Medical Director
1 month ago
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 receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.
Onto something big, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things - for each other, for science, and for women with cancer.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time - whether that's picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.
About the Role >>> Medical Director
As the Medical Director of Clinical Development reporting to the VP of Clinical Development Operations, you'll play an instrumental role in guiding the successful clinical development efforts as the oncology physician lead.
Collaborating with project teams, you'll plan, design, and execute clinical development research studies to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of OP-3136 and future therapies.
This role may be based in the San Francisco or Cambridge office and will require up to 20% travel.
Your work will primarily encompass:
Functioning as a Medical Expert
- Serve as medical lead for clinical studies with OP-3136, including contributing to the design of studies, interacting with regulatory authorities and investigators, and starting up related medical/operational activities.
- Provide consulting on the clinical perspective for various internal functions.
- Interface and lead interactions with investigators, academics, and thought leaders in a variety of settings including academic society meetings, advisory boards, and investigator meetings.
- Attend scientific meetings pertinent to clinical science activities.
- Maintain clinical and scientific awareness in area of expertise.
Designing and Executing the Studies
- Develop related reports and resources, including additional clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts, and clinical study reports in collaboration with the clinical development team.
- Ensure data quality, summary, and writing of clinical study report in close collaboration with the clinical operations, biometrics, and CRO oversight teams.
- Evaluate the safety, pharmacology, and efficacy of ongoing and completed studies in close collaboration with the safety and clinical operations teams.
- Work on regulatory submission documents.
- Establish and implement exploratory pharmacodynamic, predictive, and prognostic biomarker plans in conjunction with pre-clinical scientists, consultants, and collaborators.
- Ensure adherence to Olema's Standard Operation Procedures and values, maintaining the highest level of ethical behavior and leading by example.
Ideal Candidate Profile >>> Experienced Oncology Physician Lead
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge:
- MD degree or equivalent, with at least 2 years of experience in drug development is required.
- Significant experience in early phase clinical trials in solid tumors is required.
- Experience in breast cancer or prostate cancer is a plus.
Experience:
- An understanding of pharmacokinetics and biomarkers in clinical trials is required.
- Designing, leading, and managing industry led early phase clinical studies in solid tumors strongly preferred.
- Demonstrated understanding of the drug development process evidenced by the 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.
- Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus.
- Effectively evaluating outside expert advice.
- Communicating and explaining oncologic technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.
- Proactively identifying challenges/problems and proposing solutions with a strong sense of urgency.
- Presenting clearly using scientific and clinical terminology.
- Demonstrated success motivating both internal and external team members and collaborators, fostering and nurturing teamwork.
Attributes:
- Excellent communicator who can represent the program and engage external business partners, academics, and regulatory bodies.
- Ability to work in a diverse and dynamic cross-functional team.
- Independent worker who can effectively head and participate in a team.
COMP RANGE TEXT:
The base pay range for this position is expected to be $285,000 - $295,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-AD1
Important Information >>>
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.
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