- 200 Cambridgepark Dr, Cambridge, MA 02140, USA
Together with our elite cancer immuno-therapy scientists, you will be a part of our Drug Discovery teams leading projects to apply our ACTR (Antibody Coupled T cell Receptor) technology against different cancer indications. Our teams work from early discovery through launching programs into clinical development, offering you a great experience across the stages of invention. Our nimble and interdisciplinary approach to research can help you learn how to use creativity, cooperation, and critical thinking to solve hard problems. You’ll get to know scientists following diverse career paths and see for yourself how the extraordinary successes of immune therapies are creating new chances to help cancer patients.
This is a unique opportunity to play a key role in drug development at an early-stage biotech company with innovative science, dedicated colleagues, and strong leadership. This position will be a leader in the research and development organization and will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures. Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment.
For the Senior/Medical Director role, we are looking for a biotech/pharma industry experienced medical hematologist/oncologist to provide medical and clinical scientific leadership for our development programs, where we are combining our distinct genetically-modified autologous T cell platform with therapeutic antibodies across a range of oncology indications.
You will provide medical oversight and clinical development leadership for Unum’s clinical programs in cancer immunotherapy, with a focus on our hematologic oncology indications, and will actively participate in Unum’s research, translational science, and business development activities in support of the portfolio. Working on cross-functional multidisciplinary product teams, and leading clinical development sub teams, you will drive the development strategy, the design of clinical trials, and take accountability for the execution of the clinical development plan in support of the overall asset strategy. Primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation is expected, potentially in collaboration with and supported by a clinical scientist. It is anticipated that over time, managerial responsibilities within the clinical science function may be required, in addition to your expected leadership roles on program teams.
What will you be doing?
Reporting directly to the Chief Medical Officer, you will be focused on the following activities:
- Working with Unum research teams, you will provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives as required;
- You will provide medical and drug development analysis, critique, and interpretation of business development due diligence initiatives as required;
- You will join specifically identified product (i.e. asset) teams as the clinical science leader. In this role, you will participate in all aspects of the overall product (i.e. asset) strategy, drive the clinical development strategy, and assume primary accountability for all aspects of the design and execution of that strategy;
- You will provide medical monitor oversight, including oversight of trial subject safety and clinical data review and interpretation, for programs to which you are accountable;
- As medical lead on your respective product teams, you will oversee the writing of all critical program documents pertaining to the asset’s development, including but not restricted to study protocols, the investigators’ brochure, regulatory filings and submissions, abstracts, manuscripts and publications, clinical study reports, etc.;
- As medical lead on your respective product teams, you will provide scientific, clinical development and medical input into all other program documents in support of the development plan, including but not limited to informed consent forms (ICF), case report forms (CRF), statistical analysis plans (SAP), and clinical pharmacology/translational medicine plans (CPAP), etc.;
- As a leader of cross-functional teams, you will work with other team members in a collaborative manner to achieve efficient, cost effective, and high-quality design and execution of the clinical development plan, both with internal Unum team members, external consultants and CROs, as well as study investigators, DSMCs, and other critical program stakeholders.
- MD with 2-8 years of experience in clinical trial design, development, and execution for oncology products required (level/title of position TBD based on candidate experience); immune-oncology therapeutics, and/or cell or gene therapy platform experience preferred but not required;
- Board certification/eligibility in medical oncology and/or hematology strongly preferred; board certification in other internal medicine subspecialties, with specific work experience in oncology research and development within biopharma is acceptable;
- A comprehensive understanding of applicable US, EU, or other independent health authority regulatory requirements is required, as is a deep working knowledge of the drug development process;
- A working knowledge of biostatistics, data management, clinical operations, translational sciences, clinical pharmacokinetic scientific and other technical disciplines and processes intimate with the drug development process is required;
- Direct managerial experience within biopharma for at least 2 years is strongly preferred, but not required;
- Outstanding communication skills (written and verbal, both formal and informal) are an absolute requirement;
- Ability to manage multiple projects and initiatives simultaneously in a fast-paced environment is required;
- Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams is absolutely required.
All your information will be kept confidential according to EEO guidelines.