Senior Director - Pharmacology / Toxicology
Research Triangle, NC, USA | Asklepios Biopharmaceutical
Industry:Pharmaceutical / Biotech
Job Description:81 people have viewed this job
The Senior Director, Pharmacology/Toxicology will serve as a key scientist and manager for developing and executing preclinical and clinical strategies to support AskBio’s pipeline of gene therapy products.
Under the direction of the VP of Translational Medicine, (and indirectly the SVP of Translational Medicine) this individual will coordinate and manage various research, proof-of-concept and formal non-clinical studies leading to filings of pre-IND packages, INDs and eventually BLAs for a broad array of projects in clinical development. As a key member of various project teams, the Sr. Director of Pharmacology/Toxicology is expected to be a content specialist in matters of pharmacology and toxicology with a keen understanding of clinical development and regulatory strategy in the gene therapy field and have a working knowledge of OTAT guidance’s and policies.
In this startup environment this position requires flexibility and the ability to work across traditional boundaries and sometimes outside of one’s comfort zone (i.e., contributing in areas outside of one’s expertise). A portion of work in this position will include supporting development of clinical protocols and developing strategies for incorporating non-clinical findings/model data into the choice of clinical endpoints and inclusion/exclusion criteria.
The ability to respond quickly to a rapidly changing environment of new projects and strategy changes is a must for this position. AskBio is a pioneering gene therapy company, and change is inherent in the company’s business model. The incumbent of this position must therefore be mentally agile and accommodating to unconventional strategies and willing to contribute input on short notice. Business development with external groups such as academic or industry partners and vendors (CROs, central laboratories, etc.) is a key to our success – managing these relations is also an integral part of this position. Working from within Translational Medicine, this individual is expected to work closely with cross functional groups within the company and with external partners to meet project and company goals and objectives.
Responsibilities and Accountabilities
• Across programs, this position oversees and manages AskBio’s preclinical portfolio of studies for POC, pre-IND and IND submissions and eventually for BLA submissions
• On project teams provides pharmacology and toxicology expertise and consultancy for preclinical and clinical submissions in support of regulatory filings
• Overall responsibility for developing protocols, aligning resources and managing the conduct of preclinical studies performed in house or at CROs
• Supervises a team of preclinical scientists and technicians in the conduct of preclinical studies supporting exploratory indications, early stage POC and later stage indications in clinical development
• In concert with project teams, FDA feedback, CROs and collaborating Veterinary pathologists, develop protocols and monitor GLP toxicology studies suitable for IND filings and other regulatory submissions
• Provides pharmacology/toxicology expertise to clinical development efforts (team discussions, program queries, interaction with KOLs, disagreements, etc.), as appropriate
• Provides pharmacological insight (disease mechanisms, pharmacokinetics, protein targeting, etc) to R&D and Translational Medicine and clinical teams in development of new capsid and cassettes with the aim of providing the most effective vectors and streamlined strategies
• Coordinates pharmacology/toxicology goals and activities with other translational medicine disciplines (product design, analytical, assays, clinical development, clinical operations) to ensure efficient, timely and harmonious achievement of program goals
• Develops an external network of professional support conversant with gene therapy development and able to provide independent expertise in pharmacology, toxicology, preclinical and clinical development
• Provides program and project teams with relevant scientific, pharmacology, toxicology and gene therapy development expertise as appropriate in team and individual settings
• Coordinates activities with the VP and SVP of Translational Medicine, and with the CSO, CMO and VP of Clinical operations, as appropriate
Minimum of PhD in life science discipline (i.e., biology, molecular biology, biochemistry, medicinal chemistry), DABT or equivalent expected, with at least 12 years of drug discovery/drug development experience
In-depth knowledge and first-hand experience of the regulatory environment (US & Europe) for drug development (preclinical and clinical), preferably in the gene therapy field
Hands-on experience in cell biology, pharmacology, preclinical or clinical studies and techniques supporting gene therapies through various stages of product design, preclinical POC, preclinical and clinical development
Strong scientific writing skills and experience in preparation, strategy, design, writing and editing of regulatory documents (pre-IND packages, INDs, BLAs, etc) and ability to work with Regulatory in meeting timelines
Strong interpersonal skills and proven ability to work effectively in a multidisciplinary team environment
Evidence of leadership skills, people development, and ability to influence stakeholders in strategies pertaining to preclinical and clinical development
More about you:
Broad understanding of the regulatory process including CMC, non-clinical and clinical and the various stages of stages of clinical development of gene therapy products
Hands on experience and intimate knowledge of the day-to-day operation of an R&D organization
Demonstrated ability to manage multiple and diverse programs/projects concurrently.
Demonstrated ability to develop relationships and generate collaborations
Strong analytical skills; a strategic thinker, planner and implementer; proven negotiating track record. Proven leadership and management background, including strategic and analytical thinking, vision, market differentiation and business results required
Solid scientific writing skills with appropriate scientific knowledge to enable designing authoring and editing study documents and regulatory submissions
Ability to operate independently with minimal management support
Documented history of scientific output in the form of refereed publications and regulatory documents
Excellent written and oral communication skills and fluency in English
Organizational and cross functional collaboration skills
Some domestic and international travel is expected and required
Proficient in Microsoft Office (i.e., Word, Excel, SharePoint and PowerPoint). Experience with global teams, especially Spanish speaking, a plus
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