The Pharmacology/Toxicology Director at Biologics Consulting (Biologics) will directly manage and provide oversight of Consultants and Sr. Consultants within the non-clinical team as well as serve as a regulatory consultant for regulated industry client companies. This role is expected to be approximately 65% supervisory and team leadership responsibilities and 35% billable/consulting responsibilities. Reporting directly to the COO, the Director of the pharmacology-toxicology team will be a subject matter expert (SME) in regulatory pharmacology/toxicology and will directly supervise/line manage non-clinical team members.
In the team lead role, responsibilities will include supervising/line management of regulatory consultants, supporting opportunity and resource allocation to ensure that team members are fully utilized, providing knowledge, experience, motivation, business development support and direction on achieving Company and group goals. The incumbent will lead by example and foster a team environment, ensuring an overall ‘culture of quality’ in the execution of services provided to clients. The Director is responsible for driving performance, goal attainment and growth strategies. This position requires a balance of client/opportunity oversight, quality management and people management, along with developing strategic business development and marketing plans with support of non-clinical team members in line with the growth objectives of the Company as defined by Management (65% of time).
Billable/consulting duties will include serving as an expert in regulatory pharmacology/ toxicology and providing direct consultation with biopharmaceutical companies to advise them on the best pharmacology/toxicology approaches that will expedite product development and through marketing authorization (35% of time). Responsibilities include, but are not limited to, planning appropriate pharmacology-toxicology studies, identifying and interfacing with relevant CROs, preparation for and participation in FDA meetings, evaluation of toxicology data, and reviewing and/or writing regulatory documents (e.g. pre-IND briefing packages, IND, BLA/NDA).
The incumbent should have a Ph.D. (preferably in pharmacology or toxicology) with at least 7 or more years of experience within industry, consulting, CRO or a national regulatory agency such as the Food and Drug Administration, as well as having experience with a broad base of products (small molecules, vaccines, monoclonal antibodies, therapeutic proteins, blood products, and cell and gene therapies), and have excellent verbal and written communication skills. Experience and strong people management skills are requirements for this role.
Anticipated travel requirements for the position will be approximately 20%. This is a ‘remote work’ position however, the incumbent will be required to travel to Alexandria, VA headquarters periodically for meetings with Management. As a member of the Senior Leadership Team (SLT), the Director will attend two 1-hour meetings per month (biweekly) with the Biologics SLT. Additionally, the Director is required to convene regular meetings with their Specialty Team.
Duties and Responsibilities: To include the following and other duties identified and assigned.
Provide senior leadership to pharmacology-toxicology team while creating a strategy and action plans to accomplish corporate and team goals
Supervise, develop performance objectives and professional development plans, coach & mentor and provide performance reviews for all team members
Lead the team to attainment of revenue targets and operational goals
Develop strategy and implement action plan for the team to reach its target business goals, including identification of hiring needs and recruitment of staff consultants
Establish system of triage to distribute client projects throughout the team in a manner that is transparent and focused on identifying the best technical fit for the project
Host regularly scheduled team conference calls/meetings, assess and collect project status updates, discuss client opportunities
Work with other team leads to facilitate the timely identification of resources required to support multidisciplinary projects where appropriate
Manage the overall budget for the team and provide periodic updates to Sr Management
Review and assess resource and talent requirements within the team in line with growth objectives and provide recruitment/hire recommendations to the COO
Support development of an on-boarding plan for new hires
In collaboration with the BD Director, COO, and CEO and other Group Leads, identify and support business development best practices to optimize growth of the Company
Cascade leadership direction from Sr. Management, reinforce operational processes, assess and share opportunities/issues and convey feedback from group members to Biologics Management
Contribute to the Senior Leadership Team (SLT) and participate in conference calls with Biologics Consulting Management
Share best practices, assist in annual strategic planning workshops, identify and recognize stellar performance/accomplishments
Display leadership ability including ability to create a positive and collegial culture and motivate the non-clinical team to perform effectively
Serve as a positive, energetic, forward-looking leader for the team
Graduate degree (Ph.D minimally) in a scientific discipline from an accredited institution required; board certification desirable
Seven (7) or more years of relevant experience in regulated product environment with FDA or within industry, consulting or CRO; recognition as an expert in the field of expertise
Five (5) or more years of leadership, people management experience with a proven track record of performance and business success (i.e. goal and revenue attainment)
Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent oral and written communication skills, team player, organized analytical thinker with a high level of energy and self-motivation
Demonstrated versatility in conflict resolution, problem solving, and working effectively as a part of a cross functional organization.
Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-nine years since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients internationally to address nonclinical, clinical, product development and manufacturing, and regulatory compliance challenges.