Vice President of Medical Affairs

We are seeking a Vice President of Medical Affairs who will provide strategic leadership to develop an integrated medical affairs strategy with a significant impact on the development and life cycle of development projects. The VP of Medical Affairs will work closely with senior management and cross functional partners. The VP will work closely with KOLs, scientific collaborators, and researchers for their valuable input. Core responsibilities will encompass developing and executing medical affairs strategy and supporting new product development as well as leading ad boards, scientific meetings, symposia, associated trainings, continued medical education (CME) activities, and launch prep. The role will report to the Chief Medical Officer and may be remote or based in our offices in Berkeley, California.

Responsibilities include:

Lead and create the global medical affairs strategy for all development projects, working closely with stakeholders and cross functional teams
Lead the creation and the execution of the following strategic plans for medical affairs:
Strategic and tactical plan
Publication plans
KOL and site management plan
Training plans
Drive international congress planning, strategically targeting relevant meetings and assuring data for development programs meets strategic objectives as aligned with senior management. Attend medical scientific meetings and congresses to represent the company
Lead publication strategy and planning for the clinical organization. Define publication timelines. Review all publications (abstracts, manuscripts, posters, presentations, etc.) and assure that they are consistent with the strategy as outlined in the publication plan
Identify, develop, and implement actions to achieve operational excellence and cost efficiency and cultivate long-term relationships with KOLs, scientific researchers, medical centers, and the cross functional Caribou team
Provide scientific input into business development activities. Identify potential drug candidates for licensing/acquisition, technology or partnership opportunities through their knowledge of the industry, interactions with KOLs, researchers and stakeholders
Provide robust and ongoing disease and product training as needed.
Contribute medical affairs strategy and deliverables to the Integrated Development Plan (IDP) for each asset in development
Assist with investigator and site selection activities for all clinical trials, lead secondary analyses of primary data (in collaboration with clinical) and research involving external databases
Maintain high level timelines and detailed timelines for all medical affairs deliverables. Effective, consistent, and regular tracking of project timelines to allow full transparency to the senior leadership
Assure that functional deliverables are completed on time, on budget, and according to the highest quality, ethical, and professional standards
Work closely with strategic partners
Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership
Prepare monthly progress reports and ad hoc reports as required
Assist in the initiation, oversight, and follow up of medical projects such as: post market clinical activities, registry projects, and epidemiological surveys. Ensure all such activities comply with applicable local regulations.
May directly manage a small team
Assure that the highest quality, ethical, and professional values are demonstrated in all aspects of the teamwork
Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations
Qualifications and Skills:

PhD/PharmD, or relevant advanced degree with 10+ years of experience in pharma or biotech drug development
Extensive knowledge of drug development and/or experience in more than one functional area such as clinical, med affairs, translational development, regulatory, commercial, safety, etc., to assure broad understanding of the pharmaceutical development
Prior cell therapy drug development experience is mandatory
Prior IND, NDA, or BLA filing/submission and launch experience
Good understanding of GCP, standards around HCP interactions, and strong expertise in the conduct of clinical trials in hematology/oncology and cell therapies
Knowledgeable of competitive products and their application
Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization.
Product lifecycle management experience highly preferred
Superior interpersonal skills and communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence
Highly collaborative and effective influencing skills and the ability to operate across multiple geographies
Strong track record of delivering results through effective team and peer leadership in matrix
Excellent leadership and organizational skills, analytical skills, presentation skills, and strong experience in translating medical/clinical information into medical affairs strategies
Caribou compensation and benefits include:

Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees
Generous paid vacation time, in addition to company-observed holidays and floating holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Tuition reimbursement program
Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Caribou requires employees to be fully vaccinated against COVID-19 unless they have an approved medical or religious accommodation. Proof of such vaccination will be required as part of the hiring process.

For more information about Caribou, visit www.cariboubio.com and follow the company @CaribouBio.

To apply for this job please visit boards.greenhouse.io.

Job Location