Vice President, Head of Regulatory Affairs

Location
Cambridge, MA, US
Posted
Sep 29, 2020
Ref
1052
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 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.

The VP, Head of Regulatory Affairs will be accountable for driving and supervising the company's global regulatory activities across all stages of development, for all programs, both pre-clinical and clinical. This role will require direct hands-on contributions, as well as oversight of the growth and supervision of the Company's regulatory organization.

The VP, Head of Regulatory Affairs will be a senior member of the CMO's Clinical Development Leadership Team (DLT), and 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 regulatory (strategic and tactical) activities on accelerated timelines, ideally including successful global marketing submission and launch. Expertise in precision-medicine small molecule therapeutics is strongly preferred.

Responsibilities
  • Guides global regulatory strategy and tactics in line with the company vision.
  • Designs, coordinates, directs, and conducts all global regulatory interactions.
  • Nourishes healthy and productive relationships with global regulators, acting as primary regulatory contact with the FDA, international regulatory agencies and other regulatory bodies.
  • Optimizes the development of a precision medicine approach, with integrated drug/diagnostic regulatory and submission plans, including engagement plans and mitigation strategies for regulatory agencies.
  • Manages the preparation of all global regulatory submissions (from INDs to marketing applications) to the FDA and other global regulatory agencies for precision cancer medicines and companion diagnostic tests.
  • Manages on-going regulatory submission and reporting requirements.
  • Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.
  • Builds and manages a team to support regulatory activities across programs and electronic submissions.
  • Provides guidance and recommendations to key stakeholders within the organization
  • Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for drug and diagnostic products.
  • Remains current with regulatory intelligence and ensures submissions are aligned with current standards/guidance.
  • Provides regulatory oversight for product development, manufacturing and distribution.
  • Provides overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
  • Remains on the forefront of the relevant science, competitive landscape and policy including detailed competitive intelligence and provides Executive Leadership Team with assessments of the impact of new and changing regulations on the Company's programs.
  • Leads regulatory due diligence in support of business development transactions
  • Ensures adequate resourcing of the regulatory organization by anticipating needs in advance and filling gaps, as needed with consultants, contractors and/or full-time employees, responsibly helping to shepherd the company's financial resources.
  • Monitors compliance with regulatory requirements and commitments.
  • Holds themselves and their teams to the highest levels of integrity, in line with company values
  • Collaborates well with peers and mentors the junior staff.

Qualifications
  • 15+ years' experience in regulatory affairs. Experience in one or more small or mid-sized biopharmaceutical company is strongly preferred.
  • Oncology experience required, including with small molecules/precision medicine clinical programs; experience with CDRH and the development of companion diagnostics is highly desired
  • At least five years' experience in managing a regulatory team
  • PharmD or PhD preferred; Bachelor's degree required
  • Proven ability in leading and directing regulatory affairs activities from pre-IND through global marketing application (e.g. NDA/BLA/MAA)
  • Direct experience in developing strategy and leading teams through interactions with health authorities
  • Track record of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components
  • Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
  • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory 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


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