Sr. Director, Pharmacovigilance Contractor

Location
Cambridge, MA
Posted
May 04, 2021
Ref
2021-1100
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.

Responsibilities

As the Senior Director of Pharmacovigilance Contractor, you will lead and manage the Pharmacovigilance and Drug Safety function for all product candidates globally, act as a key contributor to clinical development plans, and manage all relevant reporting to global health regulatory authorities.

Initially, this role will be very hands on, with frequent cross-functional collaboration and excellent working relationships with many internal functions such as Clinical Science, Clinical Operations, Biometrics, Regulatory, Non-Clinical and the Senior Executive Team, with the opportunity to build a team in accordance with progress of the Company’s products and product candidates.

 

Your main responsibilities are:

  • Lead, guide and manage the safety aspects of clinical development plans for all product candidates in all stages of development, ensuring that appropriate drug safety techniques and principles are incorporated, particularly risk/benefit profile considerations
  • As the global pharmacovigilance Leader, will review all clinical trial safety data, and preform trend analysis to identify any emerging safety concerns.
  • Author, review and/or approve the preparation of relevant sections of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) and other regulatory documents, including, clinical protocols, Statistical Analysis Plans (SAPs), clinical study reports, Investigator Brochures (IBs)As the company grows, you will be responsible for building and managing a team of safety experts.
  • As the company grows, you will be responsible for building and managing a team of safety experts.
  • Provide guidance to product/program teams and CROs for safety case review and adjudication.
  • Broad knowledge of clinical development and/or safety requirements from preclinical to post marketing.
  • Participate in the review and interpretation of clinical trial results, particularly for understanding and interpretation of product safety.
Qualifications
  • PhD, Doctorate or MD
  • At least 10 years of experience in pharmacovigilance, product safety and/or clinical operations within the biotech or pharmaceutical industry
  • Strong communication skills and ability to work well collaboratively across the organization.
  • Experience in designing or implementing safety reporting/safety management processes, systems and tools to support both case-level review and trend analyses.
  • Ability to implement product and study-level risk assessment and risk mitigation into global drug development.
  • Experience with oncology
  • Knowledge and experience in signal detection methodologies
  • Expert knowledge of global safety reporting regulations, including US, EU, and UK requirements
  • Knowledge in Regulatory audits and inspections, as well as management of partners and vendors

 

 

Work Environment:

This job operates in a professional office and lab 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.