Senior Medical Director

Location
Menlo Park, CA
Posted
Jun 05, 2021
Ref
CS-1007
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

AN2 Therapeutics, Inc. (AN2) is a biopharmaceutical company focused on developing novel anti-infective medicines for patients with rare, chronic infectious diseases – including global and neglected tropical diseases – that have significant unmet medical needs for new therapies. Founded by a team of experienced industry leaders in infectious diseases drug research and development, we strive to provide patients with treatments that will restore their health and enable them to live productive lives. AN2 is a mission-driven company with a passion for improving global public health and a vision to accelerate development of novel medicines to treat serious infectious diseases and save lives worldwide. We believe our company thrives when all employees share this mission.

AN2 is seeking an experienced Senior Medical Director to lead the creative, operational, and strategic functions associated with the clinical development process of novel antimicrobial drugs. This position will report to the Chief Medical Officer.

This individual will work with the Chief Medical Officer to create the clinical development plans and supporting protocols for Phase 1 – 4 clinical trials of novel anti-infective drugs. In addition, the Senior Medical Director will be responsible for working with the Clinical Operations team in the conduct of Phase 1 – 4 trials as the Sponsor (AN2) Medical Monitor.

 

Responsibilities:

  • Serve as the subject matter expert for lead drug product and its competitive landscape.

  • Work with the CMO, Clinical Sciences and Development Operations function, Clinical Microbiology, and Regulatory Affairs departments to formulate clinical regulatory strategies and ensure successful execution of clinical studies.

  • Develop and present clinical development plans and study protocols that support the clinical regulatory strategy.

  • Serve as the Medical Monitor of AN2-sponsored clinical trials.

  • Serve as medical liaison to investigators, study sites, and study team members, and represent the clinical department as a member of cross-functional project teams.

  • Create and conduct medical training for internal and external study personnel to support ongoing studies and investigator meeting materials.

  • Provide assistance to the Clinical Operations team in the administration of clinical trials and in the completion of study reports.

  • Analyze and interpret clinical data and present clinical summaries and updates to investigators, advisors, and advisory boards.

  • Provide a medical perspective to the development of target product profiles (TPPs).

  • Review and summarize relevant medical literature, as it relates to assigned projects.

  • Assist with conceptualization, writing, and review of publications (e.g., abstracts, posters, manuscripts) to support the product publication plan, and lead effort as appropriate.

  • Organize and participate in advisory board meetings, including development of meeting materials and interaction with external advisors to support ongoing programs.

  • Contribute to medical and commercial development of product candidates (both internal and external), including medical and scientific input for due-diligence processes and presentation of key findings.

  • Provide clinical advice and strategic input for external grant proposals and funding collaborations.

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    Qualifications and Experience:

  • An MD or MD/PhD with board certification in internal medicine or qualified medical expertise with an understanding of good clinical practices and ICH guidelines as well as drug development and regulatory processes through Phases 1 – 4.

  • Board certification in Infectious Diseases or Pulmonology a plus.

  • At least 5 years of experience in the pharmaceutical industry in clinical development preferred.

  • Experience with late-stage (Phase 2 – 4) studies from start-up activities to finalization of clinical study reports and other regulatory documents recommended.

  • Excellent written, verbal, and presentation skills required; proven track record of publication and scientific presentation experience preferred.

  • Strategic leader and problem solver with a strong ability to influence and drive a development team.

  • Proficiency with MS Word, Excel, Outlook, and PowerPoint.

  • Occasional travel will be required. Remote working is an option.

  • Current US work authorization required.

  • By joining our small, highly-dedicated and motivated team, you will experience a culture that is inclusive, supportive, and humble, yet challenging. We set our egos aside to collaborate for the benefit of the team, and most importantly, the patients in need of new therapeutic options. AN2 is a company with a passion for improving global public health. We approach our business using a double bottom line strategy – with the intention of a fiscal and social return - this is reflected in our Core Values and is the foundation of our company’s culture. We employ the industry’s best to create a corporate culture that is fun, humble, respectful, and fulfilling, and where employees feel that they are making a difference and feel inspired to bring their passion to work.

    We are an equal opportunity employer that values diversity, equity, and inclusion. We consider all qualified applicants regardless of race, sex, gender identity or expression, sexual orientation, age, religion, national origin, marital status, veteran status, or ability status. We will ensure that individuals who are differently abled are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment as provided to other applicants or employees. Please contact us to request accommodation.

    Our open positions are managed through our Human Resources department. Unsolicited resumes from recruiting agencies, in advance of a specified agreement, will not be accepted. Resumes sent directly to our employees or our consultants from recruiting organizations will also not be accepted as referrals and do not obligate us to pay fees.

    Please send your resume and include the job title and number in the subject.

    Job Reference Number: CS-1007

    * AN2 Therapeutics is based in Menlo Park, CA, but employees are currently working remotely due to the COVID-19 pandemic.