Clinton Allen Email & Phone Number

Hayward, California

A management consultancy with practices in compliance assurance, risk management, higher education administration and business general management. Clients served are primarily hospitals & HMOs, life sciences, biotechnology and pharmaceutical companies.

Lead regulatory strategy, product development, and strategic partnering for a start-up medical devices company.

Enterprise Risk Management. Led risk assessment and risk mitigation planning for business units to include Technical Operations (pharmaceutical/biotechnology) Medical Imaging, and Nutritional business units. Wrote command and control provisions of the company’s catastrophic event (pandemic) response and recovery plan.

Built and led the corporation’s regulatory compliance audit function. Defined the scope of the function and prioritized regulatory compliance areas of emphasis. Assessed existing internal audit capabilities for each business unit and international region, and identified options to complement existing audit groups by adding corporate oversight. Hired staff and engaged consultants to further establish the compliance audit function. Audit function was an integral component of a seven part Office of the Inspector General (OIG) pharmaceutical compliance program (“monitoring and auditing”). Areas of audit included FCPA, government pricing, aggregate spend, fee-for-service arrangement, and HIPAA.

Project Management. Tracked project status and briefed senior leadership on issues regarding development and commercialization of multiple products. Coached commercialization team leaders in project management and the process of drug commercialization.External Manufacturing. Led the “Third Party” manufacturing initiative to improve quality. Prepared quality agreement templates for use with external manufacturers of bulk active pharmaceutical ingredients and finished pharmaceutical products.Guidance and Optimization. Supported multifunctional teams responsible for technology transfer, scale up for commercial manufacture, long term stability studies, and process validation activities in preparation for regulatory filings. Conducted “lessons learned” sessions and disseminated knowledge across the manufacturing organization.

In-licensing and Acquisitions Due Diligence. Led teams examining manufacturing aspects of acquisition and in-licensing candidates.Divestitures/Out-licensing. Technical due diligence lead for divestitures. Presented to buyers, reviewed terms, and advised deal makers regarding advantages and valuation.New Business Integration. Reviewed acquired organizations’ manufacturing supply agreements for integration into the external manufacturing network. Analyzed options for physical and financial flows for products in the post acquisition integration phase. Technology Transfer. Managed international projects to transfer production between sites, or to third party manufacturing. Co-led technology transfer projects for divested products with new owners.

Corporate EHS Programs. Developed and implemented corporate programs such as ISO 14001 certification, waste water systems upgrades, safety performance measurement and awards, and safety training (US, Italy). Environmental Assessments. Conducted Phase I and Phase II environmental assessments.Environmental, Health, and Safety Audits. Led EHS compliance audits in pharmaceutical, nutritional products, consumer products and medical devices manufacturing facilities around the world. ISO 14001 Certifications. Led achievement of the company’s first four certifications to the ISO 14001 Environmental Management Systems Standard.Sustainable Investment Funds Liaison. Representative to environmentally responsible and sustainability investment groups. External Relations. Representative to external environmental stakeholders including non-governmental organizations and universities.

Program Leadership. Led the 140 student Minority Engineering Program at San Francisco State University. Recruited, retained and graduated students of African, Hispanic, and Native American Indian heritage.Grant Writing & Administration. Chaired an Industry Advisory Board responsible for generating and disbursing $40,000 in student scholarships annually. Increased endowment for MEP by $120,000.Strategic Partnering. Worked with community colleges to identify and support high potential transfer students.Teaching. Developed and taught an introductory engineering course (ENGR 1111) as an adjunct professor. Academic Support. Advised student professional societies and administered a study center with tutoring programs.

In positions ranging from Cadet at West Point to Captain of Air Defense Artillery:•Leadership. Led soldiers in all aspects of war preparedness. •Multiple Systems. Employed the Vulcan cannon, the Chaparral missile, and the Stinger missile with the 3d Infantry Division.•Personnel Development. Designed accession ladder (promotions and training by occupational specialty) for enlisted Air Defenders.•Community Affairs. Served as Battalion liaison officer to German partner air defense Regiment and local community.

Ms, Environmental Management & Science

Environmental Management & Sciences Fellow, the National Urban Fellows organization.

Bs, Engineering Studies

Activities and Societies: German Club, Gospel Choir