About the position:
Enliven is dedicated to advancing small molecule drug development programs in oncology. The Associate Director, Clinical Operations will independently manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. Manages all aspects of clinical operations for assigned project(s). This includes contributing to the strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities. Works with Vice President, Clinical Operations to establish and approve with CRO scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May also have responsibility in the areas of training, labeling, package design adherence to protocols. Interacts with various inside/outside groups to facilitate clinical programs. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts. This position will report to Vice President, Clinical Operations.
- Leads the execution of clinical studie(s) to support the Clinical Development Plan (CDP)
- Contributes to the development, management, and execution of the CDP which includes timelines, budget, and resource requirements.
- Contributes to the development and implementation of the clinical program strategy and manages those systems and programs in order to meet Company goals and objectives.
- Provides strategic input into the CDP. Identifies program/resource gaps and proposes solutions.
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgments within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Ensures budgets, schedules and performance requirements are met.
- Ensures that Clinical Operations department functions effectively internally. Helps build and develop internal processes and systems.
- Proposes innovative ideas to help resolve challenges faced by the project team.
- Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs.
- Manages internal staffing and performance management, including hiring, training, coaching and performance reviews. Mentors and develops clinical operations staff.
- Bachelors/Masters degree in a scientific discipline is required. Equivalent experience may be accepted.
- 10+ years pharmaceutical development experience with at least 4 years managing CROs is required.
- Must possess excellent project management and strong interpersonal skills
- Proven track record of being a strategic thinker and a tactical implementer.
- Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast-learner and works well in an organization that places a high value on intellectual capacity.
- Excellent written and oral communication skills.
- Working knowledge of FDA & ICH/GCP regulations and guidelines
- Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint.
- Comfortable in an entrepreneurial organization wherein the environment is fast-paced and challenging.
Interested applicants, please send resume to: firstname.lastname@example.org
Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.
Enliven Therapeutics does not accept resumes from recruitment agencies for this position. Recruiters, please do not send resumes to Enliven employees or to the company location. Enliven is not responsible for any fees related to unsolicited resumes.