Senior Medical Director
South San Francisco, CA
We are currently searching for a skilled professional to join a well-known client’s team as Senior Medical Director. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- 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 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
- Clinical and scientific background in infectious disease and/or clinical expertise in infectious disease, critical care/pulmonary medicine, internal medicine desirable.
- Experience in translational research and in patient selection strategies.
- Three or more years with direct, industry-related product development experience in pharmaceuticals, biopharmaceuticals or biotechnology industries or equivalent experience within academia. 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.
- 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.
- MD or PharmD with relevant experience
- Advanced degrees must be from an accredited institution
- Board certification is a plus
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.