This position reports to the Head of Translational Medicine and will work in a collaborative, cross-functional project team environment. The successful candidate will bring proven leadership skills and a strong background in clinical research in cancer therapeutics. This person will be involved in the translational clinical activities across a growing, early-stage portfolio of small molecule therapeutics, including the implementation of strategic development plans and actively participating in the conduct of clinical studies for multiple development-stage programs at FORMA Therapeutics Inc. 

Responsibilities

• Implement clinical development strategies/plans for novel drug candidates in oncology and non- oncology indications as part of a cross-functional project team.
• Work closely with the Head of Translational Medicine, project teams and the Translational Biology group to incorporate the therapeutic directions and patient selection strategies into clinical protocols
• Support the medical monitor for clinical protocols
• Partner with Clinical Operations on clinical trial conduct and monitoring, including GCP, patient eligibility, safety monitoring, AE and SAE tracking and reporting and protocol deviations
• Support timely and high quality cleaning, analysis, interpretation and communication of data in ongoing and completed studies
• Review regulatory documentation and other communications, including IND, IB, annual reports, CSR, abstracts, manuscripts and presentations
• Coordinate relationships with external key opinion leaders and investigators and lead/participate in investigator meetings, advisory boards and site visits.
• Work and partner with internal and external (CRO, investigator) stakeholders
• Adhere to and implement quality standards and SOPs in clinical development

Position Requirements:

• The successful candidate’s position and title will be commensurate with experience
• Bachelor’s degree with at least 5 years’ industry experience in oncology drug development
• Experience with small molecule therapeutics preferred
• Experience in Phase I protocol development and clinical strategy development is required
• Knowledge of the regulatory environment and experience with working with regulatory authorities is required
• Strong understanding of cancer biology and ability to integrate biological knowledge into clinical development strategy
• Additional experience in non-oncology therapeutic areas (Immunology) is a plus
• A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, results-oriented and dynamic environment
• Excellent interpersonal skills and a demonstrated ability to work well within team structure is essential
• Strong written and verbal communication skills.
• Ability to travel up to 20%