Senior Medical Director Clinical Development Job Description Template
Our company is looking for a Senior Medical Director Clinical Development to join our team.
Responsibilities:
- Evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies;
- Lead clinical study teams and provide appropriate medical monitoring for ongoing clinical studies;
- Development of clinical protocols and amendments, investigator brochures, and clinical study reports;
- Prepare manuscripts, abstracts and presentations for scientific meetings and advisory boards;
- Oversee tucatinib development broadly within a specific indication or group of indications;
- Serve on the tucatinib Global Development Team and contribute to strategic development of tucatinib clinical programs broadly;
- Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates;
- Conduct literature reviews and prepare summaries to support clinical development programs;
- Advise on current and future clinical development plans within internal and joint development teams;
- Develop manuscripts, abstracts and presentations for scientific meetings;
- Establish and drive teams to execute the strategic long-term vision for the program;
- Lead development and maintenance of clinical documents (e.g. protocols and amendments, investigator brochures, clinical study reports);
- Conduct literature reviews and prepare summaries to support clinical development strategies;
- Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies to inform clinical strategy;
- Lead clinical study teams and ensure appropriate medical monitoring for ongoing clinical studies.
Requirements:
- Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders;
- Demonstrates a passion for helping patients with cancer and for the science of oncology;
- Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies;
- Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals;
- Clinical oncology experience; Board certification in oncology with experience in genitourinary malignancies is preferred;
- 3-5 years industry experience in oncology drug development;
- Excellent oral and written communication skills;
- MD or MD/PhD;
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate;
- Is a team player, works well in a team environment both as a leader and a key contributor;
- Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s).