Head of Biometrics - Senior Director Biometrics

Location
Cambridge, MA, US
Posted
Nov 13, 2020
Ref
1058
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

Senior Director, Head of Biometrics will be accountable for driving and supervising the company's biometrics activities for all projects from the IND-enabling stage through to the post-launch period. This includes supervision of all the statistical and programming activities (as well as data management for the right candidate). This role will require direct hands-on contributions, as well as oversight of both internal and external biometrics staff. As the portfolio grows, this role will also be accountable for bringing the biometric functions in-house and supervising the growth of the biometrics department.

The Senior Director, Head of Biometrics 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 interactions on accelerated timelines. Expertise in oncology is essential.
• Guides clinical study design and supports data analysis and interpretation.
• Optimizes the development of a precision medicine approach, using well-established statistical principles, but also being willing to offer creative solutions for novel technologies.
• Establish biometrics SOPs, processes, and relevant quality management system.
• Leads biometrics efforts and cross-functional initiatives.
• Supports the project team with innovative approaches to resolve complex strategic issues in protocol design and data analysis.
• Demonstrates technical excellence, delivering "state of the art" biometric strategies across the portfolio
• Builds a highly functional biometrics department to support other Clinical Development functional teams.
• 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 biometrics standards and ensures submissions are aligned with current standards/guidance.
• Leads biometrics due diligence in support of business development transactions
• Act as the subject matter expert in biometry, advising company senior management, medical and clinical operations teams on the most up-to-date biostatistics methodology and tools in drug development.
• Work as a core member in clinical development team, contribute to design a clinical study protocol that is clinical sound and statistically efficient.
• Provide support to the clinical study team on the collection, interpretation and reporting of clinical data.
• Ensure the statistical analysis and the submission datasets meet the regulatory requirements.
• Represent the company as Biometry expert in the communication with regulatory agencies.
• Manage biometry resource allocation to support company's clinical trial projects and recruit appropriate talents if needed.
• Participant in recruitment process within the context of the site budget and hiring strategy, typically has decision-making authority for hiring of Biometry.
• Coach and mentor junior members of the biometry staff on issues associated with trial design conduct, analysis, and reporting.
• Ensure continued career development for members of the biometry staff through selection of work assignments and on-going coaching and training.
• Contribute to quality control of biometric and other activities.
• 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 Biometry 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 biometry. Experience in one or more small or mid-sized biopharmaceutical company is strongly preferred. Oncology experience required.
• Track record of successfully working within individual protocols and across projects to design, drive and execute statistical strategy.
• Innovative strategist with an eagerness to see the big picture above and beyond a strict biometric focus.
• Ability to manage self, lead and manage others in the successful and timely completion of all statistical activities for a study or multiple studies from end to end.
• Excellent oral and written English communication skills.
• Excellent communication, analytical and organizational skills
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Experience working effectively in a globally dispersed team environment with cross-cultural partners.

Work Location:

The role will be based out of the Cambridge office, and preference will be given to candidates who live in Massachusetts.

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.

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