Director/ Sr. Director of Clinical Development (Medical Director)

Location
New York, NY, USA
Posted
Aug 27, 2020
Ref
169146
Required Education
Doctorate/PHD/MD
Position Type
Full time
Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma, and its second compound, MT-5111 is in clinical development for HER-2-overexpressed solid tumors. A third IND is planned for Q4 2020. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly motivated, independent and dynamic physician who will play an important role in advancing Molecular Template's clinical programs, reviewing clinical data from ongoing studies and designing all study-related documents for new trials. As a member of the clinical development team, the Medical Director will serve as the initial medical review for all safety and efficacy data from ongoing trials. This is a unique opportunity for a physician to apply his/her skills in a small entrepreneurial environment with autonomy, responsibility, and accountability. As such, it is critical that the Medical Director is able to collaborate with the Clinical Development and Clinical Operations teams and with external partners including Data Management, Biostatistics and Programming, having facility with the most important features of clinical trial conduct including enrollment and adherence to clinical protocols. The position will be based out of the NY site.

Job Responsibilities will include:
  • Monitor clinical trials for safety, efficacy, and adherence to protocol requirements and query clinical data for accuracy and completeness
  • In coordination with the Clinical Development and Clinical Operations teams, and with Medical Writing, help to design and write new clinical trials, protocol amendments and related documents (i.e. ICF's) for MTEM's investigational medicines
  • Work with other functional areas (i.e. Clinical Pharmacology) to ensure data are collected correctly and consistent with clinical protocols.
  • Work with contract vendors to facilitate the collection and evaluation of clinical trial data.
  • Work across line functions in the review of clinical development documents (protocol, ICF, IB, DSUR, ASR, abstracts, and publications)
  • Work in conjunction with Clinical Development and Clinical Operations teams to ensure timely reporting of safety signals

Qualifications:
  • Medical Degree (i.e. MD, DO, MBBS, MB ChB, MB BCh)
  • At least 3 years of post-graduate clinical experience in a medical facility (residency, direct patient care), required.
  • At least two years of either large pharma or biotech experience in Clinical Development focused on Phase 1, 2, and/or 3 clinical research studies
  • Experience working with Clinical Research and Clinical Operations teams and allied line functions such as Clinical Pharmacology
  • Excellent written and verbal English communication skills and proven ability to work in a collaborative environment.
  • Familiarity with Clinical Development software (i.e. EDC's such as Medidata Rave; data cleaning tools such as Spotfire, etc.)
  • Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships.
  • Excellent organizational and time management skills, ability to lead and manage multiple complex projects.
  • Demonstration of Molecular Templates values in previous employment
  • Ability to work proactively and effectively using creative problem-solving skills.


Reporting Structure:

This position currently has no supervisory responsibilities. This position will report to the SVP, Clinical Development.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com