Vice President Clinical Biomarkers and Companion Diagnostics

Location
Cambridge, MA, US
Posted
Mar 24, 2021
Ref
1084
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
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 agents are designed to target previously undruggable 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 oral small molecule therapy "Masterkey" agent designed to target a specific family of mutations in a tumor-agnostic fashion.

BDTX-189, the company's first Masterkey therapy, is currently completing phase I and is expected to enter phase II by mid-2021. Because this agent, and all the agents in the Black Diamond portfolio are rooted in "next generation" precision medicine, the Senior Director of Translational Medicine will play a seminal role in the company's success, by helping to guide strategy and tactics within Discovery and directly supervising all aspects of biomarker and Companion Diagnostic development before and after IND.

Responsibilities

We are seeking a Vice President, Head of Clinical Biomarkers and Companion Diagnostics, who will be accountable for driving and supervising the company's global goals in precision medicine for all assets, from Discovery to Launch. This role will require direct hands-on contributions, as well as oversight of the growth and supervision of the company's Clinical Biomarkers and Companion Diagnostics organization.

The VP, Head of Clinical Biomarkers and Companion Diagnostics, will be a senior member of the CMO's Clinical Development Leadership Team (DLT), and will work closely with other members of the DLT to support a high-performing cross-functional team. As such, the successful candidate must have significant experience in all phases of cancer drug development, with a track record of successful development of a precision-medicine and associated companion diagnostic.

Responsibilities
  • Drive and guide the design, coordinate, and manage the Clinical Biomarker and Companion Diagnostic strategy and tactics for all Black Diamond precision-medicine agents, from Discovery to Launch.
  • Ensure high quality collaboration with the Discovery Research groups guiding the strategy and execution of all pre-clinical efforts required to set up for success each of the Company's precision-medicine agents during the pre-IND period.
  • Drive and guide the design and coordinate the tactics for the biomarker elements/companion diagnostic elements of all clinical studies.
  • Oversee the biomarker/companion diagnostic content of all key clinical and regulatory documents including the Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions and responses (INDs/CTAs) and assist in the development of publications, abstracts, and presentations.
  • Oversee the development and monitor the quality of pharmacokinetic, pharmacodynamic and patient stratification biomarker assays to support the advancement of preclinical programs into the clinic.
  • Oversee the design and implementation of biomarker analysis in clinical trials, ensuring operational execution by partnering with biomarker labs and data management according to cGCP guidelines.
  • Work with a cross functional team (medical directors, nonclinical and discovery research scientists, regulatory, clinical operations) to ensure early definition of, and agreement on biomarker strategy for clinical development and regulatory approvals.
  • Maintain up-to-date knowledge of scientific and clinical published literature in oncology, tumor biology and the competitive landscape.
  • Partner with biostatisticians and biomarker laboratories to establish biomarker analysis plans to ensure delivery of high-quality data to support analysis, interpretation, and reports of clinical biomarkers for internal decision-making and Health Authority submissions.
  • Provide innovative approaches to resolve complex clinical and regulatory issues to increase the speed and quality of the approvals
  • Provide guidance and recommendations to key stakeholders within the organization
  • Build the Clinical Biomarkers/Companion Diagnostics organization, ensuring adequate resourcing of the Clinical Biomarker and companion diagnostic function by anticipating needs in advance and filing gaps, as needed, with consultants, contractors and/or full-time employees, responsibly helping to shepherd the company's financial resources.
  • Monitor compliance with regulatory requirements and commitments.
  • Hold themselves and their teams to the highest levels of integrity, in line with company values.
  • Collaborate well with peers
  • Mentor junior staff

Qualifications
  • Advanced scientific degree (Ph.D., Pharm.D.), with minimum 10 years of relevant work experience developing biomarkers, including a minimum of 5+ years in a leadership role developing translational medicine strategies and managing a translational medicine team.
  • At least 5 years managing a Clinical Biomarker and/or Companion diagnostic team
  • Direct experience in developing strategy and leading teams through interactions with relevant health authorities in CDER/CBER and CDRH in the US and relevant health authority personnel outside the US.
  • Track record of issue resolutions with relevant clinical and/or regulatory stakeholders; demonstrated ability to break down complex, scientific content into logical components.
  • Knowledge of biomarker development and implementation in early stage oncology drug development to support clinical assay development/validation for mechanism of action, proof of biologic activity, proof of concept, patient stratification and response prediction markers.
  • Experience with developing and documenting clinical and regulatory strategies in coordination with clinical plans and marketing objectives.
  • Experience with communicating precision-medicine strategy, issues, and risks in written and verbal format to company senior leadership team and other governing bodies.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
  • Excellent communication, analytical and organizational skills.

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment.

Physical Demands:

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.