Associate Director of Clinical Development, Oncology
Clinical Development | Berkeley, CA | Full Time
Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company utilizes its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage compounds in a number of therapeutic areas. Plexxikon’s most advanced program, Zelboraf™ (vemurafenib) was the first oral targeted therapy to be approved for the treatment of both metastatic and unresectable melanomas. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and to create significant value for Plexxikon, Daiichi Sankyo and patients.
Plexxikon's novel discovery approach, combined with experienced management and scientific teams, a broad network of scientific and clinical experts, and partnerships supporting later stage development, have been key drivers of the company's success since it began operations in 2001. Plexxikon is a small business with approximately 70 employees based in Berkeley, California and this position will be a critical member of the Development team reporting directly to the Vice President, Oncology. This is an exceptional opportunity to gain experience in a successful biotech company. The Associate Director of Oncology provides medical monitoring to multiple clinical trials. Additionally, the Associate Director leads the project teams in implementing clinical studies at high quality and in a time- and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines.
Position Requirements & Experience:
- M.D. degree required with preference towards board certification/specialization in Oncology (PhD or PharmD considered with significant clinical experience)
- At least 3 years of relevant drug development/clinical trial experience, either within industry or as a clinical investigator
- Experience and familiarity in pharmacovigilance as it applies to medical monitoring of clinical trials
- Experience and familiarity in writing protocols and investigator brochures, Development plans, preparation of meeting abstracts/posters, and reviewing clinical trial documents
- Experience and familiarity with monitoring and reviewing of incoming clinical trial data
- Experience with regulatory documents and interaction with regulatory authorities
- Experience and familiarity with analysis, presentation, and interpretation of ongoing clinical trial data
- Capable of conducting investigator meetings and leading site initiation visits with clinical trial investigators
- Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept studies
- Knowledge of running oncology clinical trials a plus
- Demonstrated ability to execute and deploy drug development strategic plans, to develop contingency plans, to provide technical and strategic advice, and to meet milestones and budgets.
- Strategic leadership and tactical skills, excellent initiative and judgment, and the demonstrated ability to positively represent the goals of Plexxikon
- Ability to interact with biologist and applying translational medicine aspects going into the clinic and taking learning form the clinic back to the lab
- Ability to interact with clinical investigators and thought leaders
- Ability to work in a cross functional team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
- Understanding of regulatory and other ethical guidelines relevant to the pharmaceutical industry, and the ability to ensure compliance with these external guidelines
- Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
- Creative thought processes and problem solving ability
- Ability to function with minimal direct supervision
- Willingness to do whatever needs to be done, regardless of level or type of work
- Comfortable in a fast-paced small company environment with minimal direction and adjust workload based upon changing priorities
- Excellent verbal and written communication skills are essential in this collaborative work environment
- Travel requirements: ~25%
Plexxikon, an equal opportunity employer, is located in Berkeley, just off interstate 80. We offer a chance to work with talented people in a collaborative environment and provide excellent benefits including health insurance, an annual performance bonus and long-term incentive program, generous time off and much more. To learn more about Plexxikon, please visit our website at www.plexxikon.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
Please no phone calls, agencies or recruiters