Medical Director/Senior Medical Director

Location: South San Franciso, CA

Department: Development Sciences

Type: Full Time

Min. Experience: Senior Manager/Supervisor

Position Summary:

The Medical Director/Senior Medical Director, reporting to the Head of Late Development, will play a pivotal role in the clinical development of the Company’s compounds. He or she will lead the strategic discussion around clinical development programs, trial design, assist in writing the protocols, and then play a vital role in the planning and execution of the clinical trials. He or she will provide clinical expertise to key study plans and processes such as investigator meetings, eCRF design, drafting of informed consents and investigator brochures, data management, study monitoring, data analysis, completion of study reports, and publication of key findings. The Medical Director/Senior Medical Director will work closely with medical consultants and key opinions leaders in infectious disease and other relevant specialties from around the world to ensure that studies are clinically relevant and thoughtfully designed to meet the objectives in the target product profiles and the target labels. The successful candidate should also be experienced and proficient in interacting with regulatory authorities.

 

Essential Functions:

  • Work with the Head of Late Development and project core teams to plan and implement the clinical development of the Company’s products in a way that is consistent with corporate goals and timelines.
  • The Medical Director will play an active role on the plazomicin project, which may include monitoring of ongoing studies, including collaborative studies with external groups, ensuring quality data analyses and preparation for Health Authority submissions as appropriate.
  • The successful candidate will also provide medical support to early development programs and to medical affairs and commercial groups.
  • Play a pivotal role on Product core teams and sub-teams providing clinical expertise to all aspects of trial design and conduct.
  • Assist with selection of CROs and other vendors and development of budgets for clinical trials.
  • Plan and execute clinical research and data collection.
  • Monitor the conduct and safety of clinical trials.
  • Interpret the findings from clinical research.
  • Establish and maintain pertinent standard operating procedures for clinical research.
  • Ensure that Company-sponsored clinical research is conducted in a manner that is in full compliance with all pertinent governmental regulations.
  • Play an important role in discussions, communications, and negotiations with Regulatory authorities, including INDs, NDAs, MAAs, meeting packages, teleconferences, and meetings.
  • Be responsible and accountable for the clinical aspects of communications with regulatory authorities.
  • Provide scientific and clinical expertise in support of business development activities as needed, including the evaluation of potential in-licensing opportunities.
  • Represent the Company in a positive fashion and develop and maintain key relationships with clinical and research communities and key opinion leaders.
  • Understand the competitive landscape relating to clinical and pre-clinical programs, in order to help guide development strategy.

 

Preferred Experience:

  • Clinical and scientific background in infectious disease and/or clinical expertise in infectious disease desirable.
  • Experience in translational research and in patient selection strategies, including the development and use of investigational diagnostic assays or devices in clinical trials.
  • Three or more years with direct, industry-related product development experience in pharmaceuticals, biopharmaceuticals or biotechnology industries. At least 5 years’ experience for the senior medical director position.
  • Solid experience with protocol design, evaluation, and conduct.
  • Experience with a small to medium sized biotech preferred.

 

Preferred Education:

  • MD required.
  • Advanced degrees must be from an accredited institution.
  • Board certification is a plus.

 

Preferred Additional Skills:

  • Experience with Word, Excel, PowerPoint, Outlook or equivalent.
  • Experience in working with CROs for the execution of clinical trials.
  • Willingness to be a hands-on, roll-up-your sleeves team member in a lean organization.
  • Effective verbal and written communication skills.
  • Experience in presentations to internal and external groups.
  • Strong organizational, interpersonal and computer skills a must.
  • Excellent team interaction skills along with demonstrated ability to work in a cross-functional team and influence the decisions of a team.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically and internationally.
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