Associate Director / Director, Clinical Pharmacology

Location
Cambridge, MA, US
Posted
Nov 04, 2020
Ref
1053
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Overview

Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company's proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations

Black Diamond is currently seeking a Clinical Pharmacology project lead. Reporting to the VP Preclinical Development, the incumbent will be the clinical pharmacology representative on project teams developing small molecule modulators as precision cancer medicines. We are looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development.

Responsibilities
  • In partnership with functional/project leaders, set the clinical pharmacology strategy and plans for Black Diamond's programs in clinical development. Be the functional area representative for clinical pharmacology on project teams
  • Lead the planning, design, conduct and analysis of standalone clinical pharmacology studies in collaboration with internal cross-functional team. Work closely with DMPK in the design and integration of clinical PK/PD activities, collaborate with Clinical Operations in the planning and conduct of clinical PK studies.
  • Oversees activities including non-compartmental PK analysis, population PK, PK/PD, physiologically-based, and other modeling and simulation (M&S) approaches. Coordinates with internal and external team in the data review, analysis and reporting of clinical pharmacology sections of CSRs including PK and pharmacometrics analyses.
  • Author and review clinical protocols, study reports and prepare relevant sections of regulatory documents, including INDs, clinical trial applications (CTAs), Investigator Brochures, regulatory Briefing

Qualifications
  • An advanced degree and 7-10+ years of experience in the biotech/pharmaceutical industry, with a focus in clinical pharmacology, pharmacokinetics, pharmacometrics or related discipline.
  • Previous experience in managing clinical pharmacology programs, and in the design, execution, and regulatory reporting of clinical PK/PD studies is required.
  • Technical depth in clinical pharmacokinetics, PK/PD analysis, and M&S approaches, preferably with experience in oncology. Experience applying M&S in preclinical development a plus.
  • Experience conducting clinical pharmacology programs through early and late-stage development.
  • Operational experience and familiarity with the drug discovery and development process, including external regulatory requirements. Well versed in authoring and reviewing relevant sections of regulatory dossiers.
  • Proficient in the management of activities at contract research organizations and comfortable working in virtual outsourced model.
  • Excellent communication and organizational skills; comfortable navigating complexity and ambiguity in a fast-paced environment interacting with consultants, external vendors and internal cross-functional, global project teams.


The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.

Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Black Diamond Therapeutics values our relationships with our Recruitment Partners and will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. Black Diamond is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Black Diamond who is not a member of the Human Resources team