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Sr. Medical Director

Contineum Therapeutics
locationSan Diego, CA, USA
PublishedPublished: 6/14/2022
Healthcare
Full Time

Job Description

Job Title: Senior Medical Director

Reports to: Tim Watkins, CMO, Head of Development

Department: Clinical

Schedule: Hybrid and/or Remote

People Manager: Yes

FLSA Status: Exempt

Location: San Diego, CA or Remote


Company Overview:

Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel, oral small-molecule therapies for neuroscience, inflammation, and immunology (NI&I) indications with high unmet needs. We target biological pathways associated with specific clinical disabilities, aiming to impact the course of disease. In addition to multiple indications within neuroscience, our pipeline includes programs for idiopathic pulmonary fibrosis (IPF), as well as other inflammatory and fibrotic disorders.


Job Summary

The Senior Medical Director reports to the Chief Medical Officer, Head of Development, and will primarily play a leadership role in clinical development efforts for idiopathic pulmonary fibrosis, with potential support for other inflammatory and neuroinflammatory diseases at Contineum Therapeutics. You will join a clinical development team with active Phase 2 programs underway and in development, with potential for work across earlier phases, as well. You will provide scientific and clinical leadership on activities including clinical development plan generation; clinical study planning, conduct, and read-out; scientific communication; regulatory filings; and efforts to advance value proposition for therapeutic agents meeting important unmet medical needs. The ideal candidate will have a strong scientific acumen; desire to work in fast-paced, matrixed environment; drive to expand your skillset as needed to meet team goals; ability to lead both strategic work as well as having high attention to detail; and track record of working collaboratively to achieve team goals.



Key Responsibilities:

· Lead or oversee clinical trial protocol design, analysis planning, clinical study report development, and response to health authority inquiries

· Provide scientific and clinical leadership or oversight in the preparation, review, and interpretation of clinical study data, ensuring high quality data

· Oversee or perform clinical study medical monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data review as part of a cross-functional team

· Provide leadership, technical insights, and clinical/medical perspective into ongoing and planned research and development strategy; including development of the target product profile and clinical development plan for assigned molecules /products

· Contribute to global regulatory strategies and lead clinical development contributions in the preparation and review of regulatory documents

· Provide scientific and clinical leadership or oversight in the preparation of DSURs and investigator brochures

· Serve as a medical representative of the company both internally and externally (scientific community and key experts)

· Provide medical review, assessment, and interpretation of all clinical data to ensure that the data is presented with the appropriate medical interpretation

· Responsible for medical monitoring of human clinical trials for company products under development, including determination/confirmation of subject eligibility

· Responsible for medical review of adverse event reporting and safety monitoring.

· Contribute to the Identification and selection of appropriate clinical investigators to perform studies

· Cultivate relationships with global Key Opinion Leaders in academic and clinical medicine

· Maintain an understanding of competitors and disease-specific clinical developments

· Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Contineum Therapeutic’s standards


Minimum Requirements:

· Candidate must have an MD or equivalent and a minimum of 5 years of clinical, scientific, and/or drug development experience in the biopharmaceutical industry, biotechnology industry, and/or clinical research at a leading academic institution

· Advanced training in pulmonary medicine, or related fields, is preferred; other backgrounds, including rheumatology, hepatology, or other internal medicine backgrounds with experience in clinical research in chronic pulmonary diseases, inflammation/fibrosis, IPF/ILD, and/or autoimmunity also considered

· An outstanding track record of achievement in the clinical development of therapeutic products, particularly in pulmonology

· Experience in designing and implementing all phases of clinical studies, particularly early studies through Phase 2

· A proven ability to perform in-depth research, analysis, and interpretation of medical data

· Thorough knowledge of FDA requirements and regulatory strategies

· A proven ability to assemble evaluated information into an accurate, comprehensive, and concise standard medical response document or dossier

· Excellent verbal and written communication, presentation, and customer service skills

· An ability to embrace the importance of teamwork and show strong interpersonal skills and accountability

· Must have demonstrated ability to be flexible and multitask in fast-paced, high-pressure, changing conditions

· Strong oral and written communication skills

· Organized and self-motivated

· Collaborative work style with strong interpersonal skills

· Strong desire to develop new expertise and learn new skills in new areas to accomplish team goals

and advance professional development within the biopharma industry

  • Ability to travel when needed


Compensation and Benefits: We offer a competitive total compensation package, as well as working in a supportive team environment.


  • The anticipated salary range for candidates who will work in San Diego, CA, is $305,000-$350,000. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc.


Contineum offers competitive compensation and benefits, including:

  • · 90% employer-covered benefits
  • · Flexible PTO
  • · A very generous holiday schedule that includes a week off in August and time off around the winter holidays
  • · A well-stocked kitchen with snacks and beverages
  • · Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.
  • · The comprehensive wellness program includes medical, dental, vision, and LTD coverage.


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