetrant Bruton’s Tyrosine Kinase (BTK) inhibitor that may address localized inflammation and disease progression in Multiple Sclerosis (MS). Additionally, Zenas is advancing early-stage programs, including a preclinical oral IL-17AA/AF inhibitor and a preclinical oral brain-penetrant TYK2 inhibitor.We are on the lookout for 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. Our team members have the opportunity to thrive in a dynamic learning environment, contributing to both personal and organizational success as we strive to become a global leader in immunology and autoimmune diseases, all while embodying our core values of Transparency, Relationships, Urgency, Excellence, and Innovation—what we call TRUE Innovation!Position Summary: The Medical Director, Clinical Development in Neurology will play a pivotal role in the development and execution of essential initiatives within the Neurology Therapeutic Area in our Clinical Development department. This team is responsible for overseeing Phase I-III clinical research and providing the company with vital medical and scientific expertise related to the therapeutic area. The Director will act as a key resource for the VP of Clinical Development in Neurology and serve as a medical authority concerning products advancing through various phases of drug development.

About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologic therapies aimed at redefining the treatment landscape for chronic skin diseases. Our mission is to empower patients battling chronic conditions such as plaque psoriasis by providing unprecedented freedom from their ailments, achieved through infrequent dosing schedules of merely once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies, engineered by Paragon Therapeutics, that target the fundamental mechanisms behind plaque psoriasis and other dermatologic and inflammatory conditions. To learn more, please visit www.orukatx.com.As we continue to expand our core team, we are in search of exceptional talent across various functional areas. We want individuals who are not merely seeking employment but are eager to be part of a transformative journey. If you are passionate about making a meaningful impact and are excited to contribute to a vibrant, inclusive, and positive company culture, we encourage you to apply.Job Title: Executive Medical Director, Clinical DevelopmentLocation: Remote or Hybrid (3 days/week on-site if located near our offices in Waltham, MA or Menlo Park, CA).Role Overview: The Executive Medical Director of Clinical Development plays a pivotal role in steering the design, execution, and oversight of clinical trials at the asset level, ensuring the generation of high-quality data to support the safety and efficacy of our pipeline products. This position involves leading and cultivating a team, as well as shaping and influencing clinical development strategies across assets, including study design, implementation, and data interpretation. The Executive Medical Director will collaborate closely with internal and external stakeholders to ensure that trial execution aligns with regulatory, scientific, and business objectives in a fast-paced environment. This role reports directly to the Vice President of Clinical Development.Key Responsibilities: Strategic Leadership:Drives the clinical development strategy for one or more assets.Identifies critical clinical milestones and ensures alignment with overall organizational goals.

Crescent Biopharma is on a mission to establish itself as a leading force in oncology, dedicated to innovating the next generation of cancer therapies. Our clinical-stage pipeline features groundbreaking initiatives, including a PD-1 x VEGF bispecific antibody and advanced antibody-drug conjugates. By integrating diverse modalities and targeting established pathways, Crescent is poised to accelerate the development of transformative treatments, either as standalone options or in combination therapies, aimed at addressing various solid tumors.For further details, visit our website at www.crescentbiopharma.com and connect with us on LinkedIn.

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.

Zenas Bio is an innovative clinical-stage biopharmaceutical company focused on transforming the treatment landscape for patients with autoimmune diseases. Our strategic approach blends a seasoned leadership team with a meticulous product acquisition strategy, enabling us to identify, acquire, and develop promising therapies that deliver exceptional clinical benefits. Currently, we are progressing two late-stage molecules: obexelimab and orelabrutinib. Obexelimab is our flagship candidate, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to modulate B cell activity in autoimmune diseases without cell depletion. Orelabrutinib is a highly selective, oral Bruton’s Tyrosine Kinase (BTK) inhibitor designed to penetrate the central nervous system and address inflammation in Multiple Sclerosis. Additionally, we are advancing a pipeline that includes a preclinical IL-17AA/AF inhibitor and a TYK2 inhibitor. We invite passionate individuals to join our mission of elevating patient care through groundbreaking research and innovation. At Zenas Bio, you will thrive in a dynamic environment that values Transparency, Relationships, Urgency, Excellence, and Innovation—our core values of TRUE Innovation!Territory: US - EastPosition Summary:The Associate Director, Medical Science Liaison (MSL) for Neurology will serve as a vital field-based extension of our Medical Affairs team. MSLs are highly trained professionals with robust clinical and scientific expertise, dedicated to providing fair and balanced information to the healthcare community. This role reports directly to the Director of MSLs in Neurology.Key Responsibilities:Forge and sustain professional relationships with key opinion leaders and healthcare professionals at international, national, regional, and local levels.

Join Deciphera Pharmaceuticals as a Medical Science Liaison II, where you will play a pivotal role in bridging the gap between our innovative research and the medical community. Your expertise will help communicate the value of our products and support healthcare professionals in enhancing patient care.In this role, you will engage with healthcare providers, deliver scientific presentations, and provide educational support, all while collaborating with cross-functional teams to ensure alignment with our strategic objectives.

Join our dynamic team as a Medical Office Assistant where you'll play a crucial role in ensuring smooth operations within our healthcare practice. You will be responsible for a variety of administrative tasks including scheduling appointments, managing patient records, and assisting with billing inquiries. Your organizational skills and attention to detail will be vital in providing exceptional service to our patients.

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.

Explore exciting career opportunities in the clinical and medical support sectors at New England Donor Services. We are dedicated to enhancing organ donation and transplantation efforts, and we seek passionate individuals to join our team. As a leader in organ operations, you will play a crucial role in supporting our mission to save lives.

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.