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

Location
New York, NY, USA
Posted
Oct 25, 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 Clinical 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 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 NYC office.

Job Responsibilities will include:
  • Monitor clinical trials for safety, efficacy, and adherence to protocol requirements and query clinical data for accuracy and completeness. Work in conjunction with Clinical Development and Clinical Operations teams to ensure timely reporting of safety signals.
  • Review and interpret data and analyses from clinical studies, including raw data files, summary tables, figures, and listings.
  • Write, review, edit and QC applicable documents, synopses, protocols, amendments, case report forms, study reports, narratives, investigator brochures, informed consent forms, adverse event/concomitant medication coding, data validation specifications, manuscripts, clinical development plans and statistical analysis plans, that meet scientific and regulatory standards as applicable.
  • Oversee, participate, or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review, or other study-related meetings.
  • Prepare and participate in scientific and capability presentations conferences and professional meetings.
  • Participate in and/or lead process improvement initiatives such as establishing and improving document standards, process mapping & documentation, SOP authoring, review and revision, gap analysis and resolution of department training plans & SOPs or other procedures.
  • Resolve issues and escalate problems as necessary.
  • 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.

Qualifications:
  • Medical Degree (i.e. MD, MBBS, MB ChB, MB BCh) Internal Medicine specialty preferred.
  • At least 3 years of post-graduate clinical experience in a medical facility (residency, direct patient care), required.
  • Four years of pharmaceutical or biotech experience in which two years should be with a small pharmaceutical or biotech company.
  • Clinical Development focused experience in Phase 1 and 2 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 are required.
  • 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