Associate Medical Director
Position: Associate Medical Director/Medical Director
Job Code: 13-610
Reports to: Chief Medical Officer
Location: Cambridge, MA
ABOUT CERULEAN PHARMA, INC.
Cambridge, Ma.-based Cerulean Pharma (www.ceruleanrx.com), a leading nanopharmaceutical company with multiple oncology product candidates in efficacy stage clinical trials around the world.
Cerulean’s nanopharmaceuticals dynamically target tumors by using the large pores of tumor blood vessels as entry portals. These nanopharmaceuticals are small enough to pass through the leaky vasculature of tumors and too large to escape from the blood stream into healthy tissue (see diagram). They release their cytotoxic payloads from within tumor cells over prolonged periods of time leading to high intracellular drug concentrations in tumors while largely sparing healthy cells. Increased tumor localization drives monotherapy efficacy while their unprecedented tolerability observed to-date facilitates their combination with other cancer drugs to achieve synergistic efficacy. Cerulean’s nanopharmaceuticals provide the anti-cancer foundation for a new paradigm in cancer treatment in which cancers can be viewed as manageable chronic diseases and treated with combinations of highly efficacious and well tolerated agents.
Founded in 2006, Cerulean developed its platform from IP licensed from MIT and Cal Tech. Cerulean’s lead candidate, CRLX101, is currently being evaluated in four Phase 2 clinical trials at leading cancer care centers including those of the Dana Farber Cancer Institute, Massachusetts General Hospital, City of Hope, and the University of Pennsylvania. Cerulean’s second candidate, CRLX301, will enter the clinic later this year. The company’s experienced management team is backed by Polaris Ventures, Venrock, Lilly Ventures, Lux Capital, Crown Venture Funds, and Bessemer Venture Partners.
Ceruleanis looking for a highly-motivated and results-oriented individual to join its clinical department in the role of Associate Medical Director/Medical Director. The Cerulean team is passionately committed to winning the war against cancer with dynamically tumor-targeted nanopharmaceuticals. This full-time position will report directly to the Chief Medical Officer and includes responsibility for driving and coordinating the clinical development of the company’s new clinical drug candidate and integrating the preclinical, clinical and competitive data to commercial success.
- Drive and coordinate the clinical development of CRLX301, a docetaxel-containing nanopharmaceutical entering phase 1 clinical evaluations in the 2nd half of 2013. Take a major role in integrating pre-clinical, clinical, and competitive data to generate a development plan that maximizes the clinical and commercial success of the nanopharmaceutical.
- Primary medical point of contact with contracted CROs, investigators, ethics committees, IRBs, and opinion leaders/advisors
- Participation in safety review meetings for cohort reviews of Phase 1 studies as primary Sponsor representative and coordination with Data Monitoring Committee activities
- Preparation of phase 2/3 clinical trial protocols, study reports, amendments and informed consent forms, taking active part in study design in internal discussion/meetings
- Primary point of medical contact across all Cerulean clinical trials for patient safety and eligibility issues including review of safety reports (i.e. SAEs, important medical events)
- Lead implementation of pharmacovigilance activities including SOPs and procedures for preparation of SAE narratives and creation of cumulative CRLX101 and CRLX301 safety databases
- Lead medical writing for clinical protocols and study reports including preparation of clinical sections for FDA reports including IND submissions, EOP2 briefing documents, and annual reports
- Contribute to publication strategy and preparation of abstracts, posters and manuscripts
- Maintain expertise in GCP, clinical trial methodology, and relevant treatment landscapes through attendance at ASCO and/or other educational meetings/conferences
- MD or equivalent training required; oncology drug development experience and/or training in oncology highly preferred
- Minimum 5 years of clinical trial management experience is required; previous industry experience as a study medical monitor or pharmacovigilance monitor or medical affairs role is preferred
- Advanced knowledge of Good Clinical Practice (GCP) for conduct of clinical studies and associated FDA regulations for pharmacovigilance / safety reporting is required; international experience with safety reporting for foreign regulatory agencies is preferred
- Experience with technical writing of clinical sections for FDA dossiers, study reports, clinical protocols, and SAE narratives is required; medical journal publication experience is preferred
- Excellent written and oral communication skills are required; experienced presentation skills and ability to prepare clinical data presentations in PowerPoint is preferred
- Strong interpersonal skills and entrepreneurial can-do attitude essential
- Proficient computer skills including Word and Excel are required; experience with statistical and pharmacovigilance databases or statistical software including SAS is highly preferred
- Willingness and ability to travel up to 20% of time including domestic and international travel
To be considered for the position, please submit your resume to email@example.com and reference the job code 13-610.