Associate Medical Director - Oncology Therapeutics

Confidential Company  •  Cambridge, MA and Cambridge, MA

5 - 7 years experience  •  Life Sciences & Research

$140K - $275K
Posted on 12/02/17 by John Rynak
Cambridge, MA
5 - 7 years experience
Life Sciences & Research
$140K - $275K
Posted on 12/02/17 by John Rynak

Associate Medical Director - Oncology Therapeutics

Location: Cambridge, MA

 

We are seeking a highly motivated and enthusiastic physician with hands on expertise in taking novel oncology compounds from first in human through to completion of phase 2clinical trials. This will support H3’s continued effort to identify unique anti-cancer compounds for the treatment of targeted patient populations.  The main focus managing all aspects related to the planning and execution of global clinical trials and will be responsible for the conduct of multiple clinical trials in hematologic malignancies and will report to the CMO. The successful candidate will function as a scientific and medical resource for the Clinical Development department at H3 Biomedicine as well as a liaison to development partners. Preparation of study related materials, relationship management between study sites, leveraging internal and external (CRO) development resources and the supervision of all other study related activities. The individual in this role will also be responsible for the identification of project risks, contingency planning implementation and operating within the project timelines and budget.

 

RESPONSIBILITIES FOR THIS POSITION INCLUDE:

 

 Drive and coordinate clinical development activities, including leading clinical study teams, monitoring overall study integrity and setting clinical strategy.

 Take a major role in integrating pre-clinical, clinical, and competitive data to generate a development plan that maximizes opportunities for clinical and commercial success of the molecule

 Serve as a primary medical point of contact with contracted CROs, investigators, ethics committees, IRBs, and opinion leaders/advisors

 Participate in safety review meetings for cohort reviews of Phase 1 studies and coordinate where relevant with Data Monitoring Committee activities

 Prepare clinical trial protocol drafts, study reports, amendments and informed consent forms, taking an active part in study design in internal discussion/meetings

 Serve as a primary point of medical contact across all H3clinical trials and programs for patient safety and eligibility issues including review of safety reports (i.e. SAEs, important medical events)

 Participate in implementation of pharmacovigilance activities including SOPs and procedures for preparation of SAE narratives and creation of cumulative safety databases

 Coordinate 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 othereducational meetings/conferences

 

QUALIFICATIONS INCLUDE:

 MD or equivalent training required; oncology drug development experience and/or training in oncology highly preferred

 Minimum 5years 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 is 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

Cambridge, Ma.-based H3 Biomedicine () is a leading company in cancer genomics based drug discovery, delivering on the promise of precision medicine. The company was launched in 2011 with an unprecedented $200 million funding commitment from Eisai plus additional funding for clinical programs. Now with three clinical stage anti-cancer molecules in active development, H3 is able to uniquely leverage distinct insights from cancer genomics and real-life patient data to advance its projects to clinical proof of concept and beyond. H3 embraces a novel business model in which it collaborates with Eisai, a leading global pharmaceutical company, to create a prolific drug discovery engine and partnership platform

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