Senior Medical Director, Clinical Development

Senior Medical Director, Clinical DevelopmentDren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies.The Senior Medical Director, Clinical Development will serve as a key clinical and scientific leader and provide input on autoimmune clinical studies, clinical development program strategy and life cycle management. He/she will work closely with cross-functional groups that include Research, Translational Sciences, Clinical Operations, Regulatory, Patient Safety, Medical Affairs, and Commercial to ensure that Clinical Development scientific and medical strategies are aligned with broader corporate and patient needs. He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.Role and Responsibilities:Provide key contributions to the development of a clinical development plan and lead the design and implementation of autoimmune clinical studiesServe as the clinical lead and medical monitor for one or more clinical studyContribute to and support the development of protocols, investigator brochures, clinical study reports and review clinical trial documentsProvide clinical leadership and medical strategic input for all clinical deliverables: clinical sections of individual protocols, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publicationsReview and interpret safety data on an ongoing basis to ensure overall safety of the molecule for the assigned section, and supports overall program safety reporting, and other safety related documents in collaboration with pharmacovigilance function)Conduct investigator meetings and lead site initiation visits with clinical trial investigatorsTranslate findings from research and nonclinical studies into clinical development opportunitiesInteract with clinical investigators and thought leadersProvide clinical leadership and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)Provide strategic support and work closely with company leadership on strategic and corporate initiativesProvide medical support as needed on company and non-company sponsored studies, non-interventional studies and investigator sponsored studiesPerform other duties as requiredEducation, Experience and Qualification Requirements:M.D. degree with specialization in Immunodermatology preferred and a minimum of 4 years in industry, or relevant drug development experience in the management and execution of phase I-III trialsExperience as medical monitor of early-stage autoimmune clinical trialsWillingness to travel up to 25% of the timePermitted to work in the United StatesCore Competencies, Knowledge and Skill Requirements:Proven clinical drug developer with experience designing and implementing and conducting clinical trials. Experience with early-stage clinical trials preferredKnowledge of carrying out autoimmune clinical trials, including knowledge of competitive and regulatory landscape.Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals of DrenDemonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigatorsDemonstrated ability to work well in teams in a cross functional mannerAbility to communicate and work independently with scientific/technical personnelAbility to think critically, and demonstrated troubleshooting and problem solving skillsSelf-motivated and willing to accept temporary responsibilities outside of initial job descriptionComfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing prioritiesExcellent written and oral communication skills, including presentation skillsFamiliarity with US and international regulatory frameworks (CFR21, ICH, GCP, etc.)Possess an understanding of applicable US and EU drug development regulations and GCP regulationsMay travel up to 25%Salaries, Benefits and Other Employee Perks:Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company's total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $275,000 and $300,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio's Human Resources department can share more about the specific pay range based on the market location of the candidate.Employment Practices:Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.Interested Applicants:Please send resume and cover letter to View email address on click.appcast.io