Job Details
A clinical-stage biotechnology company based in San Francisco, backed by Third Rock Ventures, is harnessing the power of adipocyte biology and the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company is building a pipeline of therapies that target rare and common cardiometabolic diseases. The company s lead program is in Phase 2 clinical development for a number of cardiometabolic indications. This soon to launch company is led by a dynamic team of scientists and company builders with deep know-how and experience in cardiometabolic diseases, human genetics and adipocyte biology.
Reporting the CMO, the Director/Senior Director, Clinical Development will be the clinical and medical strategic lead of one or more products/therapeutic areas, accountable for all applicable early and late clinical projects IND enabling through Ph2). The Clinical Development Director will ensure the planning, implementation, managing, and reporting of the applicable pre-clinical and clinical studies in accordance to the product development plan.
The incumbent will have primary responsibility for providing product development status updates to the R&D Leadership Team. The incumbent will support Medical Affairs and R&D Operations teams with medical/clinical oversight and/or guidance on collaborative research programs applicable for one or products for which he/she is accountable.
JOB RESPONSIBILITIES:
Product Development
- Lead and strategize the generation and implementation of product development plan (inclusive of target product profile, clinical development plan) for one or more products
- Provide leadership for the R&D team members for the planning and execution of the pre-clinical and clinical programs in accordance with the product development plan (inclusive of target product profile, clinical development plan)
- Ensure that scientific rigor and innovation continues to be integrated into and drives Company s development strategies
Clinical Trials
- Guide and organize the team members for the planning, implementation, managing, and reporting of clinical trials and programs
- Prepare, review, and approve clinical trial content and documents including synopses and protocols, Investigator Brochures, and clinical study reports
- Review and approve Medical Monitoring Plan, Safety Plans, Protocol Deviation Plans
- Review Statistical Analysis and long term strategy plan shells
- Ensure studies are conducted according to GCPs and organizational SOPs
- Contribute to the preparation of IND/NDA clinical sections
- Serve as medical monitor and representative to multiple vendors and collaborators including CROs, PIs, core laboratories, and other organizations involved in the implementation of a clinical trials
- Work closely with internal team and CRO in execution of trials, and provide ongoing guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategies
- Work with R&D Operations and/or Finance on the clinical study budget and timelines
- Work/Guide R&D and Regulatory teams on clinical/medical responses to regulatory agency queries, meetings preparations and review of briefing packages
- Review/approve of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov and/or TPRs
- May be expected to represent company at joint development committee as well with global regulatory agencies
Clinical Study Publication
- Lead the creation, review and approval of abstracts, posters and manuscripts for pre-clinical/clinical studies in support of the publication strategies for assigned brands
Stakeholder Management
- Provide product development status to Senior R&D Leadership Team
- Provide sound clinical development guidance to key stakeholders across organization
Business Development
- Function as the Clinical Lead for business development activities by evaluating new product potential
SKILLS AND ABILITIES:
- Experience in pharmaceutical research, specifically exposure to the IND/NDA/BLA approval process, Phase 1 and 2 clinical research
- The incumbent should have an MD or MD/Ph.D and at least 5+ years of directly related biotechnology/pharmaceutical clinical research experience
- The incumbent must have demonstrated experience in clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information
- Professionalism, critical thinking, evidence-based reasoning, and a team-oriented outlook are of the utmost importance
- Proficiency in critical aspects of early and late development required for the job, specifically knowledge of the development path for the therapeutic areas, FDA and ICH regulations, GMP/GLP/GCP
- This position also requires a working knowledge of software packages (e.g., MS Word, MS Excel, MS PowerPoint)
- The ability to work on a team and effectively communicate with a diverse audience are essential
- Excellent communication (written and oral) skills are required
- Demonstrates the ability to analyze complex situations and proactively identify opportunities/issues; effectively solves problems that cross functional boundaries
WORKING CONDITIONS:
- Prolonged periods of being at a stationary desk or work computer
- Ability to occasionally adjust, handle, or move objects up to 20 pounds
- Ability to assess the accuracy, neatness, and/or thoroughness of the work assigned
- Willingness and interest to work on site in our San Francisco office for a minimum of 3 days per week
We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans and all other qualified applicants.