![AbbVie](https://media.trabajo.org/img/noimg.jpg)
Senior Medical Director, Oncology Early Development
1 month ago
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Senior Medical Director leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVies customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Qualifications
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to run a complex clinical research program independently.
Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
Ability to interact externally and internally to support a global scientific and business strategy.
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
Must possess excellent oral and written English communication skills.
Ability to exercise judgment and address complex problems and create solutions for one or more projects.
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
-
South San Francisco, California, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
-
South San Francisco, California, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
-
South San Francisco, United States AbbVie, Inc Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...
-
South San Francisco, United States AbbVie, Inc Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...
-
South San Francisco, United States AbbVie Full timeJob DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...
-
South San Francisco, United States AbbVie Full timeJob DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...
-
South San Francisco, United States AbbVie Full timeJob DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...
-
South San Francisco, United States AbbVie Full timeJob DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...
-
Director, Early-Stage Clinical Development
2 weeks ago
South San Francisco, California, United States Pliant Therapeutics Full timePliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the...
-
Vice President, Clinical Development
2 months ago
San Francisco, United States Scorpion Therapeutics Full timeScorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data...
-
Vice President, Clinical Development
4 weeks ago
San Francisco, United States Scorpion Therapeutics Full timeScorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data...
-
Medical Director
1 month ago
San Francisco, United States Olema Oncology Full timeWho We Are >>> Why You Should Work With Us Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen...
-
Clinical Scientist/Sr. Clinical Scientist
2 months ago
San Francisco, United States Scorpion Therapeutics Full timeScorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data...
-
Clinical Scientist/Sr. Clinical Scientist
4 weeks ago
San Francisco, United States Scorpion Therapeutics Full timeScorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data...
-
Medical Director
1 month ago
San Francisco, United States Olema Oncology Full timeWho We Are >>> Why You Should Work With UsOlema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen...
-
Medical Director
4 weeks ago
San Francisco, United States Olema Oncology Full timeWho We Are >>> Why You Should Work With UsOlema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen...
-
Director, Oncology Research
1 month ago
South San Francisco, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better...
-
Director, Oncology Research
4 weeks ago
South San Francisco, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better...
-
Director, Oncology Research
1 month ago
South San Francisco, United States Amgen Inc. Full timeJOB ID: R-183619 LOCATION: US - California - South San Francisco WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Mar. 06, 2024 CATEGORY: Research SALARY RANGE: 191,600.00 USD - 236,280.00 USD HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives...
-
Director, Oncology Research
4 weeks ago
South San Francisco, United States Amgen Inc. Full timeJOB ID: R-183619 LOCATION: US - California - South San Francisco WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Mar. 06, 2024 CATEGORY: Research SALARY RANGE: 191,600.00 USD - 236,280.00 USD HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives...