Medical Director/ Sr. Medical Director, Clinical Development
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 Clinical Development team at Black Diamond Therapeutics is looking for an agile, self-motivated, and experienced individual to serve as the Director, Medical Monitor to support clinical teams. The successful candidate will be detailed oriented, self-directed and with the ability to be flexible and manage workload to meet project timelines.Responsibilities
- Providing clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management.
- Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
- Collaborates with external opinion leaders and Principal Investigators and internal clinicians, translational sciences, and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
- Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase 1-3 studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations.
- Directs the planning, preparation, writing and reviews of aggregate medical safety reports in coordination with the program’s Pharmacovigilance/Safety lead.
- Works with study and program teams to achieve program goals and provides deliverables in approved timeframes.
- Supports the development of regulatory documents for filings and agency meetings.
- Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
- Proactive identification of issues/problems and recommends solutions.
- Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
- Remains up to date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
- Maintains knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing.
Experience and Qualifications
- Medical Degree required
- Preferred 8+ years of broad bio/pharmaceutical industry experience in drug development with therapeutic expertise in oncology, and specifically small molecule development
- Ability to work with a high level of autonomy/independence.
- Small biotech experience preferred.
- Strategic abilities and capability to take the lead and “ownership” of programs within specific indication areas.
- Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data.
- Availability to participate in early or late meetings/teleconferences.
- Able to manage priorities and competing demands in a changing work environment.
- Strong oral & written scientific communications skills.
- Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings)
- Ability to strike proper balance between independent work and team interaction, good team player in a cross functional team.
- Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
- Ability to travel up to 20%, including international travel.
This job operates in a professional office environment with travel activities of approximately 20-30% of the time.
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