Job Description
Medical Director
Job Description
Jacobio Pharmaceuticals is a clinical stage biotech company dedicated to the development of innovative drugs for unmet medical needs. The vision and mission of Jacobio is to become a global leader providing revolutionary therapies for patients with serious and life-threatening diseases such as cancer, autoimmune and infectious diseases. For our new site in greater Boston, we are seeking energetic and self-motivated physicians at various levels to join our team to work toward translating novel anti-cancer therapies into clinical space. The successful candidate is expected to have clinical research experience in oncology with first-in-human trial experience preferred. The applicant is expected to have in-depth knowledge in biology of cancer, anti-cancer therapies and experience in oncology trials. In addition, the applicant has to have intellect curiosity, passion toward cancer patients and collaborative spirit. Description of Responsibilities:
- Develop and implement clinical development strategies/plans for novel drug candidates in oncology and non- oncology indications as part of a cross-functional project team, leading discussions, and revisions of study design with internal stakeholders and external experts/consultants.
- Work closely with project teams and the Translational Biology group to identify preferred therapeutic directions and patient selection strategies.
- Develop a deep understanding of the clinical and competitive environment and work with teams to develop target product profiles for projects in both research and development.
- Serve as the medical lead 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 high-quality cleaning, analysis, interpretation, and communication of data in ongoing and completed studies.
- Co-author regulatory documentation and other communications, including IND, IB, annual reports, CSR, abstracts, manuscripts, and presentations.
- Participate in regulatory authority interactions, as necessary.
- Develop productive 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.
Minimum Education/Skills Required:
- MD or MD/PhD with at least 3 years’ experience in drug development.
- Sub-specialty training or board certification in oncology, hematology or immunology preferred.
- Experience in Phase I protocol development and clinical strategy development is required.
- Industry experience is strongly preferred, although academic candidates with significant relevant experience in clinical trials and strategic development will also be considered.
- Knowledge of the regulatory environment and experience with working with regulatory authorities is preferred.
- Strong ability to integrate biological knowledge into clinical development strategy.
- 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.