Senior Medical Director, Clinical Development

BioSpace; San Carlos (CA); Hybrid; USD 275,000 - 300,000; Full time

Benefits offered by this job

Equity incentives

Total rewards program

Benefits package

Job summary

Dren Bio in the United States seeks a Senior Medical Director, Clinical Development to lead autoimmune clinical strategies and lifecycle plans. You will work with Research, Regulatory, Medical Affairs, Safety, and Commercial teams to ensure alignment with corporate goals.

The role requires an MD with Immunodermatology focus, 4+ years in industry, and willingness to travel up to 25%. Base pay ranges from $275,000 to $300,000 annually, with equity incentives and a comprehensive benefits package.

Qualifications

• MD degree with specialization in Immunodermatology preferred.
• Minimum 4 years in industry or relevant drug development experience in phase I-III trials.
• Experience as medical monitor of early-stage autoimmune clinical trials.

Responsibilities

• Provide clinical leadership for autoimmune clinical studies and develop clinical development plans.
• Serve as clinical lead and medical monitor for one or more autoimmune studies.
• Develop protocols, investigator brochures, and regulatory documents.
• Review safety data and support program safety reporting in collaboration with pharmacovigilance.

Skills

Clinical drug development

Regulatory knowledge

Leadership

Cross-functional collaboration

Medical monitoring

Education

MD degree with Immunodermatology focus

Minimum 4 years in industry or relevant drug development experience

Tools

ICH/GCP knowledge

Job description

About The Company

Dren 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. For more information, please visit our website at www.drenbio.com.

About The Company

Dren 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. For more information, please visit our website at www.drenbio.com.

Function

Clinical

Level

Senior Medical Director

Location

San Carlos, CA or Remote

Reporting Manager

SVP, Head of Clinical Development

About The Opportunity

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 leadthe design and implementation of autoimmune clinical studies
• Serve as the clinical lead and medical monitor for one or more clinical study
• Contribute to and support the development of protocols, investigator brochures,clinical study reports and review clinical trial documents
• Provide clinical leadership and medical strategic input for all clinicaldeliverables: clinical sections of individual protocols, clinical data review,program specific standards, clinical components of regulatory documents/registrationdossiers, and publications
• Review 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 trialinvestigators
• Translate findings from research and nonclinical studies into clinical developmentopportunities
• Interact with clinical investigators and thought leaders
• Provide clinical leadership and work in a team environment in interactions withexternal 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 andcorporate initiatives
• Provide medical support as needed on company and non-company sponsored studies,non-interventional studies and investigator sponsored studies
• Perform other duties as required

Education, Experience And Qualification Requirements

• M.D. degree with specialization in Immunodermatology preferred and a minimum of 4years in industry, or relevant drug development experience in the management andexecution of phase I-III trials
• Experience as medical monitor of early-stage autoimmune clinical trials
• Willingness to travel up to 25% of the time
• Permitted to work in the United States

Core Competencies, Knowledge And Skill Requirements

• Proven clinical drug developer with experience designing and implementing andconducting clinical trials. Experience with early-stage clinical trials preferred
• Knowledge of carrying out autoimmmune clinical trials, including knowledge ofcompetitive and regulatory landscape.
• Strategic leadership and tactical skills, excellent initiative and judgment, anddemonstrated ability to positively represent the goals of Dren
• Demonstrated ability to develop and maintain excellent working relationships withboth internal colleagues and external contacts, including key thought leaders, andinvestigators
• Demonstrated ability to work well in teams in a cross functional manner
• Ability to communicate and work independently with scientific/technical personnel
• Ability to think critically, and demonstrated troubleshooting and problem solvingskills
• Self-motivated and willing to accept temporary responsibilities outside of initialjob description
• Comfortable in a fast-paced company environment with minimal direction and able toadjust workload based upon changing priorities
• Excellent written and oral communication skills, including presentation skills
• Familiarity with US and international regulatory frameworks (CFR21, ICH, GCP, etc.)
• Possess an understanding of applicable US and EU drug development regulations and GCPregulations
• May 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.