Director of Clinical Pharmacology

Location
Austin, TX, USA
Posted
Jun 09, 2021
Ref
294441
Hotbed
Lone Star Bio
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics. Our proprietary biologic drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer and other serious diseases. MTEM currently has multiple clinical-stage ETB candidates in development including MT-5111, TAK-169, and MT-6402. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

MTEM is recruiting a highly motivated scientist with a strong background in clinical pharmacology to identify, design, develop and execute on the clinical pharmacology (Clin Pharm) objectives of hematologic malignancy, solid tumor oncology, and immuno-oncology programs for the Clinical team. This individual will take leadership efforts in working collaboratively with both internal Research and Development and Clinical Development colleagues and external partners to support and execute these efforts. The successful applicant must be able to handle a dynamic and fluid environment in support of efforts to bring new therapies to patients.

Job Responsibilities:
  • Lead the Clin Pharm group to support Clinical Development goals, and build the capabilities and staffing requirements of the Clin Pharm group commensurate with the needs of MTEM
  • Direct the activities of the Clin Pharm group to study the effects of ETBs in humans via analysis of in vivo and in vitro pharmacokinetics, pharmacodynamics, and drug metabolism studies
  • Conduct quantitative evaluation of ETBs through the application of state-of-the-art knowledge in analytic epidemiology, pharmacokinetics (PK), pharmacodynamics (PD), and bioanalytical chemistry
  • Design and plan PK endpoints in early clinical development studies to enable RP2D identification for oncology programs
  • Lead explanation of Clin Pharm objectives and endpoints including sample collection and storage at Site Initiation Meetings
  • Anticipate and plan for the availability of sufficient PK data to generate population PK analyses of Phase 2 datasets
  • Conduct analysis of PK and PD data using programs such as WinNonlin, NONMEM, Excel
  • Provide guidance for Clin Pharm plans including drug-drug interaction, special population, safety studies, and pediatric development
  • Manage Clin Pharm sample logistics as laid out in each study protocol, and coordinate between the central laboratory and sites
  • Manage timelines for sample testing and data transfer with external vendors and/or internal teams
  • Single point of contact for all clinical sample management. Manage sample transfer and resolve discrepancies with Central Lab, Clinical Site, and CRO vendors.
  • Coordinate agreements between MTEM and external vendors in support of these efforts
  • Manage on-site storage of samples with routine inventory reviews
  • Work with Preclinical Research team to integrate Clin Pharm data from animal models to intelligently design the clinical PK strategy
  • Work with Translational Science team to integrate Clin Pharm data with PD data and help to plan PD assays to determine drug activity
  • Collaborate with Translational Medicine team to research and develop the biomarker strategy for new projects
  • Work closely with Clinical Development, Clinical Operations, Biostatistics, Data Management, and Regulatory Affairs
  • Assist in the development and maintenance of a central biorepository database (e.g. Laboratory Information Management System)
  • Review and provide feedback on clinical study protocols, laboratory documents, and service provider laboratory scope-of-work documents for sample handling details
  • Provide Clin Pharm summary documents for regulatory submissions (INDs, CTAs, IMPDs, BLAs, etc.) and content for relevant clinical documents (Investigator Brochures, protocols, Informed Consent Forms, etc.)
  • Manage the Clin Pharm budget
  • Consistently evaluate improvement to processes
  • Manage the accuracy and incorporation of Clin Pharm data for medical congress abstracts, posters and presentations, Clinical Study Reports and manuscript development
  • Maintain a high standard for good clinical practice, compliance, and ethics


Qualifications:
  • PhD in Biochemistry/Molecular Biology, Immunology, Pharmacology, or a related field, MD or PharmD and postdoctoral experience is highly preferred.
  • Ten+ (10) years' experience in the conduct of Clin Pharm analyses
  • Five+ (5) years' experience in pharmaceutical or biotechnology industry, ideally in basic research of therapeutics
  • Hands-on technical proficiency and understanding of the basis/background of key PK assays
  • Effective organization, planning, and time management
  • Flexibility and resilience are required to work in a dynamic environment. Proven ability to work under pressure and deadlines.
  • Excellent communication and written skills.
  • Proven productivity as demonstrated by publications/presentations/patents in key meetings or peer reviewed publications
  • Ability to master the use of key software is a bonus (Spotfire, JMP or others)
  • Technical knowledge to maintain electronic files and experience with database entry (e.g. LIMS/ELN) is a bonus.


Location: Austin, TX; NY, NY or Remote

Reporting Structure:

This position does not currently have any supervisory responsibilities. This role reports to the Chief Medical Officer.

Molecular Templates celebrates and supports our differences and is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other legally protected characteristic.

MTEM is committed to providing reasonable accommodations for qualified individuals. If you need assistance with your application due to a disability, you may contact us at: careers@mtem.com.

By submitting a resume for consideration, applicants verify that they have read MTEM's Applicant Privacy notice. https://www.mtem.com/privacy-policy

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