Senior Medical Director, 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 lead the 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 clinical deliverables: clinical sections of individual protocols, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, 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 trial investigators
• Translate findings from research and nonclinical studies into clinical development opportunities
• Interact with clinical investigators and thought leaders
• Provide 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 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 4 years in industry, or relevant drug development experience in the management and execution 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 and conducting clinical trials. Experience with early-stage clinical trials preferred
• Knowledge 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 Dren
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
• 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 solving skills
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Comfortable in a fast-paced company environment with minimal direction and able to adjust 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 GCP regulations
• May travel up to 25%

Benefits

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.

Pay

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.