San Diego, CA, US
$300,000 - $350,000
5 months ago
Location:San Diego, CA, US
Department: Clinical Development
Employment Type: Full Time
Hamlyn Williams is currently partnered up with a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies.
The company’s lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment.
We are in search of a Senior Director of Clinical Development who will drive the clinical development of portfolio products for the company. This person will be responsible for effective medical and scientific oversight of clinical studies and support core drug development efforts. This is a medical and scientific position with a broad range of duties, including designing and implementing high-quality clinical trials, actively analyzing data across disciplines and advancing company goals through actively contributing to scientific and clinical strategy.
This Senior Medical Director, Oncology Candidate will be the clinical lead of TransCon IL-2bg, providing critical input for first-in-human protocol development along with medical monitoring, regulatory interactions, safety assessments, and engagement with key opinion leaders and investigators.
The position will report directly to the Head of Clinical Development, Oncology.
- Drive execution of clinical trial plans to deliver compelling safety, pharmacokinetic, and efficacy data supportive of regulatory and marketing proof-of relevance
- Contribute to company scientific and clinical strategy by setting appropriate clinical objectives and priorities
- Implement and oversee all aspects of clinical trial conduct (regular physician calls, review of safety data, etc.)
- Closely collaborate with the clinical operations team/study team to ensure the integrity of medical and scientific aspects during clinical study execution, analysis, and reporting
- Work with clinical operations/study team to select and manage CROS’ study sties, and supporting services (central laboratory, biostatistics, etc.) to support clinical development of investigational agents
- Primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of the protocol.
- Lead in the analysis and interpretation of clinical trial data and the reporting of clinical trial results
- Adhere to critical timelines and direct the activities of team members, collaborators, clinical sites, and clinical investigators to meet required deadlines and target goals
- Develop, write, and review clinical protocols and Investigator’s Brochures.
- Collaborate with the research team and external investigators to expand or refine target patient populations.
- Contribute to regulatory strategy and the preparation of clinical sections for all regulatory filings (IND, Annual reports, AE/SAE reporting, study reports, etc.
- Crafting, reviewing, and approving clinical reports and presentations for internal and/or external purposes
- Partner with the preclinical development team to shape and define the development strategy for early assets.
- MD. or MD/PhD with board certification
- 3+ years of pharmaceutical and/or biotechnology experience in medical monitoring of clinical trials, oncology experience required
- Knowledge of regulatory guidance for the conduct of human clinical trials in the U.S. (FDA) and EU (EMA)
- Excellent interpersonal and communication skills with the ability to relate to both internal and external stakeholders, develop a strong positive relationship with senior management, and provide leadership and guidance to the high functioning clinical and regulatory team.
- Experience presenting to a wide variety of audiences including internal teams, and medical and scientific communities.
EEO & Employment Eligibility
This company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.The company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. is an E-Verify employer