Job Title: Medical Director, Clinical Development
Position Code: 2100171002
Location: Peloton Therapeutics, Inc.
Education: M.D. with Board Certification or Board Eligibility
Career Level: 3+ years Pharmaceutical and/or Biotechnology Experience
Date Needed: November 2017
Job Type: Full-time/Exempt
Travel: 25 percent (Domestic and International)
Peloton is dedicated to developing first-in-class, highly effective medicines for life-threatening diseases by leveraging great science, talented employees, and productive collaborations. We are seeking high-caliber individuals to join our growing team and contribute to our culture of collaboration, innovation, excellence, and shared sense of purpose. If you are passionate about improving patient outcomes, are driven to be the best at what you do, and are ready to make a positive impact, we invite you to apply to join our team. We offer an attractive compensation package including company ownership, competitive salary, comprehensive benefits, and the opportunity to be part of a dynamic biotech environment.
This is an exciting opportunity for a highly motivated individual to ensure the medical and scientific integrity of clinical studies and the well-being of patients. The successful candidate will be responsible for effective medical/scientific oversight of studies along with support of core drug development efforts to impact the treatment of human disease.
- Execute clinical trial plans to deliver compelling safety, pharmacokinetic, and efficacy data supportive of regulatory applications
- Contribute to company scientific and clinical strategy by setting appropriate clinical objectives and priorities
- Implement and oversee all aspects of clinical trial conduct including regular physician calls, data reviews, etc.
- 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 sites, and services to support clinical development of investigational agents (central laboratory, biostatistics, etc.)
- Serve as primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of the protocol
- Lead the analysis and interpretation of clinical trial data and the reporting of clinical trial results
- 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.)
- M.D. with board certification or board eligibility
- Minimum 3 years of pharmaceutical and/or biotechnology experience in medical monitoring of clinical trials; previous oncology experience preferred
- Knowledge of regulatory guidance for the conduct of human clinical trials
- Strong organizational, problem-solving, and priority management skills
- Excellent interpersonal and communication skills (both written and oral)
Hires Needed: 1
Wage Amount: Based on Experience
Company Contact: firstname.lastname@example.org
Notice to Recruiters:
Peloton Therapeutics’ Human Resources Department manages the recruitment and employment process for the company, and all candidates must be presented through this Department according to Peloton’s vendor policies. If your agency wishes to establish a relationship with Peloton Therapeutics, you must work directly with the Human Resources Department. Contacting our hiring managers or employees directly is not appropriate. For more details, please email email@example.com. For the protection of all parties involved, Peloton will only accept resumes from recruiters if an executed agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Peloton from recruiters do not constitute any type of relationship between the recruiter and Peloton and do not obligate Peloton to pay fees should we hire from those resumes.