Radius Health is searching for a Head of Pharmaceutical Science/Development, Tech Ops. with sound technical and leadership capabilities to develop our promising pipeline and support our commercial products. Reporting to the Senior VP of Technical Operation and a member of the Technical Operations Leadership Team, this role is accountable for leading and developing a high performance team responsible for developing early stage, late stage, and supporting commercial manufacturing to help our osteoporosis and oncology franchises bring innovative therapies to patients. The individual will have a well-established track record of successful leadership and will be responsible for establishing a clearly defined vision and objectives for the team aligned with company objectives. They also need to have a broad range of knowledge across the various functional areas in pharmaceutical development, understand manufacturing technologies, and people/organizational structures. The role enables high-performing internal and external development teams to successfully develop, commercialize, and file products. In addition, this role will oversee the development of peptides, small molecules, injectables, solid dosage form, and transdermal devices with associated analytical methods. Key responsibilities include leading and managing the pharmaceutical development staff, developing project strategies across various programs for drug substance, drug product, and analytical methods, building effective relationships with cross functional management and external partners, providing guidance for resolving technical challenges including commercial manufacturing, and providing guidance for regulatory filings.
Participate as an active member of the Technical Operations leadership management team, ensuring achievement of overall Tech Ops goals.
Build relationships and ensure alignment with cross functional management including Supply Chain, Quality, Regulatory, Business partners, and External contract organizations
Build development strategies and priorities aligned with company goals across programs and manage budgets. Develop strategies based on risk management principles for fast tracked submissions.
Responsible for monitoring project performance, short-term and long-term goals, pro-actively providing the head of Technical Operations and the Technical Operations leadership team with regular updates and solutions
Manage operational procedures within area of responsibility. Maintain and enhance the functional excellence of Pharmaceutical Development organization
Enable the team in meeting project relevant milestones and ensure activities are meeting overall project time-lines
Provide guidance and participate in evaluating licensing and due diligence opportunities.
Lead and participate in strategic initiatives for improving functional process
Ensure teams are documenting development activities to support submission and are scientifically valid
Manage development staff and align goals and objectives of staff with company objectives
Lead staff in providing options, and recommending solutions for technical challenges
Maintain an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry
Review and approve regulatory documents, submissions, and responses
PhD. in Pharmaceutical Sciences or related discipline with at least 15 years of relevant experience in pharmaceutical development and validation is required
Experience in successfully leading and managing pharmaceutical development groups through various stages of development within a cross functional organization is required
Demonstrated ability to prioritize and align departmental objectives with company goals and objectives
Ability to build effective networks internally and externally
Must have experience in successfully overseeing vendors and building technical relationships with business partners
Knowledge of current regulatory guidance’s and experience in managing IND and NDA filings is required for this role.
Excellent interpersonal, technical writing, and oral communication skills.
Essential Leadership Capabilities:
The ability to make decisions, set priorities and share resources based on what will benefit the whole
Capable of building and maintaining networks within and outside of the organization
Able to navigate ambiguity by demonstrating reasoned risk taking. Lead others through change by providing context and engaging individuals.
Capable of building legitimacy through cultivating honest relationships and an environment of openness
Ability to proactively develop talent across the organization and engage external talent aligned with organizational priorities
The work is performed in a typical office environment with heavy computer duties. The noise level in the work environment is usually quiet. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.