Head of Business Development
The Head of Business Development will be responsible for activities supporting the in-licensing of products and/or companies, the out-licensing or partnering of BDSI products to companies both within and outside the U.S., and co-promotions. The position will support the future growth of BDSI through product/company acquisitions and securing of external commercial and/or development partners or co-promotion partners when needed. It will include seeking out opportunities, providing a thorough analysis and marketing research to support decision making, and executing the licensing process. Strong analytical skills and experience in the pharmaceutical industry is necessary, as well as the ability to work closely with cross functional teams internally and external partner candidates. Experience in Business Development and a past history of successful business development transactions in pharmaceuticals are critical. The position will work closely with BDSI Senior Management as well as R&D, Clinical, Regulatory, Legal, Finance and Commercial functions in the assessment and decision making process, conduct of due diligence and execution of agreements. The position will report to the Senior Vice President, Corporate and Business Development.
Serves as a key point of contact within BDSI for potential licensing, acquisition, collaborations, and co-promotion agreements.
Leads efforts in the search, evaluation, due diligence and execution of business development opportunities.
Coordinates and manages the assessment and review process for all opportunities identified including data analysis, marketing research when needed, and forecasting.
Works closely with R&D, Clinical, Regulatory, Legal, Commercial and Finance to ensure deals are being advanced and executed.
Responsible for the quality of the formal due diligence output, integrating internal and external subject matter, and expert input for senior management review and approval.
Assures appropriate deal structure, terms, financial models and value creation.
Proposes measures to improve internal processes to assure optimal evaluation of potential targets and opportunities.
Good understanding of industry trends and competitive landscape, ideally with some experience in the pain, addiction and CNS area.
Strong business acumen and ability to translate scientific and technical information to identify attractive business opportunities.
Strong interpersonal, analytical, critical-thinking, verbal and written communication skills.
Strong leadership skills and proven ability to influence others to reach common goals as well as act independently.
Adaptable to change and a willingness to contribute to the overall business as needed.
Demonstrated ability to manage resources and find creative means to gather the information needed to support decision making.
Solid negotiation skills.
BA or BS required, MBA preferred
Minimum 8-10 years of experience working for a pharmaceutical/biotech company in business development, licensing, or strategic analysis capacities or experience working for a consulting firm or investment bank focused on the pharmaceutical/biotech markets with additional pharmaceutical/biotech industry experience.
Track record of successfully executing deals from start-to-finish within prior biotech/pharma positions.
Possess superior analytical, strategic and communication skills. Well organized and detail oriented. Advanced knowledge of data and custom research methodologies to support decision making.
Analytical reasoning abilities, strong business acumen, and creativity in problem solving.
Strong verbal and written communication skills as well as presentation skills with the ability to interact effectively with/present to (verbally and in writing) all levels of the organization.
Ability to manage multiple projects and meet required deadlines.
Director, Pre-Clinical Development
Lead BioDelivery Sciences’ preclinical program on its pipeline product. The position reports to the SVP and Chief Technology Officer. The position will provide scientific leadership and play a pivotal role in developing the nonclinical strategy. He/she will design, implement, interpret and report data from nonclinical and toxicology, toxicokinetic, histopathology studies for its pipeline products.
The individual will engage with the CMC and regulatory team for formulation selection and conduct critical GLP studies for a successful IND submission. The individual will be an accomplished nonclinical development scientist with a proven track record of significant contributions to project goals and problem solving. Serves as a toxicology subject matter expert providing project support including developing program nonclinical strategies and reporting key program nonclinical milestones and timelines to project teams.
Work with cross-functional partners to establish project success criteria, monitor project progress, and communicate information to management. Function as study monitor for preclinical studies at contract laboratories by designing, monitoring and overseeing reporting of studies conducted by CROs. Summarize, analyze and interpret study results and communicate information to project teams and management.
The core responsibilities of this position include development and execution of nonclinical drug development strategies, as well as design and oversight of outsourced nonclinical studies (toxicology, safety pharmacology, and DMPK assessments) conducted at a Contract Research Organizations (CROs).
The candidate must have direct experience designing, managing and reporting results from toxicology and other safety studies, managing external CROs, and drafting nonclinical sections for regulatory submission. This individual must work collaboratively with internal and external cross-functional teams, collaborators, CROs and consultants to map complete development pathways for each drug candidate.
A PhD or equivalent in toxicology. Minimum of 10 years of experience in a pharmaceutical industry including at least 7 years of experience in managing scientists. Worked in a R&D organization including Quality, Compliance, Manufacturing, Product Development, and Regulatory Affairs. Deep understanding of in vitro and in vivo pharmacology models. Understanding of critical issues in drug discovery and development. Working knowledge of FDA guidelines for therapeutics development. Demonstrated ability to prioritize and clearly articulate research objectives. An innovative attitude coupled with a strong sense of practical execution. Strong record of mentoring and enabling career development. Must have the ability to work collaboratively as part of a team in a fast-paced dynamic environment. Excellent interpersonal skills with the ability to inspire subordinates, peers, and superiors. Ability to travel (10%).