Director, Precision Medicine - Early Clinical Development
The Director, Precision Medicine will support Clinical Development efforts across the development portfolio (first-in-human through Phase IV) and be responsible for developing and executing strategies to advance pipeline via Proof-of-Mechanism, Proof-of-Concept, as well as supporting late-stage Phase II-IV strategies. This role sits within the Clinical Development organization, which covers all patient studies. The role collaborates with other key functions, including Research, Clinical Operations, Regulatory Affairs, and Manufacturing to advance the precision medicine department’s efforts.
· Provide leadership across the therapeutic and functional areas providing internal subject matter expert for clinical immunology, oncology, and immune-oncology.
· Collaborate with colleagues to evaluate new indication opportunities for existing development candidates and in-licensing opportunities.
· Present results and updates of projects at department, team, corporate and scientific meetings.
· Design and champion compound and disease centric CBD strategies to team and senior management
· Assist medical writing in the preparation and review of clinical study reports, and CBD sections of CDPs, IBs, INDs, BLAs, abstracts, manuscripts, and technical reports.
· Execute the approved CBD strategies, and ensure an integrated (consistent) approach for each development program, from FIH through registration, and across indications.
· Identify, contact, discuss, qualify, vendors/CRO’s in the CBD space. Review and revise statements of work (SoW), negotiate pricing, and decide on external vendor/CRO contracts in the TPM space. Move assays out of the lab to CRO’s and qualify assays at CRO’s
· Review statistical analysis plans for CBD studies, review and interpret TLF’s to enable timely internal decision-making and external communication with investigators and regulatory agencies and lead the preparation and assure the accuracy of the CBD-section of clinical study reports.
· Collaborate with leadership on medical communications in support of knowledge generation for the product franchise by generating and packaging content for MoA abstracts, posters, and manuscripts, reviewing IISP’s, and leading and facilitating investigator meetings, advisory boards, CRO selection, site/investigator selection and monitoring.
Experience & Education
- MD, PhD, or PharmD with 9-14 years of relevant CBD experience.
- Formal education or significant experience in immunology with deep knowledge in biomarker-driven clinical studies in respiratory, oncology, and/or immunology
- Ability discovering and replicating clinical biomarkers for internal decision-making
- Skills in clinical trial design and operations
- A demonstrated ability and willingness to multi-task
- Excellent oral and written communication skills, as well as interpersonal skills
· Some travel (<10%) will be required
- Skills in genetic/genomic data analysis, statistics, and/or modeling, molecular biology or companion or complementary diagnostic FDA/EMA regulations, e.g. filing experience, agency meetings, requirements, guidance, etc. preferred